AGENDA OF 203RD MEETING OFCENTRAL LICENSING & DRUGS REGISTRATION by 2yzt4qZ

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									     MINUTES OF 203RD MEETING OFCENTRAL LICENSING & DRUGS
            REGISTRATION BOARD HELD ON 23RD DECEMBER, 2006
                                           (REG-II SOUTH)


                      The 203rd meeting of the Drug Registration Board was held on 23rd December,
2006 in the Committee Room of Ministry of Health, Islamabad which was chaired by Maj. Gen
® Dr. Shahida Malik Director General Health. It commenced with the recitation of verses from
the Holy Quran. The meeting was attended by the following members:-

1.         Maj. Gen ® Nasir-ul-Islam
           Rawalpinid.

2.         Lt. Col. Aslam Khan
           Pulmanologist,
           Army Medical College, Rawalpindi

3.         Mr. Abdul Latif Sheikh,
           Director,
           Pharmacy, Nutrition & CSSD Services,
           Agha Khan University Hospital, Karachi

4.         Dr. Ijaz Ahmed, Associate Professor,
           University of Veterinary and Animal Sciences,
           Lahore.

5.         Dr. IU Baig,
           Consultant Surgeon,
           Federal Government Services Hospital,
           Islamabad.

6.         Prof. Dr. Muhammad Jamshaid,
           Principal, University College of Pharmacy,
           University of the Punjab, Lahore.

7.         Dr. R.H. Usmani,
           Animal Husbandry Commissioner
           M/o. Food, Agriculture & Livestock,
           Islamabad

8.         Mr. Muhammad Saad Quershi,
           Deputy Secretary, M/s. Law, Justice & Human Rights,
           Islamabad.

9.         Deputy Secretary,
           M/o. Industries & Production,
           Islamabad.
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10.        Representative of Director General Health Services,
           Government of NWFP,
           Peshawar

11.        Mr. Amanullah
           Cost Accountant,
           M/o. Health, Islamabad.

12.        Dr. Farnaz Malik,                                     (Also Secretary of the Board)
           Drugs Controller, Ministry of Health,
           Islamabad.


                      Ghulam Rasool Dutani, Deputy Director General (Registration) Mr. Abdul Sattar

Sohrani Deputy Drugs Controller (Registration-II South) and Mr. Muhammad Akhtar Abbas

Khan Deputy Drugs Controller (Registration-II North), assisted the Secretary of the Board with

the agenda and working paper.

                      Mr. Zahid Saeed representative of Pakistan Pharmaceutical Manufacturers

Association, Mr. M.Zafar Mooraj, Advisor to Pharma Bureau, Karachi,                Representative of

Pakistan chemists and Druggists Association, Karachi and Mr. Ayaz Kiani representative of the

Network for Consumer Protection also attended the meeting as observers.


ITEM NO. I


1.         VITAMIN POLICY


           In a meeting of PPMA & Pharma Bureau with Drugs Controller on 16th December, 2006
it was principally agreed that vitamin and mineral preparations should be divided into two
categories as exercised at the international level.


           i.         Food Supplements: Preparations containing vitamins and minerals in quantities
at the level of Required Dietary Allowance (RDA). RDA quantities are annexed as (annexure
A)




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           ii.        Therapeutics vitamins and minerals:      Preparations containing vitamins and
minerals in quantities above the RDA quantities intended for prophylactic or therapeutic use will
be deemed as therapeutic class.


           Vitamins are generally regulated by various policies on international level. Mostly
vitamin preparations are divided into two classes. Only the rationale formulations may be
registered as drug. Gross misuse and over use of B1, B6 & B12 combinations is prevalent which
are easily available in the food. A large number of multi vitamins preparation are available which
are used for short gun vitamin therapy in the treatment of deficiencies of only one vitamin which
could be dangerous for example in the deficiency of Vitamin B12, use of multi vitamins will
mask the continued deficiency of Vitamin B12 resulting in Neurological damage, if already
present. Similarly in take of combinations of multi vitamins with minerals may also result in
renal failure due to accumulation of minerals in the body.


           Vitamins, minerals, amino acids and metabolites are registered as drugs under Section 7
of Drugs Act, 1976. A number of multinational and local pharmaceuticals are manufacturing
these products duly registered by the Ministry of Health.


           A.         Food Supplements or Dietary Supplements.

                      Developed countries like America have exempted these preparations from the
registrations but they are regulating the Good Manufacturing Practices (GMP) and labels claims.
However, only oral preparations are being exempted for this purpose, in concentrations below
the recommended minimum daily requirements. The manufacturers are required to ensure the
safety, identity, purity, strength and composition of the food supplements containing these
ingredients.
                      These are defined as supplements containing dietary ingredients intended to
supplement the diet. Dietary ingredient may include vitamins, minerals, herbs or other
botanicals, amino acids and substances like metabolites. Dietary supplements may be found in
the form of tablet, capsule, soft gels, gel caps, liquid juices or powders.


                      In USA food supplements are being regulated under the Dietary Supplements
Health and Education Act of 1994, which is regulating the manufacturing practices and label
claims and Federal Trade Commission regulates the advertising practices and FDA is


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responsible for the post marketing surveillance for safety including adverse effect reporting
product information label claims, package inserts and accompanying literature.

                      Following conditions may be included for the regulation of food supplements.

                      a.         Food supplements would be purely meant for nutritional purpose and no
                                 claims will be made about prevention, cure, diagnosis, mitigation or
                                 treatment of diseases.
                      b.         Their advertisement will be regulated to Section 24 of Drugs Act, 1976
                                 and it will not be allowed to be promoted as drugs.
                      c.         Onus about safety will be on the manufacturers of food supplements.
                      d.         The standards labels will be displayed on the official website and all
                                 manufacturers would be required to comply with these labels.
                      e.         The manufacturer of food supplements shall notify the ingredients of the
                                 formula of the product with the condition that the ingredients are
                                 reasonably expected to be safe for use in the dietary supplement unless it
                                 has been recognized as a food substance and is present in the food supply.
                      f.         FDA regulations require the information that must be included on the label
                                 of the dietary supplements as under:-
                                          Descriptive name of the product stating that it is a supplement.
                                          Name and business place of the manufacturer.
                                          Complete list of the ingredients.
                                          Net content of each ingredient in the product.
                                           In each supplement must have nutrition labeling in the form of
                                           supplements facts panel.
                                          This label must identify each ingredient contained in the product.
                                          The type of ingredients listed may include the source of dietary
                                           ingredient if not identified in the supplements facts panel.
                                          Technical additives and processing aids i.e. inactive ingredients
                                           may also be displayed on the label.
                                          Manufacturer does not need approval of the FDA, however, to
                                           ensure safety onus lies on the manufacturer.
                                          Once the product is marketed FDA has responsibility for showing
                                           that a dietary supplement is unsafe, before it can be taken to
                                           restrict the product‟s use or removal from the market.
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                                          No evidence is required for the addition of ingredients into the
                                           food supplements for the already available dietary ingredients.
                                          Addition of new dietary ingredients requires evidence before the
                                           start of marketing of the products contains such ingredients.
                                          Consumers are authorized to register their complaints with
                                           evidences about the safety of the dietary supplements.
                                          FDA can investigate and monitor the market place for potential
                                           illegal products i.e. products that may be unsafe or make falls or
                                           misleading claims including inspections of dietary supplements
                                           manufacturers and distributors.
                                          The manufacturer is responsible for ensuring that the supplements
                                           facts label and ingredient list are accurate, the dietary ingredients
                                           are safe and the content matches the amount declared on the label.
                                          The consumers may contract manufacturer or a commercial
                                           laboratory for analysis of the contents.
                                          The food supplement cannot be sold or promoted on its label or
                                           labeling for the treatment, prevention or cure of diseases are
                                           conditions.
                                          The labels must be consistent with the provisions of the dietary
                                           supplement health and education act.
                                          FDA receives may consumers inquiry about the validity of claims
                                           for supplements included labels, advertisements, media and printed
                                           materials. The responsibility for ensuring the validity of these
                                           claims rests with the manufacturer, FDA and in case of advertising
                                           with the Federal Tariff Commission.
                                          The manufacturers may make three types of claims i.e. health
                                           claims, structure and functions claims and nutrient content claims.
                                          Some of these claims prescribed linked between the food substance
                                           and health related condition, intended benefit of using the product
                                           and amount of the dietary substance or nutrient in a product.
                                          Disclaimer that the product is not intended to diagnose, treat,
                                           prevent or cure and disease.
                                          Federal Tariff Commission (FTC) regulates the advertisement for
                                           dietary supplements. FDA closely works with the FTC.
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                      g.         The food supplements are exempted form the Section 7 of Drugs Act,
                                 1976 for the purpose of registration. However, quality control and other
                                 parameters will be regulated under the Drugs Act, 1976.
                      h.         Only the licence manufacturer can manufacture food supplements in
                                 licenced sections dedicated for food supplements.
                      i.         The prices of the food supplements would not be increased beyond limits.
                                 This would be decided by the PRC      as a principle guideline.
                      j.         Only the approved food supplements from FDA & UK would be permitted
                                 for import in Pakistan with the free sale certificate from both regulatory
                                 authorities.
                      k.         Prior NOC will be required for the import of food supplements.
                      l.         The amount of dietary ingredient shall be at maximum to the required
                                 daily allowance and must not increase above this range.
                      m.         All the provisions of the Drugs Act, 1976 will be applicable except
                                 Section 7 & Section 12 of Drugs Act, 1976. However, the Federal
                                 Government may intervene in case of unreasonable price increases.
                      n.         Food supplements containing the quantities of the dietary ingredients
                                 about the notified level will be deemed as unregistered drugs.
                      o.         If food supplement does not contain any ingredient mentioned on its label
                                 will be deemed as spurious under Drugs Act, 1976.
                      p.         Food supplement does not containing labeling information as notified in
                                 the standard label would be deemed as misbranded under Section 3 of
                                 Drugs Act, 1976.
                      q.         The Federal Government may issue recall and withdrawal directions for
                                 the food supplements declared unsafe or substandard and spurious.


           B.         Therapeutic Vitamins Etc.


                      If the content of vitamins and other ingredients is intended for therapeutic used
such ingredients would be registered under the Drugs Act, 1976 after fulfilling all the legal
requirements in addition to the following:-


           i.         All Vitamins should be prepared as single ingredients.


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           ii.        Vitamins will not be allowed to be combined with any other ingredient
                      such as minerals and glycerophosphate except combination of Iron with
                      folic acid.
           iii.       It will be allowed that vitamins shall be produced only in tablets
                      capsules and injectable forms as active ingredients.

           iv.        No liquid will be permitted because of wastage of financial resources
                      and tremendous misuse involved.

           v.         However, pediatric liquid of vitamins will be allowed to be
                      manufactured in 15ml bottles only.

           vi.        Combination of vitamins with analgesic or antibiotics will not be
                      allowed except combination of pyridoxine with INH.

           vii.       Import of Vitamins preparations will not be allowed and local
                      manufacturing by local pharmaceutical firms will be encouraged.

           viii.      Fixed dose combinations of Vitamins will not be allowed except valid
                      clinical justifications supported with scientific material.

           ix.        Fixed dose combinations Vitamins with minerals and other drugs will
                      not be allowed except combination of Vitamin B6 with Anti
                      Tuberculoses drugs.


           x.         All the already registered formulations in violation of these guidelines
                      shall be withdrawn / consumed within a period of 6 months. After this
                      period manufacturing / sale of such combinations will not be allowed.

           xi.        This will save almost two billion rupees annually which are wasted
                      without benefiting the patients.

           xii.       This will also overcome the adverse effects due to the accumulation of
                      heavy metals resulting in renal failure after taking Vitamins and
                      minerals in combinations on prolonged used.
           xiii.      All the Vitamins formulations registered as drugs shall contain not less
                      than and more than quantities as prescribed below for the purpose of
                      prophylactic and therapeutic uses in adults, children and infants.

           xv.        Registration of Minerals for prophylactic or therapeutic use will also be
                      considered as single ingredient.


           Fears about Deregulations

                                The quality of these products may become questionable in the
                                 absence of regulation like the Unani and Herbal preparations
                                 which are being manufactured and mushroom manufacturers may
                                 start manufacturing in streets and mohallahs.
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                                The prices of these products will increase.

                                Unethical marketing practices which are already prevailing may
                                 also become threat especially for the poor ones.

                                Large number of preparations registered will be required to be
                                 deregistered before the deregulation because a preparation once
                                 registered becomes the part of legislation and could not be
                                 deregulated.




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     Vitamin                       Unit      Patent or Properitary          Patent or proprietary         Patent or proprietary medinces containing vitamins
                                             medicines containing         medinces containg vitamins                       for paediatric use
                                           vitamins for prophylactic         for therapeutic use
                                                      use

                                                                                                          In Single dose or in two divided doses) per daily dose

                                                                   For adults                             For infants less than one   For children abaove one
                                                                                                                    year                 year up to adults

       1                              2                 3                              4                              5                           6
   Vitamin A                        I.U.   Not less than 1,600 and not    Not less than 5,000 and not     Not less than 750 and not    Not less than 1,500 and
                                                more than 2,500                more than 10,000               more than 3,000           not more than 5,000

   Vitamin D                        I.U.   Not less than 100 and not     Not less than 400 and not more   Not less than 200 and not   Not less than 100 and not
                                                more than 200                       than 1,000                 more than 400               more than 400

  Vitamin B1                        mg.      Not less than 1 and not     Not less than 4.5 and not more   Not less than 0.5 and not    Not less than 1 and not
                                                  more than 2                        than 10                    more than 1                more than 4.5

  Vitamin B2                        mg.      Not less than 1 and not      Not less than 5 and not more    Not less than 0.5 and not    Not less than 1 and not
                                                  more than 3                        than 10                   more than 1.5                more than 5

  Vitamin B6                        mg.    Not less than 0.5 and not     Not less than 1.5 and not more   Not less than 0.5 and not    Not less than 1 and not
                                                 more than 1.5                        than 3                    more than 1.5                more than 3

 Niacinamide                        mg.     Not less than 15 and not     Not less than 45 and not more     Not less than 5 and not    Not less than 10 and not
                                                 more than 26                       than 100                    more than 15               more than 40

d-Pantothenic                       mg.      Not less than 1 and not      Not less than 5 and not more     Not less than 1 and not    Not less than 2.5 and not
acid or its alts                                  more than 5                        than 50                    more than 3                 more than 10
andpanthenol.




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   Folic acid                      mcg.         Not less than 50 and not     Not less than 1,000 and not    Not less than 25 and not    Not less than 100 and not
                                                     more than 300                more than 1,500                more than 100               more than 500

     1                               2                      3                             4                            5                            6
Vitamin B 12                        mg.         Not less than 0.5 and not   Not less than 5 and not more    Not less than 1 and not      Not less than 1 and not
                                                     more than 1.0                     than 15                   more than 3                  more than 5

   Vitamin C                        mg.         Not less than 25 and not    Not less than 75 and not more   Not less than 20 and not    Not less than 30 and not
                                                     more than 50                      than 150                  more than 40                more than 80

   Vitamin E                        I.U.         Not less than 5and not     Not less than 15 and not more   Not less than 2.5 and not    Not less than 5 and not
                                                     more than 10                       than 25                   more than 10                more than 20



Decision:                 After consideration in depth, the Drugs Registration Board constituted a committee of following members to formulate Vitamin policy
in accordance with the international practices:-




                          i.           Prof. Dr. Muhammad Jamshaid
                          ii.          Abdul Latif Sheikh
                          iii.         Col. Muhammad Aslam
                          iv.          Gen. ® Nasir-ul-Islama


                          This Committee will submit its recommendation within one month which will be placed in the forth coming meeting of CL & RB.




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ITEM NO. 2


QUALITY CONTROL / ASSURANCE


             A.           Incentives:         The manufacturers will be ranked in A, B & C classes keeping in
view their achievements, GMP compliance and compliance to the Drugs Act, 1976 and rules
framed there under:-


             Class A :                 The manufacturing unit whether local or multinational would be classified
in Class A, if such unit achieves certification from, FDA, European Union, WHO, TGA or Japan
Regulatory Authority. These units would be granted with best awards in addition to the special
permissions on labels and will also be enabled for special price incentives. These units will also
be recognized for government purposes for their products without any pre-qualification or
competition. These units will also be entitled for the grant of new registrations with special quota
above the other units below their category. They will be allocated special quota of Psychotropic
/ Narcotic drugs, which would be better than Class B.


             Class B:                  Manufacturing units complying to the Good Manufacturing Practices
would be classified as Class A. Such units would be entitled for competent prices subject to
compliance to the Drugs Act, 1976 and rules framed there under. They will be encouraged for
registration to a specific limit below the category A . They will be entitled for government
purchase. They will be allocated special quota of Psychotropic / Narcotic drugs.


             Class C:                  Manufacturing units who are complying with the GMP but due to lack of
their commitment are involved in the violation o Drugs Act, 1976 and rules framed there under.
Their sample failure or system failure is also identified they would be classified as category C.
They would not be allowed for any registration until they identify and rectify their lapses and
satisfy the regulators. Their registrations would be considered on complete compliance.


             Class D:                  The manufacturing units which are non GMP compliant and also involved
in the violation of Drugs Act, 1976 and rules framed there under, they will be classified as Class
D. All the facilitation to such units will be freezed. They will not be allowed to manufacturer
Psychotropic / Narcotics drugs. They will also be banned for government purchases and one year



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period would be given to them for improvement of facilities. Those drugs which will fail will be
un-eligible for the government purchases.


             Class D firms could not participate in public sector purchases whereas Class B firms
will not be permitted for only those sections which will not comply with the requirements of
Drugs Act, 1976 and rules framed there under. For this purpose GMP CERTIFICATES
ATTRIBUTING EXCELLENT, VERY GOOD AND GOOD will be issued on annual basis to
reflect the performance of manufacturer. Rest of the classes will not be granted with any GMP
certificate until the qualify with the requirements. This policy will drive towards the
improvement of GMP standards in addition to the availability of quality drugs in the public
sector.


             B.           Testing labs and centers:         To attract investment in this sector, Ministry of
Health would encourage the establishment of laboratory of international standards which would
be issued licences to practice and out source their facilities to the private sector as well as public
sector. Those manufacturers did not having such facilities would be allowed for testing on
contract basis ad reports of these labs would be competent for reliance. The manufacturers would
also be encouraged for this purpose. Similarly bioequivalence centers could also be certified for
out sourcing their facilities for the utilization of local industry.




Decision:                 The Drugs Registration Board after through discussion approved that only class A
should be considered in the light of following decision:-


                       i.              The manufacturing unit whether local or multinational would be classified
                          in Class A, if such unit achieves certification from, FDA, European Union, WHO,
                          TGA or Japan Regulatory Authority. These units would be granted with best
                          awards in addition to the special permissions on labels incentives. These units will
                          also be recognized for government purposes for their products without any pre-
                          qualification or competition. These units will also be entitled for the grant of new
                          registrations.




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ITEM NO. 3

             REGULATION OF DRUGS OF ABUSE AND SUBSTANCES RULES, 2006.

CHAPTER 1:

1.           Short Title and Commencement: (1) These rules may be called regulations of drugs
of abuse and substances rules 2006.

             (2)          They shall come into force at once.


2.           Definitions:- (1) In these rules unless there is any thing repugnant in the subject or
context:-

             (i)          “Act” means control of narcotics substances Act, 1976 (XXXI of 1976).

             (ii)         “analogue” means any substance not listed in any Schedule of these rules
                          whose chemical structure is substantially similar to any drug of abuse
                          whose psychoactive effect it simulates:

             (iii)        “animal” includes fish, birds, invertebrates or other fauna;

             (iv)          “Competent Authority means Secretary Health Government of Pakistan
                          for Federal purpose and Secretary Health Department of Provincial
                          Governments for Provincial purpose.

             (v)          controlled substance” means raw material of the any drug of abuse, listed
                          as such in any schedule under these rules;

             (vi)         “convention State” means a State which is a party to the United Nations
                          Convention against illicit Traffic in Narcotic Drugs and Psychotropic
                          substances, 1988;
             (vii)         “data means representations, in any form, of information or concepts;

             (viii)       dentist” means any person who is registered under the Medical and Dental
                          Council Ordinance, 1962 (XXXII of 1962), and entitled to practice the
                          profession of dentistry;

             (ix)         “drug dependent person” in relation to a drug of abuse or analogue, means
                          any person who has such a condition that:-

                          (a)          administration of the drug to him or her results in the person
                                       demonstrating impaired control in relation to the use of that drug,
                                       or drug-seeking behavior suggesting such impaired control; or




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                          (b)          cessation of the administration of the drug is likely to result in the
                                       person experiencing symptoms of mental or physical distress or
                                       disorder;

             (x)          „drug of abuse” means a prohibited drug, a high-risk drug, or a risk drug,
                          and includes a preparation;
             (xi)         “foreign State” means:- Any country other than Pakistan; and

             (xii)   “high-risk drug” means a substance listed in Schedule I;
             (xiii) “Inspector” means any person appointed under Drug Act, 1976”

             (xiv)        “institution” means a hospital, nursing home or other institution used for
                          the accommodation, treatment and care of persons suffering from
                          physical or mental conditions;

             (xv)         “International Drug Control Conventions” means:-

                          (a)          the Single Convention on Narcotic Drugs done at New York on the
                                       30th March, 1961, as amended by the 1972 Protocol amending the
                                       Single convention done at Geneva on the 25th March, 1972;

                          (b)          the Convention Against Psychotropic substances done at Vienna
                                       on the 21st February, 1971”

                          (c)          the United Nation Convention Against illicit Traffic in Narcotic
                                       Drugs and Psychotropic Substances done at Vienna on the 20th
                                       December, 1988; and

                          (d)          any other international convention to which Pakistan may be come
                                       party after the commencement of these rules relating in whole or
                                       in part to the control of drugs of abuse, controlled chemicals or
                                       controlled equipment;

             (xvi)        “medical practitioner” means any person who is registered under the
                          Medical and Dental Council Ordinance, 1962 (XXXII) of 1962), and
                          entitled to practice the profession of medicine;

             (xvii) “open individual authorization” means an authorization permitting an
                    operator to export from Pakistan such quantities of such controlled
                    chemical , equipment of materials to such countries or regions during such
                    periods as may be specified in the authorization;

             (xviii) “operator” means any person who carries on a business of the
                     manufacture, acquisition or supply of a drug of abuse, intended for
                     medical, scientific use or other lawful use

             (xix)        “permit” means a permit or authorizations issued under these rules for
                          lawful purpose.

             (xx)         person” means any natural or legal person:

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             (xxi)        “pharmacist” means any person who is registered under the Pharmacy Act,
                          1967 (XI of 1967) and entitled to practice the profession of pharmacy;

             (xxii) practitioner means:-

                          (a) a dentist, medical practitioner or veterinary surgeon;

                     (b) any person who is entitled under the laws of Pakistan to practice any
                         other profession whose members may lawfully prescribe, dispense or
                         administer any drug of abuse;
             (xxiii) “premises” includes the whole or any part of a structure, building, aircraft,
                     or vessel used for storage, manufacturing, sale, distribution, administration
                     or transportation of drugs abuse

             (xxiv) “Prescription” means a written direction by a practitioner that a stated
                    amount of a drug abuse be dispensed for the person named therein;

             (xxv) “prohibited drug” means a substance specified in Schedule 1;

             (xxvi) “record means any material on which data are recorded or marked and
                    which is capable of being read or understood by a person, computer
                    system, or other device;

             (xxvii) “risk drug” means a substance specified in Schedule III;

             (xxviii) “Schedule” means a Schedule to these rules;

             (xxix)        “supply” includes sale, consignment, dispatch, transport, delivery,
                          distribution, dispensing, as well as offer to supply and transportation.

             (xxx)         “transit” means the physical transfer of any drug of abuse, into and out
                          of, the territory of Pakistan:-

                          (a)          without it passing through Pakistan customs; and

                          (b)              where Pakistan is neither its country of origin nor destination;

             (xxxi) “veterinary surgeon” means any person who is registered under the
                    Pakistan veterinary Medical Council Act, 1962 and is entitled to practice
                    the profession of veterinary medicine; and


CHAPTER 2

1.           Classification and Scheduling of Drugs of Abuse: (1)                        Each of the drugs of abuse to
which these rules apply is classified by the Schedule in which it appears under its international
non-proprietary name or, lacking such a name, under its scientific name.



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             (2)          The threshold issue whether the drug or other substance has potential for abuse
             shall be considered on the basis of following indicators:-

                          a).          There is evidence that individuals are taking the drug other
                                       substance in amounts sufficient o create a hazard to their health or
                                       to the safety of other individuals or to the community; or

                          b)           There is significant diversion of the drug or other substance from
                                       legitimate drug channels; or
                          c)           Individuals are taking the drug or other substance on their own
                                       initiative rather than on the basis of medical advice from a
                                       practitioner licensed by law to administer such drugs; or

                          d).          The drug is a new drug so related in its action to a drug or other
                                       substance already listed as having a potential for abuse to make it
                                       likely that the drug will have the same potential for abuse as such
                                       drugs, thus making it reasonable to assume that there may be
                                       significant diversions from legitimate channels, significant use
                                       contrary to or without medical advice, or that it has a substantial
                                       capability of creating hazards to the health of the user or to the
                                       safety or the community. Evidence of actual abuse of a substance
                                       is indicative that a drug has a potential for abuse.

             (3)          For determination of a drug or a substance should be placed in to which schedule
             or be exempted and should be decontrolled or rescheduled following factors shall be
             considered.
                          a)           The drug‟s actual or relative potential for abuse.

                          b)           Scientific evidence for the drug‟s pharmacological effects.
                          c)           The state of current scientific knowledge regarding the substance.
                          d)           Its history and current pattern of abuse.
                          e)           The scope, duration, and significance of abuse.
                          f)           What, if any, risk there is to the public health.
                          g)           The drug‟s psychic or physiological dependence.
                          i)           Whether the substance is an immediate precursor of a substance already
                                       controlled.
                          k)           Whether the substance is analogue of a substance already controlled.

             (4)          Federal Government shall maintain and notify the schedules on the basis of
             scientific evidences, diversion towards abuse or any other criteria prescribed under these
             rules.
             (5)          The schedules for the drugs of abuse shall be established as follows:-




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             Schedule I

             The substances in this schedule have a high abuse potential and no accepted medical use.
             This schedule that include drugs that are not available for prescribing, dispensing or
             administering due to the following reason:-

             a)           The drug or other substance has a high potential for abuse.
             b)           The drug or other substance has no currently accepted medical use in treatment.
             c)           There is a lack of accepted safety for use of the drug or other substance under
                          medical supervision.

             List of Drugs

             i.           Heroin
             ii.          Fentanyl Analogs
             iii.         LSD
             iv.          Marijuana
             v.           Sufentanil
             vi.          Alfentanil
             vii.         Amphetamine

             Schedule II

             a)           The drug or other substance has a high potential for abuse.
             b)           The drugs or other substance has a currently accepted medical use in treatment or
                          a currently accepted medical use with severe restrictions.
             c)           Abuse of the drug or other substance may lead to severe psychological or physical
                          dependence.

             List of Drugs

             i.           Benzethidine
             ii.          Clonitazene
             iii.         Clonitazene
             iv.          Diphenoxylate
             v.           Fentanyl
             vi.          Metazocine
             vii.         Methadone
             viii.        Pethidine
             ix.          Buprinorphine
             x.           Hydrocodone
             xi.          Meperidine
             xii.         Methylpheridate

             Schedule III

             a)           The drug or other substance has less potential for abuse than the drugs or other
                          substances in schedules I and II
             b)           The drug or other substance has a currently accepted medical use in treatment.

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        c)      Abuse of the drug or other substance may lead to moderate or low physical
                dependence or high psychological dependence.

        List of Drugs

        i.      Anabolic Steroids
        ii.     Codeine
        iii.    Benzphetamine
        iv.     Amobarbital
        v.      Secobarbital
        vi.     Pentobarbital
        vii.    Ketamine
        viii.   Dextropropoxephene
        ix.     Dronabinol
        xi.     Amarital
        xii.    Butabital
        xiii.   Glutethimide
        xiv.    Pentazocine
        xv.     Flunitrazepam

        Schedule IV

        a)      The drug or other substance has a low potential for abuse relative to the drugs or
                other substances in schedule III.
        b)      The drug or other substance has a currently accepted medical use in treatment.
        c)      Abuse of the drug or other substance may lead to limited physical dependence or
                psychological dependence relative to the drugs or other substances in schedule III.

        List of Drugs

        Alloarital            Clorazepate           Haloxazolam
        Alprazolam            Clotiazepam           Ketazolam
        Barital               Cloxazolam            Loprazolam
        Bromazepam            Delorazepam           Midazolam
        Butobarbital          Diazepam              Nimetazepam
        Camazepam             Fenproporex           Nitraxepam
        Chlordiazepoxide      Flurazepam            Phenoarital
        Clobazam              Halazepam             Piptadrol
        Praze                 Butorphanol           Clonazepam
        Lorazepam             Orazepam              Prazepam
        Temazepam             Quazepam              Trizolam
        Phenobarbital         Chloral Hydrate       Ethchlorvynol
        Ethinamate            Meprobamate           Paraldehyde
        Methohexital          Phentermine           Diethylpropion
        Pemoline              Mazindol              Subutramine

        Schedule V

        a)                The drug or other substance has a low potential for abuse relative to the drugs or
                          other substances in schedule iv.
             b)           The drug or other substance has a currently accepted medical use in treatment.
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             c)           Abuse of the drug or other substances may lead to limited physical dependence or
                          psychology al dependence relative to the drugs or other substances in schedule iv.

             List of Drugs

             i.           Antitussive Cough Syrups containing Codeine more than 200mg per 100ml.
             ii.          Codeine above 50mg
             iii.         Buspirone

             (2)          The Competent Authority may, be order in writing, exempt any preparation
             containing:-
                          (a)          a drug of abuse specified in Schedule II or III from such measure of
                                       control provided in these rules, when the Competent Authority is satisfied
                                       that:-

                                        (i) the preparation is compounded in such a way as to present no or
                                            negligible risk of abuse; and
                                       (ii) the drug of abuse cannot be readily recovered from it in a quantity
                                            liable to present such a risk; and

                          (b)          a controlled chemical, when the Competent Authority is satisfied that it is
                                       in such a state that the chemical cannot easily be used for the illicit
                                       manufacture of a drug of abuse.

             (3)          The Competent Authority shall not exempt any preparation, under sub-rule

                          (a)          In so far as it relates to the manufacturer, import or export of preparations
                                       containing high risk drugs or risk drugs, or the making and keeping of
                                       records relating to such activities; and

                          (b)          Otherwise, except to the extent if any to which it may be exempted under
                                       any international drug control convention applicable to the particular
                                       preparation or class of preparation.

             (4)          The Competent Authority shall maintain a register of the preparation exempted
             under this section, specifying in relation to each such preparation each control measure
             from which it is exempted.


Chapter 3

REGISTRATION AS DRUGS

1.           Requirement For Registration Of Drugs Of Abuse:- (1) Drugs Registration Board is
competent for the grant of registrations of the drug of abuse for the purpose of treatment subject
to the following conditions:-

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           (i).           Drugs Registration Board may not grant registration for the drugs included
                          in Schedule 1. Drugs listed in Schedule 2 shall be allowed only for the
                          institutional supplies in the public and private sectors institutions.
         (ii).            A manufacturer may obtain registration of only one drug product listed in
                          Schedule 2.
        (iii).            A manufacturer may obtain registration of only two drugs products listed
                          in Schedule 3.
         (iv).            A manufacturer may obtain registration of only two drug product listed in
                          Schedule 4.
          (v).            A manufacturer may achieve registration of only two drug products listed
                          in Schedule 5.
         (vi).            The maximum number of manufacturers for each drug may not exceed
                          from 10 fro each molecule.
       (vii).             Bioequivalence studies will be applicable for the grant of registration for
                          drugs where pharmacopoeias require the same.
      (viii).             Manufacturers achieving very good cGMP recommendations are entitled
                          for the registrations.
         (ix).            The manufacturer of the drug is obeying all the provision of the Drugs
                          Act, 1976 and rules framed there under.
          (x).            A manufacturer may get five registrations of the drugs of abuse.
         (xi).            Violation to any of the provisions of these rules shall lead to the
                          cancellation of drugs registrations.
       (xii).             New manufacturing units may apply for the grant of registration of drugs
                          of abuse after a period of five years from the grant of Drugs
                          Manufacturing Licence.
      (xiii).             The manufacturers have security arrangements for the storage of drugs of
                          abuse and substances.
      (xiv).              The manufacturers have good reputation and his annual turnover is more
                          than 50 millions. He is also contributing reasonable amount of Central
                          Research Funds.
       (xv).              The registration once granted shall be valid for period of two years.
      (xvi).              Renewal of the registration shall be permissible subject to the fulfillment
                          of all the provisions of these rules.


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     (xvii).              Import of Psychotropic / Narcotic drugs in finished form shall not be
                          allowed. Those firms availing already import of these drugs shall either
                          start local manufacturing or surrender the registrations.

     (xviii).             Payment for sale of these drugs by the manufactures to the distributors
                          shall be through bank checks / pay order on specifically designed invoices
                          marked with the World Psychotropic / Narcotic and record of these
                          invoices shall be provided to the Provincial and Federal Authorities.

      (xix).              Sale of these drugs by the authorized agents of manufacturers shall be
                          directly to the retail outlets along with government hospitals / institutions
                          and no sale shall be permissible to the unauthorized wholesalers.

       (xx).              Sale of drugs of abuse shall be conducted only two those outlets
                          supervised by the A category pharmacists.

             2.                     Application for Registration / Drug Sale Licence (1) An operator who is
required by these rule to be licenced shall apply in writing to the Competent Authority for the grant
of a registration / licence and shall provide the following information:-

                   (a) the full name, private and business address of the applicant;
                   (b) each activity to which the application relates;
                   (c) if the applicant is a company, the full name and residential address of each
                       director and secretary of the company,
                   (d) if the applicant proposes to engage in the activity under business name, that
                       name;
                   (e) the address of each-

                      ii.                         place where the proposed activity would be carried out; and
                     iii.           premises where the drug of abuse, would be stored;

                   (f) the security arrangements that would be implemented at each address;
                   (g) the name, residential address and qualification of each person under whose
                       supervision the activity would be carried out; and
                   (h) such other particulars as may be prescribed

             (1)          An application for licence shall be accompanied by-


                        (a)     a plan of each of the relevant premises, indicating where the drug of abuse would be stored, and the
                                location and nature of any security devices: and
                        (b) the prescribed fee of Rs. 10,000/- .

3.           Undertaking for the Grant Registration / licence.- Where an application has been made in
accordance with rule 8, the Competent Authority may grant the registration/ licence if it is satisfied
that-
             (a)          The applicant and, if a company, each director and secretary of the
                          company-

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                   (i) has never been convicted in Pakistan or elsewhere of any serious
                       offence, or any offence, relation to drug of abuse controlled chemical or
                       item of controlled equipment or controlled material; and

                   (ii) is otherwise a fit and proper person to hold a licence;


             (b)        the applicant proposes to engage in the activity;
             (c)        all places and premises at or in which the activity is to be undertaken arej
                        in fit condition and appropriate.
             (d)        The security arrangements and devices proposed at each relevant place and
                        premises are appropriate and sufficient;
             (e)        The activity shall at all times be carried out under the supervision of a
                        person who is a fit and proper person to carry out that supervision; and
             (f)        Where the activity relates to drugs of abuse, the activity shall be carried out
                        exclusively for medical purposes.

4.           Contents and conditions of licences: (1) A licence issued by the Competent Authority
under rules 9 shall specify-

             (a) the full name and address of the licensee;
             (b) each activity to which the licence relates;
                 the address of each place and premises at which the licensed activity is to be
                 carried out.
             (c) such terms and conditions as are necessary and reasonable ensuring the
                 proper-

                          (i)          carrying out and supervision of the licensed activity;

                          (ii)         establishment, maintenance and preservation of record relation to
                                       that activity;

                          (iii)        Reporting to the Monitoring Committee in relation to the carrying
                                       out of that activity.

                          (iv)         Maintenance and security of all places and premises at or in which
                                       the licensed activity will be carried out;

             (d) Such other particulars as the Monitoring Committee                     may, be order in
                 writhing, require.

5.           Application for import, export or transit permits:- (1) An application for an import,
export or transit permit shall be made in writing to Federal Monitoring Committee specifying
therein:-

             (a)       the full name and address of the importer, exporter, carrier consignee and, if
                       known, of any ultimate consignee;

             (b)       in the case of proposed import, export or transit of a drug of abuse-
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                       i.               its international non-proprietary name or failing this, its name as
                                       listed in Schedule II or III, together with its trade name, if it has
                                       one; and

                      ii.              its pharmaceutical form;

             (c)       in the case of proposed export of a drug of abuse, the intended point of entry
                       in the foreign State of intended import;

             (d)       the quantity, mass and volume or percent in mixture of any drug of abuse or
                       controlled substance, that is the subject of the proposed operation;

             (e)       the date , or period within which, the planed import, export or transit is to
                       take place;

             (f)       the planed transport route, if known, including the planned point of entry or
                       exit from Pakistan; and

             (g)       in the case of a proposed import of a drug of abuse to a bonded warehouse,
                       the identity and address of the warehouse.


       2)       In the case of a proposed export of a drug of abuse, the import permit, y whatever name
described, issued by the Government of the foreign State of intended import shall be attached to
the application for export permit.

 6.          Grant of import, export or transit permits:- (1) The Competent Authority may, on
written application made in accordance with Rule 11 by a registered or licensed importer or
licensed exporter, grant an import permit, export permit, or transit permit as the case may e in
relation to a specified import or export transaction involving a drug of abuse or controlled
substance .

            (2)        An import; permit, export permit or transit permit granted under Sub-Rule (1) may
allow import, export, or transit in more than one consignment.



         (3)          An import permit, export permit or transit permit shall specify-


                      (a)              the full name and address of the registered or licensed operator to
                                       whom it is granted;

                      (b)              the name name, including any international non-proprietary name
                                       and trade name, quantity and form of any drug of abuse or
                                       controlled substance for which it is granted;
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                      (c)              in the case of an import permit-


                                 (i) The name and address of the exporter; and

                                 (ii) Whether the import is to be effected in a single consignment or
                                      more than one consignment.

                      (d)                  In the case of an export permit-

                                 (i) The name and address of the immediate consignee, and if known, of the
                                     ultimate consignee;

                                 (ii) The number and date of any required import permit, affirming that the
                                      import of the drug of abuse or preparation has been authorized;
                                 (iii) The intended point of entry in the foreign State of import ; and
                                 (iv) If the export consignment is intended for a bonded warehouse and is
                                      not prohibited under su-rule (3) that the consignment is to be so exported;

                           (e)      The period during which import or export is to be made:


                          (f)       Such terms and conditions as the Monitoring Committee may
                                    consider necessary and reasonable: and

                          (g)       Such other particulars as the Monitoring Committee may e order in
                                    writing, require.


7.           Open Individual Authorization For Certain Exports Of Controlled Substances; (1)
Where an operator is required under Rule 5 sub-rule (1) to hold an open individual authorization
issued y the competent authority, the operator shall, before undertaking any activity for which
the authorization is required/ within ten days from the day on which these rules come into force
intimate the Monitoring Committee in writing of, stating therein-

             (a)          The full name, private and business address of the operator;

             (b)          The activity for which authorization is sought;

             (c)          If the operator is a company, the full name and residential address of each director
                          and secretary of the company;

             (d)          If the operator engages in the activity under a business name, that name;

             (e)          Each controlled chemical or item of controlled equipment of material for which
                          authorization is sought;

             (f)          Such other particulars as may e prescribed.
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      (2) Subject to sub-rule (3), on receipt of an application made I n accordance with sub-rule(1),
                 the Monitoring Committee may-


                   (c) Grant an open individual authorization; and

                   (d) Subject the authorization to such terms and conditions as it thinks fit.

             (2) The Monitoring Committee may refuse to grant the open individual authorization, if the
                 operator, or if a Company, any director or secretary of the company has ever;-


                   (e) Failed to comply with a provision of these rules or any other law in Pakistan
                       relating to any drug of abuse, controlled chemical or item of controlled
                       equipment or material; or

                   (f)      Been convicted in Pakistan or elsewhere of any serious offence of any offence
                            relating to trafficking in drugs, or controlled chemicals, equipment or material.

8.      Extended authorization for related activities;- Where a person is registered or licenced,
or holds a ;permit or authorization under these rules in relation to any activity, the person shall,
subject to these rules and to any terms or conditions of the licence, permit or authorization , e
deemed to be entitled to possess the relevant drug of abuse, analogue, controlled chemical or
item of controlled equipment or material for the purpose of that activity.

9.           Duration of registration. Licences, permits and open Individual authorization; (1) A
registration or licence shall remain in force for a period of two years, unless earlier surrendered,
suspended or revoked, and may successively renewed for a period of one year on application in
writing signed by the applicant and accompanied with the prescribed fee.

          (2) A permit or open individual authorization shall only remain in force for such period as
may be specified in it, which in the case of an import permit, export permit or transit permit
shall not exceed six months.



10.     Duty of authorized persons to notify material changes, etc; (1) Where, in relation to
any licence or permit granted to any person under these rules, a material change occurs in the–

                   (a)      name or address of the person, or in the case of a company, of any director or
                            secretary of the company;

                   (b)        address of the place or premises where:-

                             (i) the licensed or permitted activity is carried out; or
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                             (ii)      any drug of abuse, controlled chemical or item of controlled equipment or
                                       material is stored;

                    (c ) raw materials, or manufacturing or denaturing processes used in the licenced
                    manufacture of any drug of abuse;


             (a)      security arrangements implemented at any relevant address;

             (b)          identity of persons under whose supervision the licenced activity is carried out; or

             (c)          planed transport route, including the planned point of entry or exit from Pakistan
                            or any import , export or transit consignment for which a permit has been ranted
                            under sub-rule(1) of Rule 12:

the person shall within fourteen days of its occurrence, furnish the Competent Authority with a
written notice containing full particulars of the change, and shall return to the Compete
Authority any licence or permit issued under these rules.

       (2)    Where, in relation to any registration or open individual authorization granted to
any person under these rules, a material changes occurs in the-


             (a)      name or address of the person, or in the case of a company, of any director or
                      secretary of the company; or

              (b) address of the place or premises where-


              (a)       the registered or authorized activity is carried out; or

             (ii)     the controlled chemical, or item of controlled material of equipment is stored,

the person shall, within fourteen days of its occurrence, furnish with the Competent Authority
with a written notice containing full particulars of the change.


 11.    Variation, suspension or revocation of registration, licences permits or
authorizations;- (1) If, at any time after the grant of a licence, permit, registration or open
individual authorization, it appears to the Competent Authority that-


          (a)          it was ranted on the basis of information that was false or misleading in a material
                       particulars;

          (b)          a material change of circumstances referred to in Rule 19 has occurred since it was
                       granted, whether notified under that rule or not;

          (c)          a condition to which it was subject has not been complied with; or

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          (d)          the person has been charged or convicted of an offence against the rules, or of a
                       serious offence,

                       the competent authority may, as it thinks necessary and reasonable in all the
                       circumstances to prevent the risk of unlawful diversion;-


                          (i) impose conditions, or very any existing conditions specified in the licence,
                              permit or authorization, within twenty-eight days of the date of issue of a
                              notice of variation;

                           (ii)            suspend the registration, licence, permit or authorization for such period
                                           as the Competent Authority deems fi; or

                           (iii)           revoke the registration, lincence, permit or authorization.


   (2) Any person whose licence, permit or au theorization is suspended or revoked under sub-
rule (1) shall return it to the Competent Authority within two days after the Competent Authority
notifies the person in writing of the revocation or suspension.

Chapter 4
                                            Professional supply of Drugs of Abuse


1.      Person authorized to engage in professional supply of drugs of abuse; -(1) No person
shall engage in conduct th\at constitutes professional supply of any drug of abuse except-


              (a) a pharmacist, acting in according with the norms and standards of the pharmacy
                  profession , who supplies to another person on prescription or on requisition in the
                  ordinary course of a pharmacy business;

              (b) a person licencd under Clause (b) of sub-rule (1) of Rule 7, provided that such
                  supply at all times takes place under the immediate supervision of a pharmacist;

              (c) a practitioner who, in accordance with the norms and standards of his or her
                  profession.


              (b) Administers the drug directly to a patient or animal in the ordinary course of
                  treatment; or

          (ii) supplies the drug to a patient or for an animal in the ordinary course of treatment
from a place more than ten kilometers from the place of business of a pharmacist.




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         (2) Notwithstanding anything contained in sub-rule (1) where access to a practitioner is not
   reasonably possible y virtue of distance, the Competent without prescription, in exceptional cases
   for use by individuals in small quantities for exclusively medical purposes.


   2.           Prescriptions: (1) No person shall prescribe a drug of abuse unless that person is-


   (a)          a medical practitioner, who prescribes the drug of abuse in the ordinary course of
                treatment of another person‟s mental conditions;

(b) a dentist who prescribes the drug of abuse in the ordinary course of treatment of another
    person‟s mental condition;

(c) a veterinary surgeon, who prescribes the drug of abuse in the ordinary course of treatment of an
    animal; or

(d) a person or class of persons which the competent authority may authorize, from time to time, for
    the purposes of this rule to prescribe certain drugs of abuse I n places where access to
    ;practitioner is not reasonably possible.

(2) A person referred to in sub-rule (1) shall not, except in-

(a) a medical emergency; or

(b) in the ordinary course of treatment,

Prescribe a drug of ause to a person who, he has reason to believe may be a drug dependent person,
without the prior written approval of the Competent Authority.


   (3) Subject to sub-rule (4), a prescription for a drug of abuse shall.

   (a)      be on a form prescribed by the Competent Authority;

         (b) be legible;

         (c) be written in terms and symbols used I n ordinary professional practice;

         (d) specify the name, address qualifications and registration number of the prescribing
             practitioner;

         (e) specify the date on which it is issued if different from the date on which it was signed,
             and the period during which it may be filled;

         (f)      specify the name and address of the patient, or the owner of animal being treated, as the
                  case may be;

         (g) specify the name, quantity, form and strength of the drug of abuse;


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                                                         28
       (h) specify the number of times u;p to a maximum of three time, the dru of abuse may be
           refilled and, if more then once, than the interval to elapse between dispensing;
       (i) if the prescription is for an unusual or dangerous dose, it shall ear the initials of the
           prescribing practitioner beside an underlined reference to the dose;
       (j) if the prescription is issued by a veterinary surgeon;-

             (a)        be endorsed as being for the treatment of an animal;

              (ii)      specify the name and address of the owner or caretaker of the animal;

                                     (iii)   specify the species of animal;
                                     (iv)    specify means of identifying the animal; and

 (k) be signed with date by the prescribing practitioner.

    (4) Where the need for treatment is urgent, a prescription may be given orally and acted
 upon, ;provided that it is confirmed by a written prescription within twenty-four hours.

 3.      Requisitions in an institution for purpose of treatment; (1) No person shall issue a
 requisition for a drug of abuse unless the person is-

       (a) a pharmacist in a dispensary in an institution;

       (b) a practitioner practicing I n an institution; of

      (c) a person in chare of a ward in an institution;
(2) A person shall not supply a drug of abuse against a requisition, except to a person referred to
in sub-rule (1) at an institution for the treatment of a person therein.

               (3) Subject to su-rule (4) , a requisition for a drug of abuse shall-

                (a) be legible;

                (b) specify the name of the person issuing it and the capacity in which he or she issues
                    it:

                (c) specify the name, quantity, form and strength of the drug of abuse;

                (d) specify the ward of dispensary where the drug is required;

                (e) be singed with date by the;

                (f) e countersigned by either the pharmacist who is to supply the drug of abuse, or a
                    medical practitioner.

        (4) Where the need for the drug of abuse is urgent, a requisition may be given orally and
 acted upon, provided that, it is confirmed by a written requisition within twenty four hours.




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                                                         Chapter- 5
                                           Commercial Documentation And Labelling,
                                                   Records And Security


4..     Commercial documents:- Any commercial document, such as an invoice, cargo
manifest or a customs, transport and other shipping document, relating to any transaction by an
operator involving a drug of abuse, controlled chemical or item of controlled equipment, shall
include;-

          (a) the name and quantity of the drug of abuse, controlled chemical or item of controlled
              equipment as specified in the relevant Schedule; and

          (b) in the case of any import or export, the name and address of the exporter, the importer
              and, where known, the consignee.

5.      Forwarding of import permit I n advance to proposed foreign exporter:- Where the
Competent Authority issues an import permit under these rules to an operator, the operator shall,
as soon as possible u no later than five working days after is receipt, forward the permit to the
exporter named in the permit.
6.      Export permits to be attached to consignments:- Where the Competent Authority
issues an export permit under these rules to an operator, the operator shall attach an authenticated
copy of the permit to each consignment on export.

7.     Endorsement and return of export permits following import:- After an imported
consignment has entered Pakistan or when the period stipulated in the import permit-expires, the
Competent Authority shall cause the export permit issued by the competent authority of the
exporting country or territory to be returned to that authority, with an endorsement specifying the
quantity of each drug of abuse or controlled chemical, equipment or material actually imported;

8. Liability to forfeiture of improperly or undocumented consignments: (1) A consignment
of a drug of abuse or controlled chemical equipment or material is liable to forfeiture if:

         (a) It is accompanied by an export permit or redirection permit, and there are reasonable
             rounds to believe that the permit is false, or has been obtained by fraud or willful
             misrepresentation of a material particular;

         (b) there are reasonable rounds to believe that an import permit relating to it is false: or

         (c) in the case of a consignment of a drug of abuse, it is not accompanied by any export o
             redirection permit.

(2) Where the Competent Authority is satisfied that any consignment referred to in sub-rule
(1) is legitimate, the consignment shall be released forthwith to the person lawful entitled to it.

9. Processing or alteration or packing:- No consignment of drug of abuse, or controlled
chemicals, equipment and material while in transit or while stored in a bounded warehouse, shall
e subjected to any process which would change the nature of the drugs, nor shall the packing of
any such consignment be altered without the permission, in writhing of the Competent
Authority.

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10. Drugs of abuse registers: (1) The following persons shall keep, or cause to be kept, at a
place where any drug of abuse is kept, a Register in the manner determined, from time to time,
by the Competent Authority:-

          (a) any person granted registration, or a licence or a permit under these rules in relation
              to any drug of abuse.

          (b) any person authorized under these rules to issue a prescription or requisition for a drug
              of abuse, or to supply such a drug by retail:

          (c) any pharmacist, including a pharmacist responsible for the supervision of all other
              pharmacists employed in a hospital or other institution for medical treatment or care:
              and

          (d) any duly qualified person, for the time being in-charge of ward or other area of an
              institution in which any drug of abuse is administered;

    (2) A person required by sub-rule (1) to keep, or cause to be kept, a register in relation to any
drug of abuse, shall within twenty-four hours of any import, export, manufacture,
administration, supply, acquisition, disposal or return of such drug enter or cause to be entered
in the register:-

              (a)       the date of import, export, manufacture, administration, supply, acquisition,
                        disposal or return;

              (b)       the name, quantity, dosage, form and strength of the drug, imported, exported,
                        manufactured, administered, supplied, acquired, disposal of or returned;

              (c)       the name and occupational or business address of person to or from whom the dru
                        w as imported, exported, supplied or acquired;

              (d)       in case of export or supply, the quantity of the drug, if any, still kept;

              (e)       in case of supply on prescription for the purpose of treatment, or of administration
                        of a drug of abuse for that purpose;

                          (i) he name and address of the person who prescribed the drug or ordered its
                              administration;

                           (ii)            the name and residential address of the person for whom or to whom the
                                           drug was supplied or administered, or where prescribed or administered
                                           to an animal, the name of the person having custody of the animal at the
                                           time;

                           (iii)           the name and residential address of the patient to whom t he drug w as
                                           prescribed, if different from the person referred to in sub-clause (ii); and

                           (iv)            where applicable, the name and address of any person other than the
                                           treating practitioner who administered the drug, the time of
                                           administration, and particulars sufficient to identify any animal for whose
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                                                                    31
                                           treatment the drug was administered, prescribed or supplied on
                                           prescription;

              (f)       in the case of supply on requisition in an institution, details of the dispensary, ward
                        or other place to which the drug was supplied;

              (g)       in the case of return, the name of the person to whom the drug w as returned: and

              (h)       in the case of disposal:-

                          (i)          the method of disposal: and

                              the signature, name and designation of the person responsible for the
                           (ii)
                              disposal, and of t least one witness to the disposal.
        (3)         A person who makes an entry in a drugs register shall sign the entry with date.


      (4) A person may, in the presence of a witness, correct, by notation, a mistake in an entry
in a drugs register, provided the person making the correction makes, sins and dates the
notation, and the witness countersign the notation.

         (5) Any person who:-

         (a)        delivers a drug of abuse to a ward or other area of an institution; or

         (b)        in the ordinary course of duties in a medical, dental or veterinary practice, or in a
                    ward or other area of an institution witnesses the administration of that drug.

Shall countersign the relevant entry in the drug register.

   (6) Any person required by these rules to keep a drug of abuse register shall, subject to any
                  written direction to the said person y the Competent Authority, retain
                  possession of t he register and all prescriptions, requisitions and commercial
                  documents relating to entries therein fo4 three years after the date of the last
                  entry in the register.


11. False or misleading entries in register and record: - Any person required to keep a
register or other record under these rules shall not


         (a) make, or cause of permit to be made, an entry which is, to the knowledge of that
             person a false or misleading in any material particulars: or

         (b) cancel, obliterate or alter any entry, except to correct an error in accordance with sub-
             rule (4) of Rule 38.

12. Duty to report and record loss, destruction or discrepancies in registers:- Any person,
required to keep a register under these rules, shall forthwith:-


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                                                                  32
            (a) report the loss or destruction of the register, or of the whole or any part of the
                contents of the register: or

            (b) record any discrepancy in the register, other than a mistaken entry, and shall report
                to the Competent Authority in writing accordingly within 24 hours.

            (c) Report of loss or theft shall also be registered with the local Law Enforcement
                Authorities.


13.      Safe keeping of drugs of abuse:- (1) Any person authorized:-


         (a) to import, export, manufacture, administer, supply or acquire a drug of abuse or
             controlled chemical in accordance with these rules: or

          (b) to engage in professional supply in accordance with Rule 23:

shall, while the drug or chemical is in the person‟s custody or control, keep I or cause to be kept
vault, safe or other prescribed secure storage.


    (2) A ;person, referred to in sub-rule (1) , shall take such measures as the Competent
Authority may direct, in writing, to ensure that no unauthorized person has:


          (a) Access to the combination, key or other means of access to any secure receptacle
              containing a drug of abuse or controlled chemical: or

          (b) the drug or chemical contained therein.

14. Duties where there is loss or theft of a drug of abuse or controlled chemical:- Any
person authorized:-

       (a) to import, export, manufacture, administer, supply or acquire a dru of abuse or
           controlled chemical in accordance with these rules: or

       (b) to engage in ;professional supply in accordance with Rules 23:

    shall, immediately upon becoming aware of the loss or theft of any quantity of the drug or
chemical in the person‟s custody or control shall:

              (j)       if the person believes on reasonable rounds that the drug or chemical has been
                        stolen, he shall immediately inform an Inspector and an authorized officer orally,
                        and report the matter in within twenty-four hours:

                           (ii)            in the case of loss, give a written report of the circumstances of the loss to
                                           an inspector: and

                           (iii)           record relevant particulars of the loss of theft in the appropriate register.

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                                                                     33
                           (iv)            Complete report should be forwarded to the Competent Authority within
                                           24 hours.

CHAPTER 6

         Inspection For Compliance

1.    Power of Inspectors: (1) A person appointed as an Inspector by the Competent Authority
pursuant to Rule 44 may, at any time during ordinary business or professional hours, with such
assistance and by such force as is necessary and reasonable, enter any premises or place at which
any activity is carried out by any person who has been;-

         (a) granted a registration, licence or permit under these rules, or

         (b) authorized in accordance with Rule 23 to engage in professional supply.

         (2)       Subject to Rule 47, an inspector who enters any premises or place pursuant to
         sub-rule (1) may:-

          (a) require the occupier of the premises to supply his or her name and address:

          (b) inspect the premises or place in order to ascertain whether or not the rules or terms or
              conditions of any licence or permit granted pursuant to the rules has been or is being
              complied with.

          (c) Examine any label, advertising material, register, record, book, electronic data or other
              document therein relating to any drug of abuse, controlled chemical or item of
              controlled equipment or material:

          (d) Make an extract, there from or take a copy thereof, and require from any person an
              explanation of an entry in any such register, record or document.

          (e) Open and examine any receptacle or package found in that place in which a drug of
              abuse, analogue, controlled chemical or item of controlled equipment may be found:

          (f) Examine any think found in that place that is used or may e capable of being used for
              the manufacture, packaging or storage of a drug of abuse alaloue, controlled chemical
              or item of controlled equipment or material;

          (g) Use or cause to e used any computer system at that place to examine any electronic
              data referred to in clause (C) or (f) , and reproduce any document from any such data
              or cause it to be reproduced in the form of a printout or other putput;

          (h) Take anything referred to in clause (C) or (f) for examination or copying;

          (i) Use or cause to be used any copying equipment at that place to make copies of any
              document

          (j) Examine any substance found in that place and take, for the purpose of analysis, such
              samples thereof as are reasonably required;

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                                                                  34
          (k) Seize and detain anything, which in the opinion of the inspector, is connected with, or
              may provide proof of a contravention of the rules or a term or condition of any licence
              or permit ranted under the rules and which the Inspector believes on reasonable rounds
              in necessary for the purpose of ensuring compliant with the rules or the regulations.


      (3)         Where an Inspector seizes and detains any substance suspected to be a drug of
      abuse, analogue, controlled chemical or item of controlled equipment or material, he may, at
      his discretion, be kept or stored at the place from where it was seized or be removed to any
      other proper place.

      4)          Where an inspector determines that for the purpose of ensuring compliance with
      these rules, it is no longer necessary to detain a substance suspected to be a dru of abuse,
      controlled chemical or item of controlled equipment or material under clauses (j), (k) of
      Sub-rule(2) , the Inspector shall notify in writing to be owner or other person in charge of
      the place where it was detained of that determination and, on being issued a receipt thereof
      shall return the substance to that person.


5)           Wherein in the ordinary course of duty, an inspector becomes aware of a possible
offence against the Act, he or she shall immediately report that fact to the Anti Narcotics force
and provide such further lawful assistance as may be reasonable or necessary for the purpose of
any investigation or proceeding relating to the possible offence.


2.   Obstruction of Inspectors, etc:- No person, shall without reasonable excuse, by an act or
omission;


          (c) obstruct or hinder an Inspector in the exercise of the powers or performance of the
              duties of the Inspector under these rules or regulations: or

         (c) refuse or fail to comply with a reasonably request of an Inspector who has entered any
             premises in accordance with these rules;

Chapter 7

(1)      Accountability:

      The following minor and major and major punishment shall e awarded to the officers and
member s of staff of the Federal or Provincial agencies involved in regulation of drugs of abuse
or substances, namely;-

         (a) Minor Punishment;

            (b)       Censure:

                      (ii)             forfeiture of approved service up to two years;

                      (iii)            withholding of promotion up to one year;

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                                                                35
                      (iv)             stoppage of increment of a period not exceeding three years without
                                       cumulative effect;

                      (v)              fine to any amount not exceeding one months pay;

(b) Major Punishments:

      (a) reduction in rank;
                      (v)    compulsory retirement;
                      (vi)   removal from service; and
                      (vii) dismissal from service.

(c)      Grounds of punishment, Where, a officer and official, in the opinion of the Authority.

             (a)    is inefficient or has ceased to be efficient: or
             (b)    is guilty of misconduct; or
             (c)    is corrupt or may reasonably be considered corrupt; or
             (d)    is failed to perform is duties under these rules;

(2)      User Accountability As Awareness Programs:

         a)               The purpose of user accountability is to not only make the public aware of the
                          Federal Government‟s position on drug abuse, but to describe new programs
                          intended to decrease drug abuse by holding drug abusers personally responsible
                          for their illegal activities, and imposing civil penalties on those who violate drug
                          laws.
         b)               It is important to remember that these penalties are in addition to the criminal
                          penalties drug abusers are already given, and do not replace those criminal
                          penalties.

         c)               The new ser accountability programs call for more instruction in schools,
                          kindergarten through senior high, to educate children on the dangers of drug
                          abuse. These programs will include participation by students, parents, teachers
                          local businesses and the local, state and Federal Government.

         d)               User accountability also gargets businesses interested in doing business with the
                          Federal Government. This program requires those businesses to maintain a drug-
                          free workplace, principally through educating employees on the dangers of drug
                          abuse, and by informing employees of the penalties they face if they engage in
                          illegal drug activity on company property.

CHAPTER 8

MONITORING AND REPORTING


1.       Monitoring Committees:                      (1)    Federal & Provincial Governments shall constitute
monitoring committees for monitoring and checking of business of drugs of abuse and
substances.
         (2)              Federal monitoring committee shall consist of following members:-
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                                                        36
         a)               Drugs Controller (Registration) who shall be ex-officio Chairperson.
         b)               One expert from the field of Psychiatry to be nominated by Federal Government.
         c)               Secretary Provincial Quality Control Board of each Province.
         d)               A representative of Drugs Manufacturers Associations.
         e)               A representative of the Pakistan Medical Association (PMA)
         f)               A representative of the Anti-Narcotic Force.
         g)               DDG Registration who shall be Secretary of the Committee.

              (3)         Competent Authority shall consist of following members:-.

                          a)        Additional Secretary Technical who shall be ex-officio Chairperson.
                          b)          Chief Drug Inspector who shall be ex-officio Secretary of the
                                     Committee
                          c)         Incharge Drug Control Organization.          Member
                          d)         One Representative from Pakistan Manufacturers Associations to
                                     be nominated by Provincial Government
                          e)         One Representative Pakistan Chemists and Druggist Association
                                     (PCDA) to be nominated by Provincial Government
                          f)         One Representative of the Pakistan Medical Association to be
                                     nominated by Provincial Government
                          g)         One representative of Anti-Narcotic Force.

              (4)     Federal Monitoring Committee shall maintain a data base for the
              registered drugs, quotas and authorization issued in this behalf and other data
              received from various relevant quarters.

              (5)         Federal Inspector of Drugs, Assistant Drugs Controller and manufacturers
              shall refer monthly reports for the manufacturing and sale of drugs of abuse to the
              Federal Monitoring committee.


              (6)         Competent Authority shall submit consolidated monthly reports received
              from the Provincial Inspectors and Licensed Pharmacies including distributors
              dealing with the drugs of abuse.


              (7)         Area Inspectors of Provincial and Federal Governments shall submit
              consolidated monthly reports for sale and manufacturing of drugs of abuse to the
              concerned committees.


              (8)         Operators dealing with the drugs of abuse and substances shall submit
              monthly reports to the concerned Provincial or Federal Inspectors as the case may
              be.
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                                                             37
             (9)          Both Monitoring Committees shall cause complete audit of at least two
             cases in depth on annual basis.
             (10)         Provincial or Federal Monitoring Committees may give recommendations
             about the discrepancies identified by them to the Provincial Quality Control
             Board or Drugs Registration Board or Provincial & Federal Competent
             Authorities stating the reasons and justifications.
             (11)         Monitoring Committee may recommend the cancellation of licences or
             registrations of operators as the case may be.


             (12)         A competent authority shall investigate the cases referred by monitoring
             committee and proceed actions as provided in these rules.
             (13)         Monitoring Committees shall meet at least on quarterly basis and review
the compliance to these rules in their respective jurisdiction.
             (14)         Competent Authority may notify the mis-users and abusers of these drugs
and shall maintain their records.


2.           Sale Of Drugs Of Abuse:           (1)    Sale of drugs of abuse shall be conducted on
red colour invoices which shall be exclusively use for these drugs. The operator shall
endorse one copy to the Area Inspector.
             (2)          The payment of invoices shall be made through drafts only and record
shall be maintained.


             (3)          Documentation of records along with traceability shall be maintained by
the operators.


             (4)          Sale of drugs of abuse shall be restricted only to the licencees having
transparent system for maintaining the record and have properly trained pharmacists to
supervise the sales of these drugs.




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                                                         38
                                  PURCHASE ORDER AND SUPPLY FORM FOR SCHEDULE II & SCHEDULE III DRUGS OF ABUSE


                  See Reverse of Purchaser‟s                  No order form may be issued for schedule II & III substances unless a         Drugs Registration No.
                     Copy for instructions                              completed application form has been received ( )
                 To: (Name of Supplier)                                                        Street Address

                 City and State                                                      Date                                          To be filled in by supplier
                                                                                                                       Suppliers Invoice No.
                 Line No.                                   To be Filled in by Purchaser
                                       No. of       Size of             Name of Item                   Remarks for Any Change in the Order         Packages        Date
                                      Packages      Package                                                                                        Supplied      Supplied
                 1
                 2
                 3
                 4
                 5
                 6
                 7
                 8
                 9
                 10
                                                                                                          Signature of the Supplier

                                                  Last line                                    Signature of purchaser
                                                 Completed             (MUST BE 10 OR LESS)
                 Date Issued                                      Purchaser Licence No. Name and address of Purcahser




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                                                                                                39
                                                  PRESCRIPTION FROM
                               (Must Be Filled In By The Prescriber In His Own Hand Writing)
                                                                                             Date:


1.      Name and Address of the
        Prescribe along with title:

2.      Name of Patient:                                                                       Age:


3.      Address of the Patient                                                                 Sex:

                                                                                                Male:
                                                                                                Female:

        Disease:

4.      Name of Drug along with
        strength and interval for use:

5       Total quantity of the drug to
        be dispensed:


        PMDC Registration No:__________________                                       ___________________
                                                                                     Signature of the Prescriber




     Decision:                 The draft was transferred to the members for detailed study and policy was
     deferred till forth coming meeting of CL & RB.




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                                                               40
         ITEM NO. 4

         NEW APPLICATIONS FOR REGISTRATION OF CONTRACT                                  MANUFACTURING

S. No.    Name of firm                  Name of Drugs & Composition       Pack      Demanded            Decision
                                                                          Size         Price
   1.      M/s. Olive                   Cefolive 500mg IV/IM Injection   Per vial     As per       Approved subject
          Laboratories,                 Each vial contains:-                        Govt. Policy   to confirmation of
              Rawat,                    Ceftraxone…………….500mg                        New name      renewal of licence
          Manufactured                  As Ceftriaxone Sodium                        Trivolive     and        HVAC
           by Global                    (Cephalosporin)                                            system.
         Pharmaceutical
          s, Islamabad                                                                             2. Grant of toll
                                                                                                   manufacturing
                                                                                                   permission may
                                                                                                   not be acceded to
                                                                                                   such firms if
                                                                                                   more than one
                                                                                                   sample is failed
                                                                                                   and       similarly
                                                                                                   contract
                                                                                                   manufacturer
                                                                                                   may      not     be
                                                                                                   allowed if any
                                                                                                   sampleis declared
                                                                                                   substandard in the
                                                                                                   relevant section
                                                                                                   dedicated       for
                                                                                                   contract
                                                                                                   manufacturing.

                                                                                                   3. Availability of
                                                                                                   M/s. Global for
                                                                                                   manufacturing 50
                                                                                                   products, if M/s.
                                                                                                   Global        have
                                                                                                   crossed the 50
                                                                                                   products limit, the
                                                                                                   manufacturer may
                                                                                                   be changed to the
                                                                                                   GMP complaint
                                                                                                   firm          after
                                                                                                   fulfillment      of
                                                                                                   requirements of
                                                                                                   contract    policy
                                                                                                   and Chairperson
                                                                                                   Registration
                                                                                                   Board             is
                                                                                                   authorized       to
                                                                                                   change          the
                                                                                                   manufacturer.
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                                                                   41
                                                                                                 Rs.170.00/Vial
                                                                                                     st
                                                                                                    1 ….43
2.          -do-          Cefolive 250mg IV/IM Injection               Per vial     As per            -do-
                          Each vial contains:-                                    Govt. Policy   Rs.101.00/vial
                          Ceftraxone…………….250mg                                    New name
                          As Ceftriaxone Sodium                                    Trivolive        1st…..42
                          (Cephalosporin)

3.          -do-          Cefolive 1.0g IV/IM Injection                Per vial     As per            -do-
                          Each vial contains:-                                    Govt. Policy   Rs. 321.00/1’s
                          Ceftraxone…………….1.0g                                     New name          st
                                                                                                    1 …..41
                          As Ceftriaxone Sodium                                    Trivolive
                          (Cephalosporin)

4.          -do-          Pimeolive 500mg IV/IM Injection              Per vial     As per            -do-
                          Each vial contains:                                     Govt. Policy         do-
                          Cefepime (as HCI)………..500mg                                             Rs.300.00/1’s
                          (Cephalosporin)
                                                                                                    6th…47
5.          -do           Pimeolive 1.0g IV/IM Injection               Per vial     As per            -do-
                          Each vial contains:                                     Govt. Policy    Rs.600.00/1’s
                          Cefepime (as HCI)………..1.0g
                          (Cephalosporin)                                                            6th…48

6.          -do-          Olitax 500mg IV/IM Injection                 Per vial      As per           -do
                          Each vial contains:                                     Govt. Policy   Rs.110.00/vial
                          Cefotaxiame (As                                          New name        5th….61
                          Sodium)……500mg                                            Taxolive
                          (Cephalosporin)

7.          -do-          Olitax 250mg IV/IM Injection                 Per vial      As per           -do-
                          Each vial contains:                                     Govt. Policy    Rs.60.00/vial
                          Cefotaxiame (As                                          New name
                          Sodium)……250mg                                            Taxolive        5th….59
                          (Cephalosporin)

8.          -do-          Olitax 1.0g IV/IM Injection                  Per vial      As per          -do-
                          Each vial contains:                                     Govt. Policy   Rs.160.00/vial
                          Cefotaxiame (As Sodium)……1.0g                            New name
                          (Cephalosporin)                                           Taxolive        5th….60

9.          -do-          Cebolive 2.0g IV/IM Injection                Per vial     As per           -do-
                          Each vial contains:                                     Govt. Policy   Rs.350.00/1‟S
                          Cefoperazone (As Sodium)…..1.0g                          New name
                          Sulbactam (As Sodium)………1.0g                             Zonectam          14TH
                          (Cephalosporin)

10.                                  Cebolive 1.0g IV/IM Injection     Per vial     As per            -do-
                                     Each vial contains:                          Govt. Policy   Rs.250.00/Vial
                                     Cefoperazone (As Sodium)..500mg               New name
                                     Sulbactam (As Sodium)……500mg                  Zonectam       14th…PRC
      bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                                 42
                                     (Cephalosporin)


11.    M/s. Unison                   Cefeson 500mg IV/IM Injection    Per vial     As per              -do-
         Chemical                    Each vial contains:                         Govt. Policy
      Works Araian-                  Cefepime HCI……………..500mg
      15 Km raiwind                  (Cephalosporin)
       Road, Lahore
       Manufactured
        by Global
      Pharmaceutical
       s, Islamabad

12.            -do-                  Cefeson 1.0g IV/IM Injection     Per vial     As per              -do-
                                     Each vial contains:                         Govt. Policy
                                     Cefepime HCI……………..1.0g
                                     (Cephalosporin)

13.            -do-                  Cefosul 2.0g IV Injection        Per vial     As per              -do
                                     Each vial contains:                         Govt. Policy
                                     Cefoperazone 9as Sodium)…1.0g
                                     Sulbactam (as Sodium)……..1.0g
                                     (Cephalosporin)

14.            -do-                  Cefosul 1.0g IV Injection        Per vial     As per              -do
                                     Each vial contains:                         Govt. Policy
                                     Cefoperazone (as Sodium)…500mg
                                     Sulbactam (as Sodium)……500mg
                                     (Cephalosporin)

15.    M/s. Navegal                  Pigmal 1.0gm IM/IV Injection     Per vial     As per     Approved subject
       Laboratories,                 Each vial contains:                         Govt. Policy to confirmation of
        41/1-A-2,                    Cefepime HCI                                             renewal of licence
          Phase-I,                   Equivalent to Cefepime                                   and        HVAC
         Industrial                  Hcl…1000mg                                               system.
       Estate Hattar.                (Cephalosporin)
       Manufactured                                                                             2. Grant of toll
       by Welward                                                                               manufacturing
      Pharmaceutical                                                                            permission may
          , Hattar.                                                                             not be acceded to
                                                                                                such firms if
                                                                                                more than one
                                                                                                sample is failed
                                                                                                and       similarly
                                                                                                contract
                                                                                                manufacturer
                                                                                                may      not    be
                                                                                                allowed if any
                                                                                                sampleis declared
                                                                                                substandard in the
                                                                                                relevant section
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                                                                43
                                                                                                 dedicated       for
                                                                                                 contract
                                                                                                 manufacturing.
                                                                                                 3. Availability of
                                                                                                 M/s. Welwrd for
                                                                                                 manufacturing 50
                                                                                                 products, if M/s.
                                                                                                 Welwrd        have
                                                                                                 crossed the 50
                                                                                                 products limit, the
                                                                                                 manufacturer may
                                                                                                 be changed to the
                                                                                                 GMP complaint
                                                                                                 firm          after
                                                                                                 fulfillment      of
                                                                                                 requirements of
                                                                                                 contract    policy
                                                                                                 and Chairperson
                                                                                                 Registration
                                                                                                 Board             is
                                                                                                 authorized       to
                                                                                                 change          the
                                                                                                 manufacturer.

16.            -do-                  Pigmal 500gm IM/IV Injection      Per vial     As per              -do-
                                     Each vial contains:                          Govt. Policy
                                     Cefepime HCI
                                     Equivalent to Cefepime
                                     Hc……………500mg
                                     (Cephalosporin)

17.            -do-                  Taxgal 1.0g Injection Im/IV       Per vial     As per              -do-
                                     Injection                                    Govt. Policy
                                     Each vial contains:
                                     Cefotaxime Sodium
                                     Equivalent to Cefotaxime…….1g
                                     (Cephalosporin)

18.            -do-                  Cefgal 1.0g IM/IV Injection       Per vial     As per              -do-
                                     Each vial contains:                          Govt. Policy
                                     Ceftriaxone Sodiumequivalent to
                                     Ceftriaxoane…………..1g
                                     (Cephalosporin)

19.            -do-                  Cefsule 2.0gm Injection IM/IV     Per vial     As per              -do-
                                     Injection                                    Govt. Policy
                                     Each vial contains:
                                     Sulbactum + Cefoperazone Sodium
                                     equivalent …………2gm
                                     (Cephalosporin)

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                                                                44
20.            -do-                  Cefsule 1.0g Injection IM/IV        Per vial     As per              -do-
                                     Injection                                      Govt. Policy
                                     Each vial contains:
                                     Sulbactum + Cefoperazone Sodium
                                     equivalent …………12g
                                     (Cephalosporin)

21.     M/s. Albro                   Trigen Im/IV Injection 250mg/vial   Per vial     As per        Rejected on the
      Pharmaceutical                 Each Vial Contains:                            Govt. Policy   grounds that M/s.
        s (Pvt) Ltd,                 Ceftriaxone Sodium                                                  Albro
          Lahore,                    Equivalent to                                                 Pharmaceutical is
       Manufactured                  Ceftriaxone……….250mg                                               GMP non
       by Welward                    (Cephalosporin)                                                compliant firm
      Pharmaceutical                                                                                  Moreover its
          , Hattar.                                                                                 licence was not
                                                                                                      renewed and
                                                                                                      More than 2
                                                                                                     samples were
                                                                                                   declared failed by
                                                                                                     Drugs Testing
                                                                                                      Laboratories.
                                                                                                    (List enclosed)

22.            -do-                  Bromine Injection 500mcg            Per vial     As per              -do-
                                     Each ampoule Contains:                         Govt. Policy
                                     Mecobalamine…………… 500mcg
                                     (Co-enzyme typ;e vitamin B 12 )

23.    M/s. Navegal                  Cefgal 250mg IM/IV Injection        Per vial     As per     Approved subject
       Laboratories,                 Each Vial Contains:                            Govt. Policy to confirmation of
        41/1-A-2,                    Ceftriaxone Sodium                                          renewal of licence
          Phase-I,                   Equivalent to                                               and        HVAC
         Industrial                  Ceftriaxone……250mg                                          system.
       Estate Hattar.                (Cephalosporin)
       Manufactured                                                                                2. Grant of toll
       by Welward                                                                                  manufacturing
      Pharmaceutical                                                                               permission may
          , Hattar.                                                                                not be acceded to
                                                                                                   such firms if
                                                                                                   more than one
                                                                                                   sample is failed
                                                                                                   and       similarly
                                                                                                   contract
                                                                                                   manufacturer
                                                                                                   may      not    be
                                                                                                   allowed if any
                                                                                                   sampleis declared
                                                                                                   substandard in the
      bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                                45
                                                                                                  relevant section
                                                                                                  dedicated      for
                                                                                                  contract
                                                                                                  manufacturing.

                                                                                                  3. Availability of
                                                                                                   M/s. Welwrd for
                                                                                                  manufacturing 50
                                                                                                   products, if M/s.
                                                                                                     Welwrd have
                                                                                                    crossed the 50
                                                                                                  products limit, the
                                                                                                  manufacturer may
                                                                                                  be changed to the
                                                                                                   GMP complaint
                                                                                                       firm after
                                                                                                     fulfillment of
                                                                                                   requirements of
                                                                                                    contract policy
                                                                                                   and Chairperson
                                                                                                      Registration
                                                                                                        Board is
                                                                                                     authorized to
                                                                                                      change the
                                                                                                    manufacturer.

24.            -do-                  Taxgal 250mg Injection IM/IV       Per vial     As per              -do-
                                     Each Vial Contains:                           Govt. Policy
                                     Cefotaxome Sodium
                                     Equivalent to Cefotaxime…..250mg
                                     (Cephalosporin)

25.          M/s                     Hycef 250mg IV/IM Injection        Per vial     As per           Board is
        Pharmacare                   Each vial Contains:                           Govt. Policy     authorized to
       Laboratories                  Ceftriaxone Sodium                                              change the
         (Pvt) Ltd,                  Equivalent to                                                  manufacturer
       Manufactured                  Ceftriaxone……250mg
      by M/s. Vision                 (Cephalosporin)
      Pharmaceutical
       s, Islamabad.




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                                                               46
26.      M/s Ipram                   Cili-Cef 400mg Tablet             As per   Approved subject
       International,                Each Tablet Contains:             Policy   to confirmation of
         Islamabd                    Cefixime Trihydrate eq. To                 renewal of licence
       Manufactured                  Cefixime……………400mg                         and        HVAC
       by M/s. M/s.                  (Cephalosporin Antibiotic)                 system.
          Navegal
       Laboratories,                                                            2. Grant of toll
         41/1-A-2,                                                              manufacturing
          Phase-I,                                                              permission may
         Industrial                                                             not be acceded to
       Estate Hattar.                                                           such firms if
                                                                                more than one
                                                                                sample is failed
                                                                                and       similarly
                                                                                contract
                                                                                manufacturer
                                                                                may      not     be
                                                                                allowed if any
                                                                                sampleis declared
                                                                                substandard in the
                                                                                relevant section
                                                                                dedicated       for
                                                                                contract
                                                                                manufacturing.

                                                                                3. Availability of
                                                                                M/s. Navegal for
                                                                                manufacturing 50
                                                                                 products, if M/s.
                                                                                   Navegal have
                                                                                  crossed the 50
                                                                                products limit, the
                                                                                manufacturer may
                                                                                be changed to the
                                                                                 GMP complaint
                                                                                     firm after
                                                                                   fulfillment of
                                                                                 requirements of
                                                                                  contract policy
                                                                                 and Chairperson
                                                                                    Registration

27.            -do-                  Cili-Cef 200mg Tablet             As per          -do-
                                     Each Tablet Contains:             Policy
                                     Cefixime Trihydrate eq. To
                                     Cefixime……………200mg
                                     (Cephalosporin Antibiotic)

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                                                                  47
28.   M/s. Ambrosia                  Ajuda Injection                    As per   Approved subject
      Pharmaceutical                 Each vial containsCefuroxime (as   Policy   to confirmation of
         s, Rawat,                   Cefuroxime Sodium)………..250mg                renewal of licence
        Islamabad.                   (Cephalosporins)                            and        HVAC
       manufactured                                                              system.
       by M/s Ipram
       International,                                                            2. Grant of toll
         Islamabd                                                                manufacturing
                                                                                 permission may
                                                                                 not be acceded to
                                                                                 such firms if
                                                                                 more than one
                                                                                 sample is failed
                                                                                 and       similarly
                                                                                 contract
                                                                                 manufacturer
                                                                                 may      not     be
                                                                                 allowed if any
                                                                                 sampleis declared
                                                                                 substandard in the
                                                                                 relevant section
                                                                                 dedicated       for
                                                                                 contract
                                                                                 manufacturing.

                                                                                 3. Availability of
                                                                                   M/s. Ipram for
                                                                                 manufacturing 50
                                                                                  products, if M/s.
                                                                                     Ipram have
                                                                                   crossed the 50
                                                                                 products limit, the
                                                                                 manufacturer may
                                                                                 be changed to the
                                                                                  GMP complaint
                                                                                      firm after
                                                                                    fulfillment of
                                                                                  requirements of
                                                                                   contract policy
                                                                                  and Chairperson
                                                                                     Registration

29.            -do-                  Grcon Injection                    As per          -do-
                                     Each Vial contains:                Policy
                                     Ceftriaxone
                                     (as Ceftriaxone Sodium)..250mg
                                     (Cephalosporins)

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                                                                48
30.            -do-                  Tilit Injection                    As per   -do-
                                     Each vial contains:                Policy
                                     Cefotaxime
                                     (as Cefotaxime Sodium)..250mg
                                     (Cephalosporins

31.            -do-                  Grcon Injection                    As per   -do-
                                     Each Vial contains:                Policy
                                     Ceftriaxone
                                     (as Ceftriaxone Sodium)..1g
                                     (Cephalosporins)

32.            -do-                  Tilit Injection                    As per   -do-
                                     Each vial contains:                Policy
                                     Cefotaxime
                                     (as Cefotaxime Sodium)……500mg
                                     (Cephalosporins

33.            -do-                  Grcon Injection                    As per   -do-
                                     Each Vial contains:                Policy
                                     Ceftriaxone
                                     (as Ceftriaxone Sodium)……500mg
                                     (Cephalosporins)

34.            -do-                  Tilit Injection                    As per   -do-
                                     Each vial contains:                Policy
                                     Cefotaxime
                                     (as Cefotaxime Sodium)……..1g
                                     (Cephalosporins

35.            -do-                  Ajuda Injection                    As per   -do-
                                     Each vial containsCefuroxime (as   Policy
                                     Cefuroxime Sodium)……….750mg
                                     (Cephalosporin)




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                                                                   49
36.     M/s Shazal                   Zeldin Injection 250mg IM/IV      As per   Approved subject
      Pharmaceutical                 Each vial contains:               Policy   to confirmation of
         s, Hattar                   Cephradine Sterile As L-                   renewal of licence
       manufactured                  Arginine…250mg.                            and        HVAC
         by M/s.                     (Cephalosporin)                            system.
        Welward
      Pharmaceutical                                                            2. Grant of toll
         , Hattar.                                                              manufacturing
                                                                                permission may
                                                                                not be acceded to
                                                                                such firms if
                                                                                more than one
                                                                                sample is failed
                                                                                and       similarly
                                                                                contract
                                                                                manufacturer
                                                                                may      not     be
                                                                                allowed if any
                                                                                sampleis declared
                                                                                substandard in the
                                                                                relevant section
                                                                                dedicated       for
                                                                                contract
                                                                                manufacturing.

                                                                                3. Availability of
                                                                                M/s. Welwrd for
                                                                                manufacturing 50
                                                                                products, if M/s.
                                                                                Welwrd        have
                                                                                crossed the 50
                                                                                products limit, the
                                                                                manufacturer may
                                                                                be changed to the
                                                                                GMP complaint
                                                                                firm          after
                                                                                fulfillment      of
                                                                                requirements of
                                                                                contract    policy
                                                                                and Chairperson
                                                                                Registration

37.            -do-                  Zeldin Injection 1gm IM/IV        As per          -do-
                                     Each vial contains:               Policy
                                     Cephradine Sterile As L-
                                     Arginine…1.0gm.
                                     (Cephalosporin)

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                                                                  50
38.             -do-                  Zeldin Injection 500mg IM/IV      As per          -do-
                                      Each vial contains:               Policy
                                      Cephradine Sterile As L-
                                      Arginine………………….500mg.
                                      (Cephalosporin)

39.             -do-                  Zelrome Injection 1 gm IM/IV      As per          -do-
                                      Each vial contains:               Policy
                                      Cefpirome as Sulphate
                                      equivalent ………….1.gm
                                      (Cephalosporin)

40.             -do-                  Zelbactum 1.0gm Injection IM/IV   As per          -do-
                                      Each vial contains:               Policy
                                      Sulbactum+cefop;erazone sodium
                                      equivalent……1 gm.
                                      (Cephalosporin)

41.             -do-                  Zelrome Injection 500mg IM/IV     As per          -do-
                                      Each vial contains:               Policy
                                      Cefpirome as Sulphate
                                      equivalent ………..500mg
                                      (Cephalosporin)

42.    M/s. Welward                   Welexime 100mg/5ml Dry            As per   Approved subject
      Pharmaceuticals,                Sspension                         Policy   to confirmation of
            Hattar,                   Each 5ml contains:                         renewal of licence
       Manufactured                   Cefixime………………..100mg                      and        HVAC
         by Navegal                   (Cephalosporin Antibiotic)                 system.
        Laboratories,
      41/1-A-2, Phase-                                                           2. Grant of toll
         I, Industrial                                                           manufacturing
       Estate Hattar..                                                           permission may
                                                                                 not be acceded to
                                                                                 such firms if
                                                                                 more than one
                                                                                 sample is failed
                                                                                 and       similarly
                                                                                 contract
                                                                                 manufacturer
                                                                                 may      not     be
                                                                                 allowed if any
                                                                                 sampleis declared
                                                                                 substandard in the
                                                                                 relevant section
                                                                                 dedicated       for
                                                                                 contract
                                                                                 manufacturing.
       bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                                51
                                                                                        3. Availability of
                                                                                        M/s. Navegal for
                                                                                        manufacturing 50
                                                                                        products, if M/s.
                                                                                        Navegal       have
                                                                                        crossed the 50
                                                                                        products limit, the
                                                                                        manufacturer may
                                                                                        be changed to the
                                                                                        GMP complaint
                                                                                        firm          after
                                                                                        fulfillment      of
                                                                                        requirements of
                                                                                        contract    policy
                                                                                        and Chairperson
                                                                                        Registration

43.     M/s. Albro                   Trixime 250mg Injection IM/IV            As per    Rejected on the
      Pharmaceutical                 Injection                                Policy    grounds that M/s.
        s (Pvt) Ltd,                 Each Vial Contains:                                Albro
       Manufactured                  Cefotaxime Sodium equivalent to                    Pharmaceutical is
          by M/s.                    Cefotaxime………………250mg                              GMP             non
         Welward                     (Cephalosporin)                                    compliant      firm
      Pharmaceutical                                                                    Moreover         its
         s, Hattar,                                                                     licence was not
                                                                                        renewed and
                                                                                        More than 2
                                                                                        samples       were
                                                                                        declared failed by
                                                                                        Drugs       Testing
                                                                                        Laboratories.
                                                                                          (List enclosed)

44.    M/s Medisure                  Fincef 250mg IV Injections        1‟s   New name   Approved subject
       Labs, Karachi                 Each vial contains:-                    Armasure   to confirmation of
       manufactured                  Ceftiraxone Sodium (as                             renewal of licence
         by M/s.                     Sodium)…250mg                                      and        HVAC
        PharmEvo,                                                                       system.
         Karachi
                                                                                        2. Grant of toll
                                                                                        manufacturing
                                                                                        permission may
                                                                                        not be acceded to
                                                                                        such firms if
                                                                                        more than one
                                                                                        sample is failed
                                                                                        and       similarly
                                                                                        contract
                                                                                        manufacturer
                                                                                        may      not    be
      bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                                  52
                                                                                           allowed if any
                                                                                           sampleis declared
                                                                                           substandard in the
                                                                                           relevant section
                                                                                           dedicated      for
                                                                                           contract
                                                                                           manufacturing.

                                                                                           3. Availability of
                                                                                           M/s. PharmEvo
                                                                                           for manufacturing
                                                                                           50 products, if
                                                                                           M/s. PharmEvo
                                                                                           have crossed the
                                                                                           50 products limit,
                                                                                           the manufacturer
                                                                                           may be changed
                                                                                           to   the     GMP
                                                                                           complaint     firm
                                                                                           after fulfillment
                                                                                           of requirements
                                                                                           of contract policy
                                                                                           and Chairperson
                                                                                           Registration

                                                                                            Rs.101.00/Vial

                                                                                                1st….42

45.            -do-                  Fincef 500mg IV Injections         1‟s   New name           -do-
                                     Each vial contains:-                     Armasure      Rs.170.00/Vial
                                     Ceftiraxone Sodium (as
                                     Sodium)…500mg                                              1st….43

46.            -do-                  Fincef 1g IV Injections            1‟s   New name           -do-
                                     Each vial contains:-                     Armasure      Rs. 321.00/1‟s
                                     Ceftiraxone Sodium (as
                                     Sodium)…1g                                                 1st….41

47.    M/s Mediate                   Cefobactam 1gm Dry Powder          1‟s   Rs. 349.00   Approved subject
      Pharmaceutical                 Injections                                            to confirmation of
         , Karachi                   Each vial contains:-                                  renewal of licence
       manufactured                  Cefoperazone (as Sodium)...500mg                      and        HVAC
       by M/s. Uni-                  Sulbactamf (as Sodium)…500mg                          system.
      Tiech, Karachi                 (Antibiotic)
                                                                                           2. Grant of toll
                                                                                           manufacturing
                                                                                           permission may
                                                                                           not be acceded to
                                                                                           such firms if
                                                                                           more than one
      bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                                  53
                                                                                             sample is failed
                                                                                             and       similarly
                                                                                             contract
                                                                                             manufacturer
                                                                                             may      not     be
                                                                                             allowed if any
                                                                                             sampleis declared
                                                                                             substandard in the
                                                                                             relevant section
                                                                                             dedicated       for
                                                                                             contract
                                                                                             manufacturing.

                                                                                             3. Availability of
                                                                                             M/s. Uni-Tiech
                                                                                             for manufacturing
                                                                                             50 products, if
                                                                                             M/s. Uni-Tiech
                                                                                             have crossed the
                                                                                             50 products limit,
                                                                                             the manufacturer
                                                                                             may be changed
                                                                                             to   the     GMP
                                                                                             complaint     firm
                                                                                             after fulfillment
                                                                                             of requirements
                                                                                             of contract policy
                                                                                             and Chairperson
                                                                                             Registration

48.            -do-                  Cefobactam 2gm Dry Powder           1‟s    Rs. 670.00          -do-
                                     Injections
                                     Each vial contains:-
                                     Cefoperazone (as Sodium)..1000mg
                                     Sulbactamf (as Sodium)…1000mg
                                     (Antibiotic)

49.            -do-                  Cefpimed 500mg Dry Powder           Vial   Rs. 224.00          -do-
                                     Injections
                                     Each vial contains:-
                                     Cefpirome……500mg
                                     (Antibiotic)

50.            -do-                  Cefpimed 1g Dry Powder Injections   Vial   Rs. 449.00          -do-
                                     Each vial contains:-
                                     Cefpirome……1g
                                     (Antibiotic)

51.            -do-                  Medizolin 250mg Dry Powder          Vial   Rs. 45.00           -do-
                                     Injections
                                     Each vial contains:-
      bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                               54
                                     Cefazolin (as Sodium)…250mg

52.            -do-                  Medizolin 500mg Dry Powder           Vial    Rs. 66.00          -do-
                                     Injections
                                     Each vial contains:-
                                     Cefazolin (as Sodium)…500mg

53.            -do-                  Medizolin 1g Dry Powder Injections   Vial   Rs. 116.00          -do-
                                     Each vial contains:-
                                     Cefazolin (as Sodium)…1g

54.            -do-                  Cefozone 250mg Dry Powder            Vial    Rs. 94.00          -do-
                                     Injections
                                     Each vial contains:-
                                     Cefoperazone (as Sodium)…250mg

55.            -do-                  Cefozone 500mg Dry Powder            Vial   Rs. 187.00          -do-
                                     Injections
                                     Each vial contains:-
                                     Cefoperazone (as Sodium)…500mg

56.            -do-                  Cefozone 1g Dry Powder Injections    Vial   Rs. 270.00          -do-
                                     Each vial contains:-
                                     Cefoperazone (as Sodium)…1g

57.     M/s. Zesion                  Zefexone 250mg IM Injections         1‟s    Rs. 90.00    Approved subject
      Pharmaceutical                 Each vial contains:-                         New name    to confirmation of
        , Islamabad                  Ceftriaxone Sodium eq. to                     Curezef    renewal of licence
           contract                  Ceftriaxone……250mg                                       and        HVAC
       manufacturing                 (3rd Generation Cephalosporin)                           system.
      by M/s. English
      Pharmaceutical                                                                          2. Grant of toll
          , Lahore                                                                            manufacturing
                                                                                              permission may
                                                                                              not be acceded to
                                                                                              such firms if
                                                                                              more than one
                                                                                              sample is failed
                                                                                              and       similarly
                                                                                              contract
                                                                                              manufacturer
                                                                                              may      not     be
                                                                                              allowed if any
                                                                                              sampleis declared
                                                                                              substandard in the
                                                                                              relevant section
                                                                                              dedicated       for
                                                                                              contract
                                                                                              manufacturing.

                                                                                              3. Availability of
      bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                                 55
                                                                                           M/s. English for
                                                                                           manufacturing 50
                                                                                           products, if M/s.
                                                                                           English      have
                                                                                           crossed the 50
                                                                                           products limit, the
                                                                                           manufacturer may
                                                                                           be changed to the
                                                                                           GMP complaint
                                                                                           firm          after
                                                                                           fulfillment      of
                                                                                           requirements of
                                                                                           contract    policy
                                                                                           and Chairperson
                                                                                           Registration
                                                                                             Rs.101.00/vial

                                                                                                1st…..42
58.            -do-                  Zefexone 500mg IM Injections             Rs. 170.00           -do-
                                                                        1‟s    New name
                                     Each vial contains:-
                                                                                Curezef      Rs.170.00/Vial
                                     Ceftriaxone Sodium eq. to
                                     Ceftriaxone……500mg                                          st
                                                                                                1 ….43
                                     (3rd Generation Cephalosporin)


59.            -do-                  Zefexone 500mg IV Injections       1‟s   Rs. 170.00          -do-
                                     Each vial contains:-                     New name       Rs.170.00/Vial
                                     Ceftriaxone Sodium eq. to                 Curezef           st
                                                                                                1 ….43
                                     Ceftrieaxone…….500mg
                                     (3rd Generation Cephalosporin)

60.            -do-                  Zefexone 1g IV Injections          1‟s   Rs. 290.00          -do-
                                     Each vial contains:-                     New name       Rs. 321.00/1’s
                                     Ceftriaxone Sodium eq. to                 Curezef           st
                                                                                                1 …..41
                                     Ceftrieaxone…….1g
                                     (3rd Generation Cephalosporin)

61.            -do-                  Zefotax 250mg IM/IV Injections     1‟s   Rs. 60.00           -do-
                                     Each vial contains:-                     New name        Rs.60.00/vial
                                     Cefotaxime Sodium eq. to                 Guardzef
                                     Cefotaxime…….250mg                                         5th….59
                                     (3rd Generation Cephalosporin)

62.            -do-                  Zefotax 500mg IM/IV Injections     1‟s   Rs. 110.00         -do-
                                     Each vial contains:-                     New name       Rs.110.00/vial
                                     Cefotaxime Sodium eq. to                 Guardzef         5th….61
                                     Cefotaxime…….500mg
                                     (3rd Generation Cephalosporin)

63.            -do-                  Zefotax 1g IM/IV Injections        1‟s   Rs. 180.00          -do-
      bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                                   56
                                     Each vial contains:-                   New name      Rs.160.00/vial
                                     Cefotaxime Sodium eq. to               Guardzef
                                     Cefotaxime…….1g                                           5th….60
                                     (3rd Generation Cephalosporin)



64.            -do-                  Ceftam 1gm IM/IV Injections            Rs. 380.00          -do-
                                                                      1‟s
                                     Each vial contains:-                   New name
                                     Cefoperazone Sodium eq. to               Ceone      Rs.250.00/Vial
                                     Cefoperazone……...500mg
                                     Sulbactam…………500mg                                    14th…PRC
                                     (3rd Generation Cephalosporin)



65.            -do-                  Ceftam 2gm IM/IV Injections      1‟s   Rs. 600.00       -do-
                                     Each vial contains:-                   New name     Rs.350.00/1‟S
                                     Cefoperazone Sodium eq. to               Ceone
                                     Cefoperazone……...1000mg                                    14TH
                                     Sulbactam…………1000mg
                                     (3rd Generation Cephalosporin)


66.            -do-                  Zetum 250mg IM/IV Injections     1‟s   Rs. 120.00       -do-
                                     Each vial contains:-                   New name     Rs.100.00/1‟s
                                     Ceftazidime Sodium eq. to               Zidizef
                                     Ceftazidime……...250mg                                     6th….56
                                     (3rd Generation Cephalosporin)

67.            -do-                  Zetum 500mg IM/IV Infusion       1‟s   Rs. 180.00        -do-
                                     Each vial contains:-                   New name       Rs.144.00
                                     Ceftazidime Sodium eq. to               Zidizef
                                     Ceftazidime…….500mg                                       6th….57
                                     (3rd Generation Cephalosporin)

68.            -do-                  Zetum 1g IM/IV Infusion          1‟s   Rs. 350.00       -do-
                                     Each vial contains:-                   New name     Rs.275.00/1‟s
                                     Ceftazidime Sodium eq. to               Zidizef
                                     Ceftazidime…….1g                                          6th…58
                                     (3rd Generation Cephalosporin)


            Following Products Applications did not fall under the ambit of contract policy.

69.      M/s Ipram                   Ipradin 2mg Tablets                     As per      Rejected on the
       International,                Each Tablet contains:                   Policy      grounds did not
         Islamabd                    Tizandidine Hcl eq. To                               fall under the
       Manufactured                  Tizanidine..2mg                                          contact
       by M/s. M/s.                                                                      manufacturing
          Navegal                                                                        policy because
      bf984aa7-74e2-4a46-bf8b-1103b1c7cc26.doc
                                                                 57
       Laboratories,                                                                  only dedicated
        41/1-A-2,                                                                   facilities could be
          Phase-I,                                                                   out sourced for
         Industrial                                                                       contract
       Estate Hattar.                                                                 manufacturing

70.            -d0-                  Elozar 20mg Capsule                   As per          -d0-
                                     Each Capsule Contains:                Policy
                                     Omeprazole Pellets eq to
                                      Omeprazole……………….20mg
                                     (Proton Pump Inhibiter)



71.            -do-                  Elozar 40mg Capsule                   As per          -do-
                                     Each Capsule Contains:                Policy
                                     Omeprazole Pellets eq to
                                      Omeprazole……………….40mg
                                     (Proton Pump Inhibiter)

72.            -do-                  Socap 40mg Capsule                    As per          -do-
                                     Each Capsule Contains:                Policy
                                     Esomep;razole Magnesium Pellets
                                     eq. To Esomeprazole……40mg
                                     (Proton Pump Inhibiter)

73.            -do-                  Zonep 15mg Tablet                     As per          -do-
                                     Each Tablet Contains:                 Policy
                                     Pioglitazone Hel eq. To
                                     Pioglitazone…..15mg
                                     (Oral antidiabetic Agent)

74.            -do-                  Zonep 30mg Tablet                     As per          -do-
                                     Each Tablet Contains:                 Policy
                                     Pioglitazone Hel eq. To
                                     Pioglitazone………….30mg
                                     (Oral antidiabetic Agent)
75.            -do-                  Levopram 250mg Tablet                 As per          -do-
                                     Each Tablet Contains:                 Policy
                                     Levofloxacin (Hemihydrate), eq. Tto
                                     Levofloxacin…………250mg
                                     (fluorinated carboxyquinolone)
76.            -do-                  Cip-ram 250mg Tablet                  As per          -do-
                                     Each Tablet Contains:                 Policy
                                     Ciprofloxacin
                                     Hcl(monohydrochloride) eq. To
                                     Ciprofloxacin………250mg
                                     (fluorinated carboxyquinolone)
77.            -do-                  Oflo 200mg Tablet                     As per          -do-
                                     Each Tablet Contains:                 Policy
                                     Ofloxacin……………200mg
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                                                                 58
                                     (fluorinated carboxyquinolone)

78.   M/s. Ambrosia                  Levopram 500mg Tablet                 As per   -do-
      Pharmaceutical                 Each Tablet Contains:                 Policy
         s, Rawat,                   Levofloxacin (Hemihydrate), eq. Tto
        Islamabad.                   Levofloxacin…………500mg
       manufactured                  (fluorinated carboxyquinolone)
       by M/s Ipram
       International,
         Islamabd
79.         -do-                     Ambibalamin Injection                          -do-
                                     Each Ampule contains:
                                     Mecobalamin……………….500mg
                                     (Co-enzyme type vitamin B 12 )




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                                                                 59
         ITEM NO. 5

                      Cases Of Expert Opinion For Registration Of New Molecule Recommended Or Not
                      Recommended By The Experts

1 M/s Genix Pharma                                                             Dr. Nisar ur Rehman
  (Pvt.) LTD., Karachi Dr. Rafeeq Alam Khan
                                                                               The expert have pointed out following SEVERE
   Desgen Oral Liquid                                                          DEFICIENCIES:-
                 Syrup                 Following                               1.    The scientific literature provided by the firm seems to
   Each 5ml contains:                  SHORTING                                be down loaded from Schering/ Plough Ltd/ EMEA & does
                                       COMINGS have been                       not contain any scientific references for efficacy & safety of
   Desloratadine                       pointed out:-                           Desloratidine.
   ........0. 5mg                      1. Though safety profile has been       2.    In the provided literature (7/59 EMEA 2004)
                                       established earlier Post marketing
                                       surveillance studies should be          desloratidine is stable at pH 5 to 6. But the stability data
                                       conducted in local population to        provided by the firm showed stable results at pH 3.1.
   Pack Size :                         eradicate probable chance of
                                       genetic variation.                      Moreover, the manufacturing formula of syrup does not
   Price:                                                                      contain any ingredient, which provides this pH, nor contain
                                       2. Composition is not inline with
                                       European Pharmacopoeia & the            any buffer system, which indicates that the data is fake.
                                       non-compendial excipients are
                                       Color E 110 & Bubble Gum                3.    In the two trial batches for the stability study, “pH of the
                                       Flavour No. 15864.                      suspension” is mentioned instead of syrup.
                                       1. The data sheet provided by the       4.    No detail for method of manufacturing, instead it is
                                       firm showing stability test of
                                       product which does not indicate         mentioned “Collect the powder in polythine lined drums &
                                       temperature & relative humidity         weigh” which should be for the tablets after completion of
                                       which is required to be mentioned.
                                       Further the packaging requirement       granulation process & not for syrup.
                                       should also be mentioned since it       5.    Incomplete information regarding manufacturing,
                                       greatly influences the quality
                                       /stability    of      the    product.   packaging & in process controls/ Q.C tests.
                                       Appropriate packaging seems to be
                                       Amber glass bottle (Ph. Eur. Type
                                       III) with a child resistant poly
                                       propylene cap & label should
                                       indicate “ not to store above 30 C.
                                       2. The demand price of the
                                       product has also not been
                                       mentioned in the dossier.


                                       The firm has been informed
                                       accordingly & its reply is awaited.



   Decision: Rejected on the grounds that the information submitted by the firm was incomplete to justify the
   grant of registration.

2 M/s M/s HILTON                                                                                    Dr. Sattar Baksh
  PHARMA (Pvt.)                        Prof. Dr. Javaid Iqbal                  Associate Prof. Of Pharmaceutics
  LTD., Karachi                  Chairman Deptt. of                            Gomal University
                                 Pharmacy,                                     D.I. Khan
   MODACT 100 MG University of                                                 1. The drug is safe & effective.
                          Tablet Baluchistan                                   2. The final print labeling must be identical to enclosed
   Each Tablet                   Quetta.                                       labeling.
   contains:                                                                   3. Validations of the regulatory methods are complete.
   Modafinil                     The      product   is                         4. The firm may be asked to submit introductory promotional
   .....................100mg RECOMMENDED                                      materials.
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                                                                                  60
                           with the condition that 5. The firm should also send one market package of the drug
   MODACT 200MG            following instructions when it is available.
                    Tablet must be placed on
   Each Tablet             label.
   contains:               1. It should be used one
   Modafinil ......200mg hour after meal.
                           2. The drug is not
                           recommended            in
   Pack size:
                           pregnancy.
   Price:                  3. Not to be used in
                           case of left ventricular
                           hypertrophy.
                           4. Not to be used in
                           case of mitral valve
                           prolapse syndrome
                           5. In case of psychosis.
                           6. In case of severe
                           hepatic      impairment,
                           reduced doses should
                           be administered.
                           7. Avoid alcohol with
                           the use of modafinil.
                           8. Not recommended in
                           ages below 16 & above
                           65.

   Decision:        The request of the firm was acceded on the recommendations of experts.

3 M/s Searle (Pvt.)                    Dr. Nazar M. Ranjha        Colonel Akbar Waheed
   LTD., Karachi.                      Faculty of Pharmacy        Assoc. Prof. Of Pharmacology
   GLIMP-1 Tablet                      Bahauddin Zakariya         Rawalpindi.
   Each Tablet contains:               University, Multan.
   Pioglitazone .......15mg                                    1. Pioglitone A thiazolidinedione der which reduce both fasting &
   Glimperide………1mg                                            post prandial hyperglycaemia by increasing target tissues sensitivity
   Pack size: 10‟s          1. The therapeutic                 to insulin. It is used as mono therapy or in combination with insulin
   Price: Rs. 180           effectiveness of product           or other Antidiabetic drugs. It can induce cyto-P450 enzyme.
                                                                                    nd
                                       is further enhanced 2. Glimperide A 2 generation sulphonylurea which is more potent
   GLIMP-2 Tablet                      when both the drugs are than older drugs. Promotes insulin release Hypoglycaemia in over
   Each Tablet contains:               administered         in dosage is the main adverse effect.
   Pioglitazone                        combination.            Both are cost effective & RECOMMENDED for registration
   ........15mg
   Glimperide………2mg 1. The                       cost of the
                                       producthould        be
   Pack size: 10‟s                     reduced top facilitate
   Price: Rs. 250                      the patient.
                                       RECOMMENDED
                                       For Registration.

   Decision:         The request of the firm was acceded on the recommendations of experts



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                                                                      61
4 M/s S. J & G Fazul                   DR. JAMAL ZAFAR           DR. ABDULLAH DAYO
   Ellahi (Pvt), Ltd.                  Assoc. Professor          Faculty of Pharmacy
   Karachi.                            Department       of       Univaersity of Sindh
   Hidrofax Tablets                    General Medicine          JAMSHORO.
   200mg
                                       PIMS
   Each Tablet contains:                                         1. The product is effective as anti-diarrhoeal agent & the
   Rifaximin. …200mg
                                       ISLAMABAD
                                                                 treatment of patients (equal or less than 12 years age children
   Pack size:                                                    patients) with traveler diarrhea caused by non invasive strains
   Price:                              1. The drug is used for   of Escherichia coli.
                                       travellor     diarrhea    2. It is a non-systemic (does not get into blood stream) antibiotic
                                       caused      by     non    used to treat diarrhea caused by eating food or drinking fluids
                                       envarim of E. coli.       that have been contaminated with germs or bacteria. The drug
                                       2. Having no systemic     passes into almost entirely in your gut or the G.I.T & remains in
                                       effective, it has the     the G.I.T. It is not suitable for treating other infections such as
                                       edge over the other       chest, sinus, or lungs infections caused by bacteria.
                                       antibiotics used for      3. Cost comparison is as follows.
                                       treating      travellor
                                       diarrhea.                  Products                  Price              Daily cost
                                       3. RECOMMENDED             Zithromax                 Rs.733/6‟s         2 Tablets
                                       for Registration at a      (Azithromycin)                               Rs.244/-
                                       comparable price to
                                       other antibiotics used     by Pfizer
                                       for          Travellor     Ciproxin                  Rs.504/10‟s        2 Tablets
                                       Diarrhea.
                                                                  (Ciprofloxacin)                              Rs.100/-
                                                                  by Bayer
                                                                  Hydrofax                  Rs.300/10’s        3 tablets
                                                                  (Rifaximin)                                  Rs.90/-
                                                                  By S. J & G Fazul


   Decision: Deferred for verification of proof of its registration in developed countries in the applied / claimed
   indication along with verification of availability of manufacturing technology by the firm and its source of
   transfer.

5 M/s Hilton Pharma,                   Dr. Rafeeq       Alam Dr. Shebaz Ahmed Qureshi
   Pvt, Ltd.                           Khan,                     Consultant Cardiology
   Karachi.                            Chairman,                 Head of the Department of Cardiology
   Co-Telsan Tablets                   Biochemical               Federal Government Services Hospital
   40/12.5                                                       P.O Box 2577
                                       Pharmacology        &
   Each tablet contains:                                         Islamabad.
   Telmisartan………..40
                                       Toxicology
                                                                 1. It has been found that all the three strengths of the said
   mg                                  University of             product have established clinical use in US, EU & other
   Hydrochlorothiazide                 Karachi.                  countries since 2001.
   …..12.5 mg                                                    2. This combination is FDA approved & used for superior
   Pack Size: 14‟s                     1. Safety is well         control of hypertension in patients who showed inappropriate
   Price:Rs.910/-                      established.              control with:
   Pack Size: 28‟s                     2. Category C during            a. Losartan /HCTZ combination
   Price:Rs.1820/-                     first trimester & D             b. Amlodipine/ HCTZ combination
                                       during 3rd trimester            c. Atenolol/ HCTZ combination
   Co-Telsan Tablets                   of pregnancy.                   d. Telmisartan mono-therapy
   80/12.5                                                       Being an ARB plus diuretic, it will have better control over
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                                                                    62
Each tablet contains:              3. Not carcinogenic up systolic hypertension & in patients with diabetes.
Telmisartan………..80                 to 1000mg/kg/day.      3. In large number of patients & in different clinical setting, the
mg                                 2. The price may be reduced             combination of Telmisartan/ HCTZ data showed no interaction
Hydrochlorothiazide                proportional to the International       between both ingredients. This combination has a positive
                                   market.
…..12.5 mg                         3. Twelve months            stability   benefit/ risk balance in patients of hypertension on the basis of
Pack Size: 14‟s                    studies have been provided while        available data.
                                   shelf life of 3 years is given. The
Price:Rs1610/-                     firm has been asked for this            4. This combination is available with following brands:
Pack Size: 28‟s                    query. Its reply is awaited.                  Micardis HCT
Price:Rs.3220/-                                                                  Micardis Pus
                                   4.   RECOMMENDED
                                                                                 Pritor Plus
Co-Telsan Tablets                                                          5. The price may be reduced according to the local conditions
80/25                                                                      though lower than that of International brands.
Each tablet contains:                                                      6. RECOMMENDED for registration.
Telmisartan………..80
mg
Hydrochlorothiazide
…..25 mg
Pack Size:14‟s
Price:Rs.1680/-
Pack Size:28‟s
Price:Rs.3360/-


     Decision:                 The request of the firm was acceded on the recommendations of experts




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                                                                              63
SUPPLEMENTARY AGENDA

Item No. 6 Miscellaneous cases.



Case No. 1:                  BULK IMPORT AND LOCAL CONTRACT MANUFACTURING
                             PERMISSION OF REGISTERED DRUGS.


                          M/S         Werrick   Pharmaceuticals   Islamabad   have     requested   for   contract
manufacturing permission of their following drugs from M/s. Scotmann Pharmaceutical,
Islamabad by way of Bulk Import. The subject products will be imported as concentrate and
local repacking at M/s. Scotmann Pharmaceutical, Islamabad. At this stage the relevant facilities
are being setup at M/s. Werrick Pharmaceuticals. The firm has informed that their sister concern
unit, Scotmann Pharmaceutical, Islamabad have approved Section of Injectable /Sterile
Manufacturing:-
                         S. #              Product Name (Werrick)             Registration No.
                         1.         Cell-Aid Depot Injection 50mcg                036096
                                    (Interferon Alfa 2b)
                          2.        Cell-Aid Depot Injection 80mcg                   036097
                                    (Interferon Alfa 2b)
                          3.        Cell-Aid Depot Injection 100mcg                  036098
                                    (Interferon Alfa 2b)
                          4.        Cell-Aid Depot Injection 120mcg                  036099
                                    (Interferon Alfa 2b)
                          5.        Cell-Aid Injection Alfa 2a 3miu                  035798
                                    (Interferon Alfa 2a)
                          6.        Cell-Aid Injection Alfa 2b 3miu                  035799
                                    (Interferon Alfa 2B)



2.                        Moreover the requested actives are registered, manufactured and marketed by
M/s. Scotmann Pharmaceutical at their own. The detail is as under.


Decision:                 The request of the firm was acceded to for a period of two years subject to
fulfillment of conditions of the contract manufacturing policy.




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