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					      MINUTES OF 197 TH MEETING OF DRUG REGISTRATION BOARD
                       HELD ON 3 RD –4TH MAY, 2006 (REG-II-SOUTH).


                     The 197th meeting of the Drug Registration Board was held on 3 rd – 4th May,
2006 in the Committee Room of Ministry of Health, Islamabad under the Chairmanship of Dr.
Abdul Majid Rajput, Director General Health. It commenced with the recitation of verses from
the Holy Quran and was attended by the following members:-

1.                   Maj. Gen. ® MI Burney HI (M), SI
                     National Institute of Health, Islamabad
2.                   Maj. Gen ® Nasir- ul-Islam Rawalpindi.

3.                   Brig. Muzammil Hassan Najmi,
                     Professor of Pharmacology and Head of Department,
                     Army Medical College, Rawalpindi.

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

5.                   Dr. I.U Beg, Surgeon,
                     Federal Government Services Hospital,
                     Islamabad

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

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

8.                   Representative
                     M/o. Industries & Production, Islamabad

9.                   Animal Husbandry Commissioner,
                     M/o. Food, Agriculture & Livestock,
                     Islamabad

10                   . Cost Accountant,
                     M/o. Health, Islamabad.

11.                  Dr. Farnaz Malik,                               (Also Secretary of the Board)
                     Drugs Controller, Ministry of Health,
                     Islamabad.
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          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. Baber Mahmood representative of Pakistan Pharmaceutical Manufacturers
Association, Mr. M.Zafar Mooraj, representative of Pharma Bureau, Karachi, Dr. Soo mro,
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
                     Confirmation of the minutes of 196th of Registration Board held on 22nd – 23rd
          February, 2006.


Decision:            Draft Minutes of the 196th meeting were circulated to all the members of CL & RB and
no observation was received from any member. The members unanimously confirmed / approved all
the decisions conveyed through the draft minutes of 196th meeting.

Item No. II

                     PERSONAL HEARING IN CASE OF MANUFACTURE & SALE OF
                     “SPURIOUS / UNREGISTERED ” LOZONE INJECTION 1GM I.V,
                     (BATCH NO.130), AND UNREGISTERED “ZEZON 1GM & 25OMG
                     INJECTIONS (BATCH NO. 255 & 256) MANUFACTURED BY M/S
                     ROBINS PHARMACEUTICALS INDUSTRIES, ISLAMABAD FOR TOLL
                     MANUFACTURING OF M/S LLOYD’S         PHARMACEUTICALS,
                     ISLAMABAD.


                     Federal Inspector of Drugs have reported that M/s. Robins Pharmacetical,
Islamabad and M/s. Lloyd’s Pharma, Islamabad are involved in manufacturing and sale of
spurious / unregistered “Lozone 1gm Injection” (Batch No. 130) manufactured by M/s. Robins
Pharmaceutical, Islamabad for M/s. Lloyd’s Pharma, Islamabad He has relied on the various
evidences in addition to following:-

                     1).      Ashiq Saleem of M/s. Lloyds Pharmaceuticals, Islamabad issued an
                              authority letter for the production of 1 lac “Lozone 1gm Injections”
                              vide his letter no. Zesion / 0429.05/05 nominating Nazar Hussain
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                              and Ashiq Mirza as coordinators for production, addressing Tariq
                              Mahmood of M/s. Robins pharma, Islamabad. He duly received 7
                              lacs rupees, 6 lacs (in cash) and one lacs open check No. 1005143
                              dated 06--5-2005 of    PICIC Bank and duly issued receipt no. 531
                              and 533 dated 05-05-2005 signed by accountant of Zesion
                              Pharmaceutical, Islamabad.


                     2).      Tariq Mehmood of M/s. Robins Pharmaceuticals, Islamabad issued
                              printing order for the printing of unit cartons and labels of “Lozone
                              1gm Injections” on 23-06-2005 to M/s. Masson Printers, Lahore. A
                              specimen of label duly initialed by Tariq was also sent with the
                              printing order.


                     3).      M/s. Robins Pharmaceuticals, Islamabad manufactured 1 lac vials
                              of said injections and these injections were distributed by Nazar
                              Hussain & Ashiq Mirza as below:-
                              i) A quantity of 40131 & 9869 of Lozone 1gm Injection
                                 Batch No. 130 were sent to Nazar Hussain & Ashiq
                                 Mirza who delivered these injections to M/s. Amjad
                                 Medicine Company, Lahore and received payment and
                                 sent to the M/s. Robins Pharmaceuticals, Islamabad in
                                 various timings.

                              ii) Nazar Hussain also stated that 10,000 Injections were
                                  sold to M/s. Zain Medicine Company, Lahore.

                              iii) A quantity of 35,000 Injections were sold to M/s. Shaukat
                                   Medicos, Hafizabad Road, Gujranwala.

                              iv) A quantity of 5,000 Injection were sold to M/s. Iqbal
                                  Medicine Company, Lahore.

                     4).      It is also proved through record as well as statement of. Nazar
                              Hussain Shahzad and Amjad Mehmood of M/s. Amjad Medicine
                              Company, Lahore that these Injections were manufactured after
                              June, 2005 (the name was changed to Zezon Igm Injection since 02-
                              10-2004). Even after the expiry of validity permission for
                              manufacturing of “Zezon 1gm Injections”..


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                     5).      The record of the firm also is evident that the manufacturing of
                              “Lozone 1gm Injections (Batch No. 130) was repeatedly conducted
                              by M/s. Robins Pharmaceutical, Islamabad even after the date of
                              change of name of registered drug from Lozone “ to “Zezon”


                     6).      The sample forwarded by the complainant was sent to the Central
                              Drugs Testing Laboratory, Karachi under the kind direction of
                              Honourable Court which was declared spurious vide test report No.
                              276/2006 dated 29-3-2006.


                     7).      A raid was conducted by Federal Inspector of Drugs on 1-4-23006
                              on M/s Zam Zam, Traders, Iqbal Road, Rawalpindi and recovered 10
                              vials of Lozone 1gm injection, Batch No. 130 manufactured by M/s
                              Robins       Pharmaceuticals,   Islamabad      for    M/s     Lloyd’s
                              Pharmaceuticals, Islamabad. The sample was sent to the Central
                              Drugs Testing Laboratory on the same day. M/s Zam Zam Traders,
                              Rawalpindi provided invoice No. 00955 dated 17-5-2005 showing
                              his source of purchase from M/s Werth Pharmaceutical, Rawalpindi
                              who purchased 4600 vials of same injection from M/s Amjad
                              Medicine Company, Lohari Gate, Lahore on 1-11-2004 and 2-4-
                              2005. M/s Amjad Medicine Company confirmed warranty &
                              purchased said injection from M/s Robins Pharmaceuticals, through
                              invoice No. 114 dated 6-10-2004 and invoice No. 119 dated 11-10-
                              2004 Robins Pharmaceutical, Islamabad have recalled the said drug
                              from M/s Amjad Medicine Company, Lahore on technical ground
                              which proves that said drug is manufactured by                 Robins
                              Pharmaceutical,    Islamabad.   Director,   Central Drugs     Testing
                              Laboratory, Karachi has declared said injection spurious vide his test
                              report No. 381 A&B/2006 dated4-4-2006.


                     8).      Federal Inspector of Drugs Lahore seized “Zezon 1gm & 25mg
                              Injections” of manufactured in December, 2005. Similarly Federal
                              Inspector of Drugs, Islamabad also recovered the labeling material of
                              said “Zezon Injections” during his inspection on 6 th February, 2006,

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                              which were burnt to ashes and sample was seized. These labels were
                              also having manufacturing date of December, 2005.


                     9).      All the warranties of “Lozone 1gm Injections” were issued in back
                              date which injections were supplied after duly, 2005. This was
                              confirmed through the statements of purchasers who received
                              warranties.
Contraventions :


          According to the evidences collected by the Federal Inspector of Drugs and various
panels of Ministry of Health, both firms have committed following contraventions of Drugs Act,
1976 and rules framed there under.

                     i.       Manufacturing / sale of spurious injection Lozone which is
                              contravention of section of 23 (1) (a)(i) of Drugs Act, 1976 which is
                              cognizable offence under section 27(1)(a) read with section 30(2)(a)
                              of Drugs Act, 1976.


                     ii.      Manufacturing / sale of unregistered Lozone and Zezone injections
                              after the validity periods is in gross contravention of section
                              23(I)(a)(vii) of Drugs Act, 1976 which is cognizable offence under
                              Section 27(1)(a) read with 30(2)(a) of Drugs Act, 1976.


                     iii.     Manufacturing of misbranded drugs, which is in contravention of
                              section 23(I) (a) (iii) of Drugs Act, 1976.


                     iv.      Increase in shelf life i.e. expiry from 3 to 4 years for Lozone 1gm
                              injection Batch No. 130, which is also in contravention of section
                              23(I)(a)(ix) of Drugs Act, 1976.


                     v.       Submission of misleading information on dated 31-12-2005 to the
                              first team of Ministry of health which visited M/s Robins
                              Pharmaceuticals, Islamabad that reference drug is not manufactured
                              by them which is also in contravention of section 23(I)(f) of Drugs
                              Act, 1976.
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                     vi.      Application   of   incorrect   batch   numbers    by     M/s   Robins
                              Pharmaceuticals Ltd, Islamabad which is in contravention of section
                              23(I)(j) of Drugs Act, 1976. Subsequently following contraventions
                              have also been committed by M/s Robins Pharmaceuticals,
                              Islamabad and M/s Lloyd’s Pharmaceuticals, Islamabad.


                     vii.     Both of them have also issued false warrantees in respect of injection
                              Lozone 1gm, Batch No. 130 which is in contravention of section
                              27(2)(b) of Drugs Act, 1976.


                     viii. Ashiq Saleem Proprietor / MS of M/s Lloyd’s Pharmaceuticals and
                              Chief Executive of M/s Zesion Pharmaceuticals, Islamabad also
                              violated section 27(3) of Drugs Act, 1976 by disobeying lawful
                              authority / obstructing the inspectors during the course of
                              investigations on 22-3-2006, for which he liable also to be
                              prosecuted under sections 186/353 of the P.P.C and ancillary
                              sections.


                     ix.      Both firms have violated the condition of license under section 23
                              (1) b of Drugs Act, 1976 and rules framed there under.


                     Both firms were show caused under Section 41 & 42 of Drugs Act, 1976 and rules
framed there under that why the following actions shall not be initiated against the both firms
because both have knowingly and willingly committed above mentioned violations:-


                     i.         Cancellation / withdrawal of all the permissions for toll
                                manufacturing to both firms in either way through contract
                                manufacturing.

                     ii.        Cancellation / withdrawal of all the drugs registrations granted to
                                both firms under Section 7 of Drugs Act, 1976.

                     iii.       Cancellation of Drugs Manufacturing Licenses o f both firms.

                     iv.        Suspension of Drugs Manufacturing Licenses or extension in
                                sealing for three (3) months as requested by the FID, Islamabad.

                     v.         Permission for prosecution in the Drug Court.

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                     vi.        Any other action, which the Central Licensing & Registration
                                Board deems, fit in accordance with law.


                     Chief Executives / Directors / Partners of both firms are called upon for personal
hearing.


Personal Hearing Of M/s. Lloyd’s (Ashiq Saleem)

                     Mr. Ashiq Saleem appeared along with Syed Zulfiqar Abbas Naqvi Counsel and
Mr. Shamas production incharge of M/s. Lloyd’s. He submitted copies of his written statement
on the stamp paper signed by him along with two witnesses. Wherein it was stated that I Ashiq
Saleem son of Allah Bukhsh ID # 149-89002924 resident of I-8/2, Islamabad do hereby
solemnly affirm and declare that:-

                     i.       I am looking after the matters relating to M/s.                Lloyd’s
                              Pharmaceutical, purchase production, distribution recovery recalls
                              and matters relating to toll manufacturing since 1999 up till today.


                     ii.      A dispute is already underway between the M/s. Robins Pharma and
                              me relating to Lozone / Zezone injection.
                     iii.     M/s. Lloyd’s Pharmaceuticals has no facility to produce the said
                              injection since very first day of license and M.O.H. through letter
                              and authorized M/s. Robins Pharmaceuticals to produce the said
                              injection for M/s. Lloyd’s Pharmaceuticals.
                     iv.      I have an agreement with M/s. Robins Pharmaceuticals for toll
                              manufacturing of said injection and all type of responsibility
                              regarding Q. C of the product is on the shoulder of Tariq (Robins
                              Pharma, Islamabad) copy attached.
                     v.       M/s. Robins Pharma provides finish goods with warranty to me on
                              decided rates. Arrangement of raw materials, packing materials and
                              printing materials etec is the solely responsibility of Tariq (Robins
                              Pharma).
                     vi.      That the injections in question was never produced, nor packed or
                              QC checked by M/s. Lloyd’s Pharmacists, or in Lloyd’s premises.



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                     vii.     It is therefore clear that responsibility for substandard drugs
                              injections Lozone (Batch No. 130.) falls on the shoulders of M/s.
                              Robins Pharma.

                     His counsel stated that the allegations are false and frivolous. He said the order of
one lac “Lozone 1gm Injections” was not served by M/s. Robins because it was inadvently
mentioned instead of “Zezon Injections” and it was cancelled. He submitted a copy of letter
purported to be issued by M/s. Robins stating that due to technical reasons we are unable to
produce the same. It was also stated in letter that Mr. Nazar Hussain and Ashiq Mirza should be
informed accordingly. When Mr. Ashiq Saleem was asked that whether he requested for the
manufacture of “Lozone 1gm Injections” (Batch No. 130) and received the same from M/s.
Robins or not. He replied that he did not receive the said batch from M/s. Robins. While when he
was recalled for his written statement dated 16 th January, 2006 wherein he submitted to the F.I.D.
that the under complain batch No. 130 of the said drug was manufactured by M/s. Robins
according to our supply order dated 16 th August, 2004 and also issued recall notices to the
distributors as well as in the newspaper. He could not reply. However, he said that recall notices
were issued under the direction of M/s. Robins. He was also asked about the production of
“Zezon Injections” and issuance of fake warranties. He said as the drug was registered for five
years due to change of name he was eligible for the manufacturing. However, when he was
realized that permission for toll manufacturing was valid up to 7 th June, 2005 and on the same
terms and conditions registration was valid up to 7th June 2005 and as no extension was granted
by the Registration Board and it cannot be manufactured and stands unregistered.



Personal Hearing of M/s. Lloyd’s (Dr. Khalid Mahmood)


                     Mr. Khalid Mahmood also submitted a written statement wherein he stated that:-


                     a.       I got M/s. Lloyd’s Pharma license in 1998.
                     b.       I have given it on lease in 1999 to Ashiq Saleem of M/s. Zeesion
                              Pharma with the condition that he will run it according to Drug Act,
                              1976 and rules framed there under.
                     c.       Ashiq Saleem of M/s. Zeesion Pharma got all the registrations and
                              involved in all sorts of business activities of M/s. Lloyd’s Pharma
                              till today.

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                     d.       On 8th August, 2005, I requested to D.G. (Health) and all
                              departments of drug registrations through letter # Llo yd’s/08/05 that
                              in future only CEOs signatures should be considered authentic in all
                              respects.
                     e.       Regarding above mentioned subject, I come to know when
                              honorable Supreme Court took suiomote          action, against above-
                              mentioned parties.
                     f.       A case for vacation of M/s. Lloyd’s Pharmaceuticals is in the court of Civil
                              Judge Mr. Zafer Tarar, Islamabad against Ashiq Saleem of M/s. Zeesion
                              Pharmaceuticals filed by me.
                     Respected Sir,
                          I am a law abiding person and never involved in any act against the
                           society / state.
                          I am professional, having vast experience involved in Vet. Pharma
                           business since 20 years. Also holding an other license # 000298 for
                           Vet. Pharmaceuticals since 1990 and never ever involved in any
                           contravention of drug act 1976, till today.


                     This incidence occurred recently is not on my part, I can assure your honor, that
after taking it over I will maintain the cGMP requirement and high standard of ethical criteria.

                     He was asked about the status of M/s. Lloyd’s Pharma. He stated that he is the
chief executive. However he leased the factory to Mr. Ashiq Saleem sine 1999 and uptil now the
premises is under his possession / control. I have filed a case in the court for ejectment which is
sub judicious. I am not involved in any act of illegal activity and what happened with “Lozone”
Mr. Ashiq is responsible. He also added all the registration and change name were granted on the
application of Mr. Ashiq Saleem. When he was asked that if all the registrations issued to M/s.
Lloyd’s are cancelled what will be his reaction. He replied I am only concerned with the
manufacturing license.



Personal hearing of M/s. Robins, Islamabad (Tariq Mahmood & Rajab Sultan)

                     The chief executive and other directors and partners were called on for personal
hearing on 3rd May, 2005 at 11:00 A.M. One Mr. Haseeb appeared on behalf of M/s. Robins
Pharmaceuticals, Islamabad and submitted a letter signed by Tariq Mehmood wherein it was
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stated that the letter for personal hearing was received on 2 nd May, 2006 at 04:00 P.M. and due to
short time it is not possible for them to arrange our counsel at a notice of few hours because he
has to come from Lahore. You are requested to please adjourned for next meeting.

                     The representative was realized that the matter was taken up by the M/s. Robins,
Islamabad in the honourable Drugs Court, Rawalpindi and it was the direction of Drugs Court to
discuss the issue of de-sealing in the meeting of Central Licensing & Registration Board
scheduled to be held on 3rd – 4th May, 2006. It was also directed that M/s. Robins should be
accorded an opportunity of personal hearing in this context. Accordingly personal hearing was
given along with the charge sheet             of offences committed and possible actions to be initiated
against the firm. He was also asked to inform the directors / partners to come for personal
hearing on 4th May, 2006.

                     On 4th May, 2006 Tariq Mehmood and Rajab Sultan of M/s. Robins
Pharmaceuticals, Islamabad appeared for personal hearing. They submitted their written reply
which was signed by Tariq Mehmood chief executive of the firm as under:-

                     a.         It is submitted with great respect and regards that the notice under reply
                     was received on 2-5-2006 at about 04:00 Pm. The matter is so lengthy based upon
                     a chain of allegations requiring a detailed reply and at least 15 days time in the
                     light of a very harsh decision taken by the respected Board, for sealing of factory
                     and lodging of F.I.R. However, we are grateful to the Board, that one days time
                     has been granted under heavy pressure, Robins Pharmaceutcial Industries
                     knocked the door of honourable High Court through W.P. No. 1119 / 2006 fixed
                     on 3-5-2006 and 15 days time granted for submission of parawise comments and
                     report by the CL & RB . As such matter is subjudiced before the honorable High
                     Court. Although it is not possible to submit complete and proper reply in
                     accordance with law specially the respected Board is highly prejudice on the basis
                     of illegal information however, keeping in view the respect & honor of the Board,
                     the reply of the allegations are submitted as under:-

                     1. Allegation No. I :
                           Manufacturing / sale of spurious injection Lozone which is
                           contravention of Section of 23 (a) (i) of Drugs Act, 1976 which is
                           cognizable offence under Section 27 (I) (a) read with Section 30 (2) (a)
                           of Drugs Act, 1976.
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                           Reply:
                           M/s. Robins Pharmaceutical Industries neither manufacture nor sell
                           any spurious injection Lozone. There is no lawful evidence against
                           M/s. Robins Pharmaceutical Industries. The samples declared
                           spurious, were not taken for M/s. Robins Pharmaceutical Industries
                           and the possession, from whom the sample was taken, was illegal
                           without lawful warranty as such doubtful. First sample was declared
                           supurious which was presented by Dr. Shams-Uz-Zaman Soomro with
                           the complaint that the injection is spurious, it is stange, how Dr.
                           Shams-Uz-Zaman Soomro came to know without test that the sample
                           is spurious, which is indicating some consipiracy and ignored by the
                           respected Ministry of Health, it is worth mentioning that sample was
                           without lawful warranty under Section 32 (3) of Drugs Act, 1976.
                           Therefore the sample given by Dr. Shams-Uz-Zaman Soomro having
                           no legal value. Similarly the test report Nos. 381-B/2006 both dated 4-
                           4-2006 are value less, clearly indicating the doubts from the papers /
                           documents presented before the August Supreme Court of Pakistan as
                           indicating at pages 35 to 38 clear proof that M/s. Robins
                           Pharmaceutical Industries is innocent. i.e.
                           Page 35 sampling from M/s. Zam Zam Trader Rawalpindi on Form 3
                           dated 1-4-2006 and M/s. Zam Zam Trader submitted the warranty ro a
                           warranty was arranged for Zam Zam Trader for M/s. Werth Pharma,
                           Rawalpindi dated 17-5-2005 & which was produced on 3-4-2006 (at
                           page 36) who purchased from M/s. Amjad Medicine Co. Lahore dated
                           2-4-2005. Page 38 disclosing a conspiracy and pressure and collection
                           of evidence in hurry. That is an affidavit obtained on behalf of M/s.
                           Zam Zam Trader, Rawalpindi with a new story on 3-4-2006 with the
                           words that:-

                     Clearly disclosing the illegalities and violation of mandatory requirements of the
Drugs Act, 1976, under the supervision of the Federal Drug Inspector. The above facts also
disclosing that,



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                            The samples taken from M/s. Zam Zam Trader Rawalpindi in fact
                                were in possession of M/s. United Traders without any warranty as
                                required by law.


                            The samples were taken from United Traders in order to connect the
                                chain of warranties the name of M/s. Zam Zam Trader is used.


                            No sale purchase record taken into possession by the Drug Inspector
                                from M/s.     Zam     Zam       Trader,   United     Traders     &   Werth
                                Pharmaceuticals.


                            The sampling on Form 3 from M/s. Zam Zam Trader who was in
                                possession of Drug in violation / Section 32 (3) of the Drugs Act,
                                1976.
                            As the Punjab Govt. failed to control the manufacturing and sale of
                                spurious Drugs, as indicated in the press (copies enclosed). It cannot
                                be said, however, where the spurious drug was manufactured. But,
                                we can sworn on Holy Quran that we cannot imagine for the
                                manufacturing of spurious drugs nor that drug was manufactured by
                                us. SPECIALLY IN THE FACTS that, the samples taken from
                                Peshawar and from the factory, found up to the standard quality. As
                                is clear from pages 41 & 43 of the parawaise comments submitted by
                                the Drugs Controller (QA) OF ministry of Health.


                     2. Allegation No. II:
                        Manufacturing / sale of unregistered Lozone and Zezone Injections
                           after the validity periods is in gross contravention of Section 23 (I) (a)
                           (vii) of Drugs Act, 1976 which is cognized offence under Section 27
                           (I) (a) read with 30 (2) (a) of Drugs Act, 1976.

                           Reply:
                           We were         informed   by    Ashiq     Saleem       that   M/s.   Lloyd’s
                           Pharmaceuticals, Islamabad deposited the required amount of Rs.
                           8000.00 on 29-7-2005 for renewal / extension / period for toll
                           manufacture and the application was received on 30-7-2005 in the

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                                                           12
                           Ministry of Health, Islamabad. As such the permission / registration
                           was still valid under the proviso the Rule 27 of the Drugs (Licensing,
                           Registering & Advertising) Rule, i.e.;
                           “Provided that an application for the renewal of registration shall not
                           be entertained unless it has been made within sixty days after the
                           expiry of the registration and when an application has been made as
                           aforesaid the registration shall subject toe the orders passed on the
                           application for the renewal continue in force for the e xt period of five
                           years”.
                           It is an admitted fact that, the application for renewal was received on
                           30-7-2005 by the Ministry of Health. We cannot think to violate the
                           law for one drug, Lozone & Zezone and face such situation. As such
                           no such violation has been committed. It is most respectfully
                           submitted that, in the light of the above mentioned admitted facts M/s.
                           Robins Pharmaceutical Industries neither manufacture spurious drug
                           nor unregistered drug as such. The show cause notice is liable to be
                           recalled, keeping in view the manufacturing of remaining registered
                           products.

                     3. Allegation No. III To VII:

                           Reply:
                           Allegations based upon certain misunderstanding which can be
                           remedied under the directions of drug inspectors while performing
                           their routine duties.

                     4. Allegation No. VIII:          Not related.

                     b.         It is also respectfully submitted that I Tariq Mahmood as Chief Executive /
                     Production Incharge is responsible for all the manufacturing processes, no one
                     else from directors having any knowledge etc about the manufacturing of drugs.
                     It is therefore, respectfully submitted that the show cause notice under reply may
                     very kindly be withdrawn / recalled and proceeding initiated against us may very
                     graciously be dropped. It is further requested that appropriate order / directions
                     may kindly be issued for the de-sealing of factory premises enabling us to
                     manufacture the remaining registered drugs strictly in accordance with law.

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                                                         13
                     Tariq Mahmood and Rajab Sultan denied the allegations leveled in the charge
sheet except misbranding and increase in               shelf life. They also said that they did not
manufactured the “Lozone Injection” after the name change. When they were asked about the
evidences collected by the F.I.D for the manufacture they could not defend themselves. They
also denied the cancellation order of one lac Injections submitted by Ashiq Saleem.


Decision:                   The Central Licensing & Registration Board after going through the personal
hearing as well as written replies of the firms and scrutiny of record and evidences collected by
the Federal Inspectors of Drugs, Islamabad and Lahore and after perusal of inspection reports of
various panels of CL & RB unanimously concluded that there is sufficient evidence on record
right from the authority letter by Ashiq Saleem for the production of one lac Vials of “Lozone
1gm Injections” on 5th May, 2005 and printing order for the labeling material by Tariq Mahmood
on 23rd June, 2005 to M/s. Masson Printers, Lahore and production of one lac Vials of “Lozone
1gm Injections” in various dates as it is proved from the bin card record duly signed by Tariq
Mahmood of M/s. Robins and delivery of one lac Vials to Nazar Hussain and Ashiq Mirza who
distributed to various parties at Lahore and Gujaranwala. The affidavits s ubmitted by the Nazar
Hussain, Shahzad & Amjad Mahmood of Amjad Medicine Company, Lahore were also not
denied by the accused parties. The analysis reports were also submitted by the FID through
which drug in question was declared spurious. Both the accused parties failed to defend the
allegations on the basis of evidences. Tariq Mahmood Chief Executive as well as Production
Incharge of M/s. Robins and Ashiq Saleem of M/s. Lloyd’s, Islamabad in collaboration with
Nazar Hussain and Ashiq Mirza played active role in the production and sale of spurious /
unregistered / misbranded “Lozone 1gm Injections” (Batch No. 130) and are involved in this
heinous crime against the humanity. It was also identified that in addition to manufacturing of
spurious drugs no other violations listed in the Section 23 / 27 of Drugs Act, 1976 relevant to the
manufacturer have been left untouched. The increase in shelf life to four (4) years is also
dangerous act of the accused persons, which may result fatal to the patients.          This reflects the
attitude of the involved accused persons. Keeping in view the registration of F.I.R. and
investigations by the Police Authorities and irresponsible of both accused persons related to both
firms it was decided it is necessary to stop the continuation of offences the garb of manufacturing
licenses and drugs registration approvals. Both the culprits should be kept away from the noble
business of drugs manufacturing. To save the public interest, CL & RB decided that following
actions shall be immediately proceeded against the both firms as interim decision till finalization
of case by the Drugs Court. The final decision about the fate of manufacturing licenses as well

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                                                       14
as drugs registrations approval issued to both Tariq Mahmood & Ashiq Saleem will be taken in
the light of decision of the Drugs Court. The stance of Khalid Mahmood Chief Executive of M/s.
Lloyd’s was also considered by the Board but keeping in view the possession of the unit by the
Ashiq Saleem a key offender in the case, it was realized that until the possession of unit is not
obtained by the Chief Executive, Dr. Khalid Mahmood, M/s. Lloyd’s also deems similar
treatment as M/s. Robins Pharmaceuticals, Islamabad because the offences were committed
willingly and knowingly by using the names, licenses as well as premises of both firms. Hence
the Central Licensing & Registration Board keeping in view the conduct of the accused parties as
well as the public interest decided as under:-
                            i.      Cancellation of all the permissions for toll
                                    manufacturing to both firms in either way through
                                    contract manufacturing with immediate effect.

                           ii.      Suspension of Drugs Manufacturing Licenses of M/s.
                                    Lloyd’s Pharma, Islamabad            & M/s. Robins
                                    Pharmaceutical, Islamabad for a period of one year. .

                          iii.      Suspension of all the drugs registrations granted under
                                    Section 7 of Drugs Act, 1976 to M/s. Lloyd’s Pharma,
                                    Islamabad & M/s. Robins Pharmaceutical, Islamabad
                                    for a period of one year

                          iv.       The manufacturing premises of both firms will remain
                                    sealed during this period.

                           v.       After the decision of the case by the Drugs Court,
                                    Rawalpindi, Federal Inspector of Drugs, Islamabad shall
                                    immediately submit the same in the meeting of CL & RB
                                    for deciding the fate of manufacturing licenses and drugs
                                    registrations.

                          vi.       It was also decided that the Federal Inspector of Drugs,
                                    Islamabad shall pursue the case during the Police
                                    Investigations and in the relevant courts keeping the
                                    Chairman and Secretary of the Board fully informed
                                    with the status of proceedings. It was further directed
                                    that the F.I.D shall manage all the witnesses who are
                                    evidences on the part of prosecution and these should be
                                    recorded with the investigating Officer of Police in
                                    accordance with legal formalities.

Item No. III
                     OBSERVATIONS OF APEX COURT ABOUT THE FLOW OF SPURIOUS
                     AND SUBSTANDARD DRUGS IN THE COUNTRY AND NATIONAL
                     QUALITY ASSURANCE SYSTEM AND MEASURES TO IMPROVE THE
                     SYSTEM RELATED TO DRUGS REGISTRATION, PRICING,
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                                                          15
                     UNETHICAL      MARKETING       PRACTICES,                                      ILLEGAL
                     ADVERTISEMENT, IRRATIONAL USE OF DRUGS,                                       NATIONAL
                     ESSENTIAL DRUGS LIST AND SHORTAGES OF DRUGS

                     The honourable Supreme Court of Pakistan has directed the Ministry of Health to
adopt a system which shall result to check the flow of spurious / substandard drugs in the market.
Apex court has also shown concern about the fo llowing matters like drugs registration, drug
pricing, unethical marketing practices, irrational use of drugs, national essential drug list and
shortage of drugs which also shall be attended to. The honourabel Court has directed to submit
comprehensive report on 12th May, 2006.


                     Brief proposals are submitted for improvement in the above areas:-
Decision:
1.                   Flow Of Spurious / Sub-standards Drugs:


                     To check control and monitor the flow of spurious / substandard drugs following
recommendations were approved by the CL & RB to curtail the production of and influx                     of
spurious drugs into the medicine markets:-.


                           i.   According to the information collected during various
                                meeting of regulators of Provincial & Federal Health
                                Authorities, it was unanimous and conclusive decision that
                                the major influx of spurious drugs starts from the wholesale
                                markets and peddlers who conduct their business against
                                the spirit of law. Therefore, it was decided that the forms of
                                warranty shall be amended along with amendment in the
                                relevant clause of Rule 7A of Drugs (Licensing,
                                Registering & Advertising ) Rule, 1976. A new Form 2B
                                has been introduced as an authority letters in Form 2-B
                                (approved specimen enclosed). This authority letter will
                                also specify the jurisdiction of a distributor to conduct sale
                                of drugs        and issuance of warranty on behalf of
                                manufacturer or importer / indenter. Rule 7A has been
                                replaced as under:

                                7A“The indenter, importer, manufacturer                 or their
                                authorized agent (s) / authorized distributor (s) duly holding
                                authority letter in Form 2B shall issue warranty in Form
                                2A for any drug indented or sold by him for the purpose of
                                distribution or retail sale and eligibility of authorized
                                distributor(s) for issuing warranty is limited only to his
                                area of jurisdiction specified in the authority letter.

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                                                          16
                     ii         Similarly Rule 7B is being incorporated to regulate the
                                Inter Provincial sale of drugs which is beyond the scope of
                                Provinces. This rule is as under:-

                                7B “Inter Provincial sale of drugs shall be conducted by the
                                manufacturer(s), Importer(s) or indenter(s) only”.

                     iii.       Import of active raw materials / inactive materials shall be
                                restricted only to the manufacturers under license. Sale of
                                raw materials in the open market or manufacturer to
                                manufacturer is completely banned.

                     iv.        The Provincial and Federal Inspector of Drugs shall initiate
                                action against the sale of active pharmaceutical ingredients
                                in the open market.

                     v.         Regulation of printers under special license for printing
                                labeling and packaging material. For this purpose necessary
                                rules shall be formulated giving the procedure for issuance
                                of license and conditions of such licenses.

                     vi.        Sale of pharmaceutical machinery shall be restricted only to
                                the licensed manufacturers or with valid permission to
                                under license manufacturers. For this purpose necessary
                                rules shall be enacted.

                     vii.       Strengthening of Drugs Testing Laboratories through
                                human resources, budgetary allocations and availability of
                                compatible equipment by the Provincial & Federal Health
                                Governments The Federal Government may use CRF for
                                this purpose making the Central Drugs Testing
                                Laboratories competent enough to test / analyze all the
                                registered drugs.

                     viii.      Enhanced and effective collaboration and coordination
                                among the Provincial and Federal Authorities. Specia lly
                                information about the spurious / substandard drugs and
                                exchange of such information to restrict the availability in
                                the market. Similarly information about the drugs of
                                licensed manufacturers declared spurious / substandard /
                                adulterated for punitive action on the part of Federal
                                Government against the firm along with recommendations
                                if any.


                     ix.        Pharmaceutical firms shall develop their own network for
                                tracing the influx of spurious / unregistered drugs in the
                                market and coordinate with the authorities fo r effective
                                monitoring and eradication and follow up leading to the

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                                                         17
                                cancellation of drug sale licenses of Medical Stores from
                                where such drugs are recovered.


                     x.         All the firms shall adopt the specifications mentioned in the
                                official pharmacopoeias for all the formulations except
                                those drugs not included in the official pharmacopoeias.
                                For these drugs manufacturers may adopt their own
                                specifications till the inclusion of that formulation in the
                                official pharmacopoeias. After this decision firms will not
                                be allowed to adopt their own specifications for the drugs,
                                which are included in any of the official pharmacopoeias,
                                listed in the Section 3 of Drugs Act, 1976.

2.                   Punitive Actions
                     To eradicate the menace of spurious / substandard drugs actions shall be taken
against the defaulters as provided in Drugs Act, 1976 giving proper follow up by the Regulatory
Agencies.
                      Suspension of sale licenses / manufacturing licenses of accused
                       persons held responsible for the possession manufacturing and
                       sale of spurious drugs for the trial period and cancellation of
                       licenses on conviction by the trial court.

                      Ban on conducting the business of drugs for the people
                       convicted by the courts on the charges of handling of spurious
                       or unregistered drugs or any other offences which may
                       endanger the public health.

                      Gazette notification by the relevant government agencies of
                       offenders convicted on the charges of spurious drugs.

                      Suspension / cancellation of manufacturing permission of a
                       particular section for a period of one year whose three (3)
                       samples of different batches of drugs have been declared
                       substandard.

                      Deregistration of drug whose samples have been declared
                       substandard by the two laboratories.

                      Stoppage of grant of new registration to the firms whose
                       samples have been declared substandard till the finalization of
                       the case.

3.                   Drugs Registration Approvals.


                     The system for the registration of drugs also needs to be redefined for the
evaluation of the expertise, capacities, facilities and R & D facilities of the manufacturer to

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                                                         18
manufacture a particular drug before the grant of registration. Following decisions have been
approved by the CL & RB to ensure the quality, efficacy and safety of the drugs before the
approval of registration of drugs:-


                             Maximum number of registered drugs for one section will be defined
                              including new units on the basis of capacity, expertise available and
                              number of already registered drugs being manufactured by the
                              manufacturer. For this purpose a Committee consisting of a member
                              from PPMA, Pharma Bureau and Drugs Control Organization will
                              be constituted to define it as an S.O.P both for the Ministry of Health
                              and stakeholders.


                             Evaluation criteria have been upgraded in accordance with the
                              Current Good Manufacturing Practices (cGMP), Total Quality
                              Control Management and practices adopted by other regulatory
                              authorities   of    the   World.    For   this   purpose     following
                              recommendations have been approved:-


                                a. Applications for the registration of new molecules may
                                   be critically evaluated to ensure the quality, safety and
                                   efficacy of drugs. It was also decided that the clinical
                                   data and prescribing information of the developed
                                   countries might be relied upon. However, the applicant
                                   shall submit clinical trials for post marketing
                                   surveillance within one year of the registration to
                                   determine the safety as well as efficacy and quality.

                                b. For the registration of Me-Too drugs, pharmacological
                                   data and prescribing information of the innovator may
                                   be relied upon. However, it shall be mandatory for the
                                   manufacturer to conduct stability studies including in
                                   vitro studies to ascertain the capability of manufacturer
                                   to manufacture the product of established quality and
                                   efficacy as compared to the branded drugs through
                                   dissolution studies for all those drugs to which USP &
                                   BP have recommended dissolution testing. .

                                c. For this purpose the permission for import of raw
                                   materials for experimental purpose shall be utilized by
                                   the manufacturers to conduct the stability studies,
                                   which shall be first indicator to conduct the process of
                                   drugs development.
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                                                         19
                                d. All the procedures adopted for the production and
                                   quality control during the laboratory and pilot scale
                                   manufacturing shall be validated by the applicant.

                                e. The applicant shall use only those prescribing
                                   information, which was approved in the country of
                                   origin. In case of proven violation to this instruction the
                                   registration of drug shall be liable to cancellation.


                                f. Mandatory pre approval inspections shall be conducted
                                   to verify the manufacturing and quality control data
                                   submitted in the registration application. .

                                g. The samples of pilot production of every drug shall be
                                   submitted to area FID for test / analysis by the
                                   government labs and test report shall be enclosed with
                                   the registration application.

                                h. All the allied processes including water purification
                                   system, HVAC system, validation of processes and
                                   systems shall also be verified before the grant of
                                   registration.

                                i.    Before the grant of registration the need of the drug for
                                      the country will be considered.


4.                   Pricing
                     About the prices of drugs in Pakistan, honourable Supreme Court of Pakistan has
also shown concern specially indicating the availability of Indian drugs in the local market on
cheaper raters. The report of Consumer Protection Network also reflected that medicines are
costly in Pakistan. There are some molecules manufactured by multinational pharmaceuticals at
very higher prices. The same molecules are being manufactured by local pharmaceutical firms at
much lower prices. These few molecules have projected bad impression about the prices in
Pakistan. The examples are given below:-


S. No.         Name of               Name of Drug(s)          Pack      MRP of        MRP of Local companies
               Firm(s)                                       Size(s)      MNC
  1.           M/s. Eli              Zyprexa 5mg               7’s     Rs. 1320.00     Rs. 83.00 per 10’s
                Lilly,               (Olanzapine)                                     “Olanzia” (Werrick)
               Karachi
  2.             -do-                Zyprexa 7.5mg              10’s   Rs. 2981.00
                                     (Olanzapine)


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                                                           20
  3.               -do-            Zyprexa 10mg          28’s   Rs. 9922.00         Rs. 156.00 per 10’s
                                   (Olanzapine)                                    “Olanzia” (Werrick)

  4.          M/s. MSD,            Singulair 4mg         14’s   Rs. 1000.00   1. Rs. 190.00 per 14’s
               Karachi             (Montelukast)                                 “Myteka” (Hilton)

                                                                              2. Rs. 168.00 per 14’s
                                                                                 “Montika” (Sami)


  5.               -do-            Singulair 5mg         14’s   Rs. 1205.00   1.    Rs. 120 per 14’s
                                   (Montelukast)                                    “Regulair” (Werrick)

                                                                              2. Rs. 287.00 per 14’s
                                                                                 “Myteka” (Hilton)

                                                                              3. Rs. 182.00 per 14’s
                                                                                 “Montika” (Sami)


  6.               -do-            Singulair 10mg        14’s   Rs. 1301.79   1. Rs. 235 per 14’s
                                   (Montelukast)                                 “Regulair” (Werrick)

                                                                              2. Rs. 313.00 per 14’s
                                                                                 “Myteka” (Hilton)

                                                                              3. Rs. 210.00 per 14’s
                                                                                 “Montika” (Sami)

  7.           M/s. P.D.           Lipitor 10mg          10’s   Rs. 662.81    1. Rs. 100.00 per 10’s
                Pfizer             Atorvastatin                                  “Lipirex (Highnoon)

                                                                              2. Rs. 212.96 per 10’s
                                                                                 “Recol” (Barrett)

                                                                              3. Rs. 95.00 per 10’s
                                                                                 “Momentium” (Werrick)

  8.               -do-            Lipitor 20mg          10’s   Rs. 1128.60   1. Rs. 190.00 per 10’s
                                   Atorvastatin                                  “Lipirex (Highnoon)

                                                                              2. Rs. 335.83 per 10’s
                                                                                 “Recol” (Barrett)

                                                                              3. Rs. 180.00 per 10’s
                                                                                 “Momentium” (Werrick)

  9.               -do-            Lipitor 40mg          10’s   Rs. 2019.60   1. Rs. 350.00 per 10’s
                                   Atorvastatin                                  “Lipirex (Highnoon)

                                                                              2. Rs. 340.00 per 10’s
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                                                                                    “Momentium” (Werrick)

  10.       M/s. Aventis           Tarivid 200mg              10’s   Rs. 296.79     Rs. 100.00 per 10’s
             Pharma,               (Ofloxacin)                                      “Oflobid” (Hilton)
             Karachi
  11.           -do-               Tarivid Infusion       100ml      Rs. 768.77     Rs. 140.00 per 100ml
                                   (Ofloxacin)                                      “Oflobid” (Hilton)

  12.        M/s. Bayer,           Ciproxin 100mg             6’s    Rs. 84.90
              Karachi              (Ciprofloxacin)

  13.              -do-            Ciproxin 250mg         10’s       Rs. 286.76   1. Rs. 90.00 per 10’s
                                   (Ciprofloxacin)                                   “Ciprok” (Swiss)

                                                                                  2. Rs. 95.00 per 10’s
                                                                                     “Ciprobact” (Mediceena)

  14.              -do-            Ciproxin 500mg         10’s       Rs. 504.60   1. Rs. 160.00 per 10’s
                                   (Ciprofloxacin)                                  “Ciprok” (Swiss)

                                                                                  2. Rs. 160.00 per 10’s
                                                                                     “Ciprobact” (Mediceena)

  15.              -do-            Ciproxin Infusion      100ml      Rs. 971.62   1. Rs. 150.00 per 100ml
                                   (Ciprofloxacin)                                   “Ciprok” (Swiss)

                                                                                  2. Rs. 150.00 100ml
                                                                                    “Ciprobact” (Mediceena)

  16.        M/s. Roche,           Rocephin 250mg Inj.        Vial   Rs. 141.40   1. Rs. 55.00 per vial
              Karachi              (Ceftriaxone)                                    “ Ronil” (Tabros)
                                                                                  2. Rs. 59.50 per vial
                                                                                     “Titan” (Macter)
                                                                                  3. Rs. 58.00 per vial
                                                                                     “Oxidil” (Sami)



  17.              -do-            Rocephin 500mg Inj.        Vial   Rs. 242.75   1. Rs. 95.00 per vial
                                   (Ceftriaxone)                                    “ Ronil” (Tabros)

                                                                                  2. Rs. 99.90 per vial
                                                                                     “Titan” (Macter)

                                                                                  3. Rs. 100.00 per vial
                                                                                     “Oxidil” (Sami)

  18.              -do-            Rocephin 1gm Inj.          Vial   Rs. 477.68   1. Rs. 148.00 per vial
                                   (Ceftriaxone)                                     “ Ronil” (Tabros)
                                                                                  2. Rs. 149.90 per vial
                                                                                     “Titan” (Macter)
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                                                         22
                                                                                      3. Rs. 190.00 per vial
                                                                                        “Oxidil” (Sami)

  19.              -do-            Rocephin 2gm Inj.            Vial    Rs. 1112.71     Rs. 450.00 per vial
                                   (Ceftriaxone)                                        P.R.C Price

  20.           M/s.               Voltral 25mg Tab             30’s     Rs. 94.18      Rs. 34.56 per 30’s
               Novartis,           (Diclofenac)                                         “Diclozaf” (Zafa)
               Karachi
  21.            -do-              Voltral 50mg Tab             20’s    Rs. 100.80      Rs. 45.36 per 20’s
                                   (Diclofenac)                                         “Diclozaf” (Zafa)

  22.              -do-            Voltral SR Tab               30’s    Rs. 295.58      Rs. 111.24 per 30’s
                                   (Diclofenac)                                         “Diclozaf” (Zafa)

  23.              -do-            Voltral 75mg Inj.            1x5’s   Rs. 119.10      Rs. 32.00 per vial
                                   (Diclofenac)                                         “Diclozaf” (Zafa)



                     There are also molecules which have less prices so that it is not possible for the
manufacturers to manufacture these products. Which also needs increase in prices on the basis of
actual costing based on ground realities. There are a number of molecules including the above-
mentioned drugs, which are directly sold in the open market on cut prices, or bonuses are offered
to attract the customer, which also reflects the great variation in the sale price and maximum
retail price. Such practices indicate misunderstanding among the masses.


                     The Chairman CL & RB has been repeatedly asking Pharma Bureau and PPMA
to cooperate for rationalization of prices based on actual costing but no results could be achieved
until the matter was taken up by the honourable Supreme Court of Pakistan. To streamline the
pricing system following proposals are submitted for consideration to build up recommendations
to the Federal Government:-
Decision:
Recommendations To Rationalize The Drug Prices.
                                Following recommendations were approved by the CL & RB to the
government for rationalization of prices:-


                                a.         A formula should be defined for the calculation of
                                           maximum retail price of drug formulations for locally
                                           manufactured and imported drugs and the same may be
                                           notified in the official gazette. However, the maximum
                                           retail prices should be fixed considering regional and
                                           international prices.
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                                                           23
                                b.         Prices of essential classes of drugs molecules /
                                           formulations recommended by PRC after further
                                           verification based on merits shall be notified as ceiling
                                           prices for those molecules and all the firms shall adopt
                                           these ceiling prices including those firms whose prices
                                           were fixed before the functioning of PRC.

                                c.         Prices of patented molecules / brand leaders may be re-
                                           fixed whose patents have been expired with 15% addition
                                           to the price fixed by PRC for that molecule or
                                           formulation.

                                d.         A committee may be constituted consisting of member
                                           from PPMA, Pharma Bureau and DDG (Pricing) headed
                                           by Cost Accountant, Ministry of Health which shall
                                           identify the hardship cases based on costing data for
                                           rationalization of these prices.

                                e.         To harmonies and monitor the franchising and trading
                                           practices, prices of drugs will be fixed separately by
                                           deducting the promotional expenses including the
                                           retailers discount, distributors discount and the salaries of
                                           the field staff. This will generate third category of
                                           products in the pricing structure and the maximum retail
                                           prices would be reduced by deducting above discounts
                                           and its beneficiaries will be patients instead of
                                           prescribers, retailers and / or both.

5.                   Unethical Marketing Practices.


                     The apex court has also taken notice of the unethical practices specially foreign
trips, bribing in the form of material gifts and other measures which are taken up by the Pharma
industry       used for the generation of prescriptions Schedule G of Rule 30 (11) of Drugs
(Licensing, Registering & Advertising) Rules, 1976 contains ethical criteria for the promotion of
pharmaceutical products. This has been circulated to all the stakeholders for compliance.
Meanwhile two cases of unethical promotion have been identified through complaints received
from Pulse International published from Karachi and Syed Adnan Ali Shah.
                     i.     A complaint was received from Dr. Syed Adnan Ali Shah which was
                              addressed to the honourable Minister for Health. It was indicated
                              that M/s. Shaigan Pharmaceutical, Islamabad is involved in unethical
                              practice of sending doctors on overseas trips in the name of
                              professional education. However, the letter to the doctor and the
                              itinerary of visit does not indicate any educational or professional
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                                                         24
                              activity, during the doctor visit to Kula Lumpur. It was also
                              mentioned that not only the doctor but their families were
                              encouraged to benefit the trip by a companying doctors. Copy of
                              letter issued by M/s. Shaigan vide letter No. Shaigan /0440/02/06
                              dated, 28th February, 2006 containing the schedule of trip was
                              enclosed by the complainant. This was send by Director Marketing
                              and Sales Mr. M. Amir Khan and Dr. Shahzad Shafique business
                              unit manager of the firm. A notice was issued to the firm getting
                              explanation M/s. Shaigan has replied through their reference No.
                              Shaigan / 0912/04/06 dated, 24th April, 2006 stating that they are an
                              ethical company and prominent exporters of the pharmaceuticals.
                              They have stated that it is in accordance with an international norm
                              and practice that any company having the ambitions to expand has to
                              reveal its international presence by (i) participating in international
                              scientific seminars and conference (ii) interacting with the medical
                              professionals / health authorities of the World. This helps to build
                              the company’s image and also aids in marketing its products in
                              future. This is also evident from the existing practices of MNC s
                              when they invite the foreign experts / speakers in the process of
                              registration of their products as well as upon the launch of new
                              products. In case of tour to Malaysia, the purpose was similar and
                              the visit was merely a pre launch activity focusing on our new
                              product “Zextra” (Gatifloxacin) in ASEAN countries, where the
                              leading doctors from ASEAN and African Countries exchanged their
                              experience. They have further stated that as far as unethical practices
                              are concerned, they are commonly prevailing in the market such as:-
                           a) Very heavy discounts

                           b) Policy of buy 100 units and get 100 free
                           c) Different buying schemes associated with the gifts of cars /
                              Acs etc.

                     ii. A similar complaint was received from Pulse International fortnightly
                              published from Karachi against the unethical marketing practices of
                              M/s. Searle Pharmaceutical, Karachi. In this complaint Chief Editor
                              wrote a letter to the M.D. of M/s. Searle, Karachi and endorsed

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                                                         25
                              copies to the Director General (Health) and Drugs Controller. M/s.
                              Searle defended the trip to Malaysia stating that the purpose was
                              disseminating knowledge amongst our customers and disease
                              awareness programmes. A notice was issued to the firm for violation
                              of ethical criteria in Schedule G leading to the violation of condition
                              of registration but the firm failed to response.


                     Representatives of the both firms are called for personal hearing.


Decision:            Representatives of the both firms appeared and defended their conduct. However,
it was decided that both the firms did not replied to the relevant queries of the Ministry of Health
it was directed that both firms shall submit the following information within one week.


                     i.         List of doctors sent for trips to Malaysia.
                     ii.        Purpose of trips along with its details and proofs.
                     iii.       Papers and other articles presented in the claimed conference / seminar.
                     iv.        Detail of charges / expenses incurred in this behalf.
                     v.         Invitation letters and copies of tickets / bills of the trips.
                     vi.        Total expenses done during the period of trips including the
                                representatives of the firms expenses in the said trips.
                     vii.       Detail of expense sheets of similar activities taken by the firm.
                     viii.      Detail of total marketing expenses in the financial year, 2005-06.


6.                   Illegal Advertisement


                     The honourable Supreme Court of Pakistan also noticed illegal advertisement
containing such shameful statements that these could not be studied in the families. The Federal
and Provincial Inspectors have been directed for taking cognizance of such practices under
Section 24 of Drugs Act, 1976 and rules framed there under. Suggestions are invited for effective
implementation.


Decision:            It was decided that the Provincial and Federal Inspectors of Drugs should be
activated to monitor and control the violations of Section 24 of Drugs Act, 1976. It was also
decided that the PEMRA should be asked to control the electronic media from the violation of

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                                                           26
Section 24, which is happening through electronic media especially cables. The Board decided to
direct the field force and addresses of cable licenses should be obtained from the PEMRA to
investigate the cases and collect evidences.




7.                   Illegal Prescribing behaviour


                     It was also brought to the notice of apex court that prescriptions of multiple drugs
in irrational manner is painful practice in our country. The Ministry o f Health is in process of
holding meetings with the Pakistan Medical Association and other stakeholders to create
awareness among the prescribers. In addition to creating awareness through seminars and
professional magazines. Suggestions are requested for making effective output.


Decision:            It was decided that international guidelines should be adopted to discourage the
poly pharmacy which is prevailing in the country. It was also recommended that the Provincial
Health Departments should be requested to co ntrol the quackery, which is the major source of
launching irrational prescriptions. Observer from the Network assured his maximum cooperation
in this respect.
8.                   National Essential Drugs List.


                     National formulary has been devised in consultation with Provincial governments
keeping in view of the WHO essential drugs list. Honourable members may contribute
suggestions in this regard.


Decision:            National formulary finalized in consultation with the Provincial Health
Authorities should be published.


9.                   Shortage of Drugs


                     Some of the essential drugs which are also cheap in Pakistan are smuggled to
neighbouring countries resulting in shortage for the local population. Taking into consideration
the hardship cases the prices of some formulations were revised for improvement in availability.
But some complaints are still existing about the non availability. Ministry of Health also granted
registration to local firms to meet the challenge of shortages and a number of local brands have

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                                                      27
been added. The Chairman CL & RB with his personal efforts have been contacting the relevant
firms including Pharma Bureau and PPMA representatives and meetings were also conducted to
improve the situation. It is important to mention that the manufacturing firms are legally as well
morally bound to ensure the adequate availability throughout the country.


Decision:            The measures taken by the Ministry of Health improved the availability of orphan
drugs. However, the major problem faced is that those drugs, which are light in weight and are
expensive in neighbouring countries are smuggled to these countries which creates problems to
the local consumer. The recommendations for change in sale only through the distributors having
authority letters will lead to improvement and any malpractices will be traceable because newly
proposed warranty form, authority letter and amendment will restrict sales to the unauthorized
wholesalers who collect these drugs and export to neighbouring countries.


Item No. IV
                     CORRELATION    BETWEEN    CONTRACT   MANUFACTURING
                     PERMISSION AND NEED OF THE COUNTRY IRRESPECTIVE OF
                     SOLE BUSINESS APPROACH AS WELL AS INSPECTION PANELS
                     FOR CONTRACT MANUFACTURING.

                     Central Licensing & Registration Board          finalized   policy for contract
manufacturing of drugs in its 195th meeting. In the policy inspections panels were also approved
consisting of five members three from the Ministry & Registration Board and one each from
PPMA and Pharma Bureau but both the stakeholders are reluctant to engage their experts in
inspections although the proposal of five members panel came through Mr. Zafar Mooraj of
Pharma Bureau. At the same time it has also been observed that applications pending or freshly
submitted for contract manufacturing permission are consisting of mainly following classes of
drugs, whether needed or already abundant brands are available:-
                     o Cephalosporins in oral and injectable dosage forms
                     o Quinoloes like Ofloxacin, Ciprofloxacin and Levofloxacin and others.
                     o Macroloids like Roxithromycin, Clarithromycin etc.


                     The contract manufacturing permission of these molecules and other drugs
already being manufactured by a large number of firms is not justified due to following reasons:-


                           1. Large number of brands and generics are available in the
                              market.

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                                                     28
                            2. The firms who have invested in creating specialized unit
                               are suffering as compared to those getting contract
                               manufacturing with out investing any peny.

                            3. Unhealthy competition leading to unethical marketing
                               practices through franchisers is prevailing in the market
                               creating troubles, both for the competitors and patients with
                               unneeded and faced prescription generation.

                            4. The franchised promotion is also contributing towards the
                               spurious manufacturing attitude.

                     The honourable Board may recommend classes of drugs allowed for
manufacturing through contract permission.

Decision:     It was decided that contract manufacturing permission for the following groups
shall be immediately stopped:-


                     i.         Cephalosporins in oral and injectable dosage forms
                     ii.        Quinoloes like Ofloxacin, Ciprofloxacin and Levofloxacin and others.
                     iii.       Macroloids like Roxithromycin, Clarithromycin etc.

                     The matter shall be placed in the forthcoming meeting for further discussion.

Item No. V

                     NUMBER OF GENERICS AND BRANDED FORMULATIONS OF A
                     PARTICULAR DRUG MOLECULE AND NEED OF THE COUNTRY.


                     Number of registrations is touching to the figure of 40,000 registered drugs which
is second highest in the region after India. The members of the Registration Board always
showed there concern about the number of registration granted to various firms leading to
problems. It is required to formulate a strategy leading to result oriented approach keeping in
view the benefit of stakeholders as well as poor masses.:-
                      Maximum number and temptations registrations for a molecule
                       of drugs.
                      Creating awareness towards basic manufacturing instead of
                       formulation industry.
                      Other measures to improve the system.

Decision:            Deferred due to paucity of time.



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                                                        29
Item No. VI

                     CHANGE OF NAME OF ALREADY REGISTERED DRUGS.


                     The name of change of already registered drugs has become practice for a number
of firms resulting in problems for the regulatory authority. Keeping in view the experience of
“Lozone & Zezone” Injections it is proposed that there should be complete ban on the change of
name except the following reasons:-


                    The change of name of registered drugs shall be permissible only within 6 months
                     after the registration of drugs.
                    After this period there shall be no change but only if similarities of brand name is
                     originated.
                    In case of branded products if there is change in name at international level.


Decision:            It was decided that the change of name of a registered drugs should be allowed
only within six (6) months after the registration of drugs. After six months no change will be
allowed.



Item No. VII

                     LISTS OF REGISTERED DRUGS BOTH MANUFACTURED AND NOT
                     MANUFACTURED BY THE FIRMS.


                     The Central Licensing & Registration Board has been showing its regular concern
about the total number of registered drugs, number of drugs being manufactured b y the firms and
number of drugs not being manufactured by the firms. In the last meeting of Board concerned
Officers of DCA, Karachi, Lahore, Peshawar, Islamabad were called upon in the Board meeting
and it was decided that complete lists will be provided within one month period. It was also
decided that PPMA and Pharma Bureau will coordinate their members for submission this
information on prescribed forms as it is the condition of registration but uptil now only firms as
shown in has submitted list.




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                                                        30
S. No.                Name of firm            No. Of registered   No. Of drugs being   No. of drugs not
                                                   Drugs            Manufactured       Manufactured
  1             M/s.Atco Laboratories               157                   142                 15
                    Ltd, Karachi

  2              M/s. AGP(pvt) Ltd,                 228                   76                 152
                        Karachi.
  3           M/s.BSN Medical (Pvt)                  08                   05                 03
                      Ltd, Karachi
  4          M/s. Catts Pharmaceutical               09                    -                  9
                   (pvt)Ltd Karachi.
  5                  M/s.Eli Lilly-                  03                   03                 Nil
              Gohar(pvt)Ltd, Karachi
  6                   M/s. Macter                   165                   138                27
               International(Pvt) Ltd,
                        Karachi
  7.          M/s. Glaxo Smith Kline                158                   151                 7
               Pakistan Ltd, Karachi.
  8.           M/s. Organon Pakistan                 52                   45                 07
                  (Pvt ) Ltd Karachi
  9.             M/s.Parke-Davis &                   30                   23                 07
              Company Ltd, Karachi.
 10.          M/s.Pfizer Laboratories                43                   33                 10
                      Ltd, Karachi
 11.            M/s. Barrett Hodgson                188                   128                60
                  Pakistan (Pvt) Ltd,
                        Karachi.
 12                  M/s. Brookes                   139                   54                 85
                    Pharmaceutical
             Laboratories,(Pvt) Karachi.
 13          M/s. Wyeth Pakistan Ltd.,              121                   76                 45
                        Karachi
 14             M/s. Searle Pakistan                141                   130                11
                    Limited Karachi
 15                    M/S Bayer                     60                   27                 33
             Pharmaceuticals, Karachi.
 16            M/s Karachi Chemical                  82                   63                 19
                 Industries, Karachi.
 17          M/s S.J & G. Fazul Ellahie,            114                   87                 27
                        Karachi.
 18            M/s Epla Laboratories                115                   77                 38
                 (Pvt) Ltd, Karachi.
 19             M/s Spencer Pharma,                  83                   38                 45
                        Karachi.
 20           M/s W. Woodward (Pvt)                  52                   39                 13
                     Ltd, Karachi.


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                                                       31
Decision:            Data obtained from the Provinces through FIDs was placed before the Board and
Chairman took notice about the lack in interest by the concerned Officers because except
Peshawar all other offices failed to comply the instructions of the Board. Similarly manufacturers
reflected irresponsible behaviour. The Board directed that all the regional offices of DCA shall
submit consolidated data within 10 days and consolidated report shall be submitted in the 10 th
June, 2006 schedule meeting of the Board.

Item No. VIII
                     PRICING OF DRUGS OF VARIOUS CATEGORIES, WHICH FALL
                     UNDER THE CATEGORY OF NEW APPLICATION FOR
                     REGISTRATION.

                     According to Schedule F note D it is stated that
                     “ an application for :-
                     1.       Transfer of registration from one importer or manufacture to
                              another.

                     2.       Transfer from import to local manufacture.

                     3.       Import in bulk and repacking locally, and
                     4.       Change of name of registered drug.
                     5.
                     6.       Re-registration after expiry of validity of registration shall be
                              considered as for the grant of new registration & shall be
                              made as per rule 26(1)of Drugs Licensing Registering &
                              advertising 1976.

                     All the above categories will fall under the fresh applications for registration &
accordingly latest prices recommended by PRC & approved by the federal Govt. shall be
applicable instead of prices already applicable at the time of original registration. This is on the
ground that all manufacturers applying for registrations of various molecules are being granted
prices recommended by the PRC on uniform basis.


Decision:            Deferred due to paucity of time

Item No. IX
                     TREATMENT OF RAW MATERIAL OF                                     “   METAMIZOLE”
                     DEREGISTERED BY REGISTRATION BOARD.

                     Reference to withdrawal / cancellation of registration of drugs formulations
containing “Metamizole” deregistration letters were issued to the firms and field Officers of
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                                                          32
Federal Drugs Control Administration and Provincial Health Departme nts were requested to
implement the decision in true in spirit. They were also directed to seize the raw material /
packing material of these drugs. Federal Inspectors of Drugs, Lahore have reported that M/s.
Munawar Pharma, Lahore, M/s. Ideal Pharmaceutical Labs, Lahore and M/s. Dosaco
Laboratories, Lahore were having following quantities of packing material / raw material of
“Metamizole” along with quantities of finished drugs containing “Metamizole”.

Decision:            Deferred due to paucity of time



Item No. X

                     POLICY FOR HVAC SYSTEM


                     The Minister for Health has kindly approved the following policy for installation
of HVAC systems.

                     i.         Relaxation of installation of HVAC system for two years i.e. till December,
                                2007 have been approved only for the existing manufacturing facilities
                                subject to fulfillment of the following conditions:-

                                 Submission of S.O.Ps for cleaning validation and their
                                  implementation.

                                 Submission of campaign manufacturing schedule for
                                  complete year.

                     ii.        However, for the grant of new manufacturing licenses as well as new
                                sections HVAC system will remain a prerequisite.
                     iii.       Similarly for the grant of new registrations HVAC system shall also remain
                                a prerequisite. No registration will be granted to the firms availing
                                relaxation of HVAC system until they install it.

                     For information as the same has been circulated to the stakeholders and regional
offices of DCA.


Decision:            Deferred due to paucity of time




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                                                          33
Item No. XI
                     DELEGATION OF POWERS DURING VARIOUS BOARD MEETINGS.


                     Following powers of day to day working have been delegated to the Chairman CL
& RB, Drugs Controller and DDG (Registration) to expedite the working avoiding pendencies.
These powers are revalidated under Section 7 (7) of Drugs Act, 1976 for the above purpose:-


S. No. Name of Authority Delegated                                      To Whom Delegated

  1.        Re-registration of drugs which were declared no more         Chairman CL & RB
            valid due to late submission of renewal applications.

  2.        Transfer of Registration from one manufacturer to other             -do-
            manufactures.

  3.        Approval for registration of drugs for export purpose               -do-

  4.        Approval for Change in formulation of registered drugs              -do-

  5.        Issuance of show cause notices for GMP violations                   -do-

  6.        Issuance of show cause notices for cancellation of                  -do-
            registration of drugs

  7.        Issuance of show cause notices for cancellation of                  -do-
            manufacturing licenses.

  8.        Grant of registration of drugs for emergency purpose in             -do-
            cases of public threats.

  9.        Change in contract manufacturer for the period                      -do-
            approved by the Board
  10.       Grant of renewal of registration for the already                    -do-
            registered drugs

  11.       Constitution of Inspection panels                             Drugs Controller
                                                                           (Registration)

  12.       Approval for Change in inactive ingredients of drugs                -do-

  13.       Nomination of experts of various specialties                        -do-

  14.       Change of name of similar drugs within one year after               -do-
            initial registration

  15.       Approval of packaging material                               DDG (Registration)


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                                                   34
  16.       Grant of permission for registration of F.I.R.                  1. In case of spurious
                                                                            drugs manufacturing and
                                                                            without license drugs
                                                                            manufacturing concerned
                                                                            F.I.Ds are authorized for
                                                                            registration of F.I.R.

                                                                            2. For rest of the
                                                                            cognizable cases DC/ QC
                                                                            are authorized for granting
                                                                            permission for registration
                                                                            of F.I.R.

  17.       Grant of permission for extension in not to dispose of                     DC / QC
            period.

  18.       Grant of permission for extension in sealing period                         -do-

  19.       Grant of permission for extension in testing period.                        -do-

  20.       Grant of registration of Me-Too drugs                           Chairman CL & RB after
                                                                            the approval of Me-Too
                                                                            Committee constituted by
                                                                            the government under the
                                                                            recommendation of CL &
                                                                            RB.

Decision:            Deferred due to paucity of time


 Item No. XII
                     MISCELLANEOUS CASES AND OTHER MATTERS RELATED TO
                     IMPORT AND LOCAL MANUFACTURING DRUGS REGISTRATION.

Case No. 1           DDG (E&M), DCA, and Federal Inspector o f Drugs, Karachi have submitted the
inspection report of following firms for verification of HVAC system and confirmed the HAVC
system installation. Following cases of relevant firms were considered in 193-A & 195-A Me-
Too Committee meetings constituted by Drugs Registration Board for confirmation of HVAC
system of following drugs:-


        S. No.        Name of              Name of Drug(s) & Composition      Pack        Demanded
                       Firm(s)                                               Size(s)        Price
            1.        M/s. Indus           Levex 500mg Tablets                10’s        Rs. 740.00
                       Pharma,             Each tablet contains:-
                       Karachi             Levofloxacin……500mg
                                           (Fluoroquinolone Antibacterial
                                           agent)
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                                                             35
            2.              -do-           Oflox 200mg Injection                    1’s       Rs. 692.00
                                           Each 100ml contains:-
                                           Ofloxacin (as Ofloxacin
                                           Hydrochloride)……..200mg

            3.       M/s. Genix            Borovate Cream                            5g       Rs. 12.50
                      Pharma,              Each 100mg contains:-                    15g       Rs. 32.00
                      Karachi              Betamethasone Dipropionate (eq.
                                           to Betamethasone Basa)
                                           ……0.525gm
                                           (Betamethasone (Valerate)


            4.      M/s. Bosch Lokit Injection                                    Per vial      150.00
                    Pharmaceuti Each vial contains:-
                    cal, Karachi Pantoprazole Sodium 44.39mg eq.
                                 to Pantoprazole …………..40mg
                                 (Proton Pump Inhibitor)


            5.              -do-           Toptic-D Ophthalmic Eye Drops           5ml        Rs.105.00
                                           Each ml contains:-
                                           Tobramycin as Sulphate .3.15mg
                                           eq. to Tobramycin………..3mg
                                           Dexamethasone…...3mg
                                           (Antibacterial)

            6.              -do-           Clopred Eye Drops                       10ml        Rs.28.00
                                           Each ml contains:-
                                           Prednisolone……….1.24mg
                                           Chlorphenicol………3mg
                                           (Antibacterial, Anti- inflamatory)


Case No. 2           Following drugs were deferred for inspection in various meetings of Drugs
Registration Board for verification of production and quality control facilities of M/s. Macter
International, Karachi. The grant of registration to the firm was halted on the basis of adverse
inspection report by the panel of inspectors on the basis of various observations. Now a fresh
panel was constituted by the MoH consisting of following members:-


                     i.         Mr. Abdul Latif Shaikh                    Member (CL & RB)
                     ii.        Dr. Ali Akbar Sial,                       DDG (E&M), DCA, Karachi
                     iii.       Mr. Ahmed Din Ansari                      Federal Inspector of Drugs
                     iv.        Mr. Obaid Ali                             ADC, CDL, Karachi
                     v.         Mrs. Roohi Obaid                          ADC, DCA, Karachi

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                                                             36
                The panel have recommended the grant of registration of the following products:-
                 S. No.    Name of product(s)                  Proposed   Proposed
                                                                 pack       Price
                   1       Clop Tablets                         10x2’s     As per
                           Each tablet contains:-                           leader
                           Ticlopidine HCl…….250mg                           price
                           (Cardiovascular)

                   2       Mitake Tablets 20mg                  1x10’s     As per
                           Each tablet contains-                           leader
                           Atorvastatin (as Calcium                         price
                           Trihydrate salt)……….20mg
                           (Lipid regulating agent)
                   3       Dinot Tablets 4mg                    1x10’s    Rs.41.35
                           Each tablet contains:-               2x10’s    Rs.79.50
                           Candesartan
                           Cilexitel…………….4mg
                           (Cardiovascular drug)

                   4       Dinot Tablets 8mg                    1x10’s    Rs.62.00
                           Each tablet contains:-               2x10’s    Rs.120.28
                           Candesartan
                           Cilexitel………..….8mg
                           (Cardiovascular drug)

                   5       Dinot Tablets 32mg                   1x10’s    Rs.183.69
                           Each tablet contains:-               2x10’s    Rs.356.36
                           Candesartan
                           Cilexitel…………32mg
                           (Cardiovascular drug)

                   6       Hart Tablets 3.125mg                 1x10’s     As per
                           Each tablet contains:-                          leader
                           Carvedilol……..3.125mg                            price
                           (Cardiovascular drug)

                   7       Hart Tablets 6.25mg                  1x10’s     As per
                           Each tablet contains:-                          leader
                           Carvedilol……..6.25mg                             price
                           (Cardiovascular drug)

                   8       Hart Tablets .12.5mg                 1x10’s     As per
                           Each tablet contains:-                          leader
                           Carvedilol……...12.5mg                            price
                           (Cardiovascular drug)

                   9                Starel Tablets 20mg        3 x 10’s    As per
                                    Each tablet contains:                  leader
                                    Trimetazidine                           price
                                    dihydrochloride………..20mg
                                    (Cardiovascular drug)
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                                                          37
                         10         Zetim Tablet                    10’s     Rs.719.06
                                    Each tablet contains:         2 x 10’s   Rs.1429.52
                                    Ezetimibe ……………10mg
                                    (Cardiovascular drug)

                         11         Stat Capsules                  10’s      Rs.2224.18
                                    Each tablet contains:
                                    Orlistat………..120mg
                                    (Cardiovascular drug)


                         12         Cardionase Injection 1.5       Vail      Rs.8700.00
                                    Each vial contains:
                                    Recombinate
                                    Streptokinase……1.5MIU
                                    (Fibrinolytic)



Decision:            Deferred due to paucity of time



Case No. 4           M/s. A.G.P, Karachi has applied for the transfer of registration from import in
finished form to local manufacturing. Presently these drugs are registered for M/s. Eli Lilly,
Pakistan who are importer. M/s. A.G.P. also requested for contract manufacturing permission of
these product from M/s. Eli Lilly Gohar, Karachi.:-


                        S. No.        Name of product(s)         Proposed    Proposed
                                                                   pack        Price
                           1          Ceclor MR 375mg Tablets.
                           2          Ceclor MR 500mg Tablets.
                           3          Ceclor MR 750mg Tablets.


                     For want verification of dedicated facilities of M/s. Eli Lilly Gohal a panel was
approved for inspection consisting of the following members:-
                     i. Dr. Ali Akbar Sial                         DDG (E&M) DCA, Karachi
                     ii Mr. Ahmed Din Ansari                       Federal Inspector of Drugs
                     iii Mrs. Roohi Obaid                          Assistant Drugs Controller


                     The panel was requested to evaluate the following parameters in addition to
dedicated facilities:-


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                                                           38
                     i.   Installed capacity of M/s. Eli Lilly Gohar, Karachi in the
                          “Cephalosporin” area.
                     ii. Actual capacity of the area.
                     iii. Utilized capacity of the area.

                     Now the panel has recommended for approval the above mentioned drugs on the
grounds that the plant is already under utilized (as per statement of the management) and they
have Good Manufacturing and Q.C facilities for the manufacture of above mentioned drugs.
Decision:            Deferred due to paucity of time

Case No. 5          Following drugs were deferred in 196th meeting of Drugs Registration Board

   S. No.          Name of                 Name of drug(s) & Composition         Pack     Demanded
                   Firms(s)                                                     Size(s)      Price
      1.          M/s Aventis              Tritace 10mg Tablets                  10’s     Rs. 1252.00
                   Pharma,                 Each tablet contains:-
                   Karachi                 Ramipril ……….10mg
                                           (ACE Inhibitor)

                                           (Import in bulk from Aventis
                                           Pharma, Italy and repacked
                                           locally)

      2.           M/s. Bayer              Trasylol Infusion Solution            50ml     Rs. 4,056.00
                   Pakistan,               Each vial contains:-                 100ml     Rs. 7,701.77
                    Karachi                Aprotinin concentrated solution      200ml     Rs. 13,472.07
                                           corresponding to:
                                           In Sterile Isotonic Sodum Chloride
                                           Solution………..500,000 KIU,
                                           1000,000 KIU & 2000,000 KIU

                                           (Import in bulk from M/s. Bayer
                                           HealthCare    AG    Leverkusen,
                                           Germany and repacked locally)

      3.          M/s. Zafa                Artesul Tablets for adults           1x9’s      Rs. 105.00
               Pharmaceutical,             Each small tablet contains:-
                   Karachi                 Artesunate……..100mg
                  Mfg. Lic.                Each large tablet contains:-
                   000513                  Sulfadoxine…………500mg
                                           Pyrimethamine……….25mg
                                           (Anti-Malarial)
      4.                  -do-             Artesul Tablets for adults           1x8’s       Rs. 60.00
                                           Each small tablet contains:-
                                           Artesunate……..50mg
                                           Each large tablet contains:-
                                           Sulfadoxine…………500mg
                                           Pyrimethamine……….25mg
                                           (Anti-Malarial)
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                                                            39
          Decision:             Deferred due to paucity of time

Case No. 6           Following drugs of M/s. PharmEvo, Karachi were deferred for expert evaluation
but now the firm has requested that these drugs are already registered to various firms:-
                  S. No.         Name of Drug (s) & Composition     Pack     Demanded
                                                                   Size(s)     Price
                       1         Cerizine D Capsule                1x10’s     Rs.60.00
                                 Each capsule contains:
                                 Cetirizine dihydrochloride
                                 pellets ………………. 5mg
                                 Pseudoephedrine pellets….120mg
                                 (Antiallergic)

                       2         Mover Tablets                      10’s     Rs.16.00
                                 Each tablet contains:-             20’s     Per tablet
                                 Glucosamine Sulphate...500mg
                                 Chondroitin Sulsphate …200mg
                                 Calcium Carbonate …75mg
                                 Vitamin C ……….. 25mg
                                 (Anti Arthritic)

                       3         Estar 5mg Tablets                 1x10’s    Rs.260.00
                                 Each tablet contains:-
                                 Escitalopram (as Oxalate)….5mg
                                 (Anti depressant)

                      5          Estar 20mg Tablets                1x10’s    Rs.950.00
                                 Each tablet contains:-
                                 Escitalopram (as Oxalate)….20mg
                                 (Anti depressant)


Decision:            Deferred due to paucity of time




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                                                        40
                                                                  TH
        EXTRACT TAKEN FROM MINUTES OF 197                              MEETING OF DRUG
                REGISTRATION BOARD HELD ON 3 RD –4TH MAY, 2006
                                           (REG-II-SOUTH).

          ANY OTHER ITEMS WITH THE PERMISSION OF CHAIRMAN CL & RB

Me-Too Committee

                     During the meeting it was pointed out that the applications for the registration of
following drugs shall not be submitted to Me-Too Committee for consideration and these
applications will be considered by the Registration Board.

                     1. Modified release and control release dosage forms.
                     2. All dosage forms of drugs for which dedicated facilities are required like
                        Pencillins, Cephalosporins, Hormones including Quinolones and Macroloids .
                     3. All classes of specialty drugs used for cardiovascular diseases.
                     4. Potent drugs.


                     Meeting ended with the vote of thanks to the chair.




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                                                     41
                                                                    TH
        EXTRACT TAKEN FROM MINUTES OF 197                                MEETING OF DRUG
                REGISTRATION BOARD HELD ON 3RD –4TH MAY, 2006
                                              (REG-II-SOUTH).

Decision:            It was decided that contract manufacturing permission for the following groups
shall be immediately stopped:-



                     i.         Cephalosporins in oral and injectable dosage forms
                     iv.        Quinoloes like Ofloxacin, Ciprofloxacin and Levofloxacin and others.
                     v.         Macroloids like Roxithromycin, Clarithromycin etc.

                     The matter shall be placed in the forthcoming meeting for further discussion.




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                                                        42
                                                                     TH
        EXTRACT TAKEN FROM MINUTES OF 197                                 MEETING OF DRUG
                REGISTRATION BOARD HELD ON 3 RD –4TH MAY, 2006
                                                (REG-II-SOUTH).

                     All the firms shall adopt the specifications mentioned in the
                     official pharmacopoeias for all the formulations except those drugs
                     not included          in the official pharmacopoeias. For these drugs
                     manufacturers may adopt their own specifications till the inclusion
                     of that formulation in the official pharmacopoeias. After this
                     decision firms will not be allowed to adopt their own specifications
                     for the drugs, which are included in any of the official
                     pharmacopoeias, listed in the Section 3 of Drugs Act, 1976.




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                                                          43

				
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