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MINUTES OF THE 192ND MEETING OF THE REGISTRATION BOARD HELD ON 6th August, 2005, (LOCAL MANUFACTURE) SOUTH. The 192nd meeting of the Drug Registration Board was held on 6th August, 2005 in the Committee Room of the 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:- i. Maj. Gen. (R ). Nasir-ul-Islam Rawalpindi ii. Brig. Muzammil Hassan Najmi Prof. of Pharmacology & Therapeutics Army Medical College, Rawalpindi iii Prof. Dr. Muhammad Jamshaid Chairman Faculty of Pharmacy Punjab University, Lahore. iv Mr. Abdul Latif Sheikh, Director Pharmacy, Nutrition & CSSD Services, Agha Khan University Hospital, Karachi. v Dr. Ijaz Ahmed, Associate Professor University of Veterinary and Animal Sciences, Lahore. vi Animal Husbandary Commission Ministry of Food , Agriculture & Livestock Islamabad. vii Muhammad Saad Khan Deputy Secretary, Ministry of Law, Justice & Human Rights, Islamabad. xiii Director General Health Services Government of N.W.F.P, Peshawar ix Director General Health Services Government of Balochistan, Quetta x Deputy Secretary, M/o. Industries & Production, Islamabad xi Controller of Patents, Government of Pakistan, Karachi. xii Dr. Farnaz Malik (Also Secretary of the Board) Drugs Controller Ministry of Health Islamabad. Dr. Kausar Aamir, 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. Dr. M.H Siddiqi representative of Pakistan Pharmaceutical Manufacturers Association and Mr. M.Zafar Mooraj, representative of Pharma Bureau, Karachi also attended the meeting as observers. ITEM NO.I CONFIRMATION OF THE MINUTES OF THE 191ST MEETING HELD ON 30TH AND 31ST MAY, 2005. Minutes of the 191st meeting which had been circulated to all members of the Board for comments/ views/ observations were approved unanimously by the Board. ITEM NO.II-A CANCELLATION OF REGISTRATION OF METAMIZOLE CONTAINING PRODUCTS. The Drug Registration Board in its 189th meeting had decided to review all the cases of oral formulation containing “Metamizole” which are already registered and issue show cause notices for cancellation of these registrations due to the reason it is associated with an increase risk of agranulocytosis and with shock. Accordingly show cause notices for cancellation of already registered formulations containing Metamizole were issued. It is mentioned here that WHO - Essential Drugs and Medicines – Quality Assurance and Safety of Medicines, Switzerland had published a list of countries i.e Armenia, Colobia, Morocco, Sweden, Syria, Yemen and Zimbabwe where Metamizole has been suspended / cancelled. A list of products containing Metamizole and reply of the firms are as under:- S. No. Name of firm(s) Name of products Reg. No. Remarks of the Company 1. M/s Merck Sistalgin Compound Tablets 004157 M/s Merck Marker, Quetta has informed that due to an increase Marker, Quetta Each tablet contains:- risk of agranulocytosis and with shock they have stopped / Pramiverine …..2mg discontinued the production and commercialization of the Metamizol ……….250mg products, which include Dolo-Neurobion Injection & Tablets, Sistalgin Compound Tablets / Ampoule and Buscopan Compound since beginning of October, 2004. 2. -do- Sistalgin Compound Injection 004213 -do- Each 5ml ampoule contains:- Pramiverine ……………2.5mg Metamizol ……….2.25gm 3. M/s Aventis Novalgin Tablets 000235 M/s Aventis Limited, Karachi has submitted that being an Pharma, Karachi Each tablet contains:- ethical company they have a stringent internal audit system of Metamizole ………500mg suspected ADR reporting which analyses ever minor side effect occurring with their any marketed drugs. Very rare adverse reaction of agranulocytosis have been known for decades and communicated to healthcare professionals and patients. However no such incidence has been reported to them in Pakistan. They risks associated with Metamizole have been vastly studied and documented and the International Agranulocotosis and Aplastic Anemia Study (IAAAS) also known as the Boston Trials, a study conducted in 22 million patents in 1986 reported any excess risk of dipyron induced agranulocytosis as one case in 1.1milion users per week. Moreover may other analgesics including Acetaminophen, antibiotics including Penicillin and cephalosporins, diuretics including Acetazolamide and antimalarials including Amodiaquine and Hydroxchloroquine have been reported to have rare risk of angranulocytosis. The firm has requested that on the basis of information the use of Metamizole should be continued in Pakistan and also requested for personal hearing. 4. -do- Novalgin Syrup 000234 -do- Each ml contains:- Metamizole ………50mg 5. -do- Novalgin Injection 000232 -do- Each 2ml contains:- Metamizole ………50mg 6. M/s Elite Elpyron Injection 024865 M/s Elite, Lahore has submitted that as far as side effects of this Pharma, Lahore Each 2ml contains:- drug are concerned, many drugs currently being manufactured Metamizole Sodium DAB..500mg have side effects of one type or another, so the case of side effects is not limited to Metamizole only. Whereas the use of Metamizole is justified in serious or life threatening situation where no antipyretic is available or sutable and that too under the supervision of medical practioner. Prolonged or habitual use of this drug is certainly going to produce side effects and again this logic holds good for number of drugs rather majority of drugs currently being manufactured. In October, 2000 the Russian Ministry of Health that the Metamizole officially is not recommended for OTC (with out prescription) pharmacy sale to customers under 18 years old. They suggested that a study carrying out at University level before a decion is taken in this regard, since it iinvolves lot of controversy. Nevertheless, whatever is the decision of honourable Board, they shall abide by that decision. 7. -do- Hyoscine Compound Injection 022240 -do- 8. M/s Dosaco Dipyron Injection M/s Dosaco Labs., Lahore have informed that they are Labs, Lahore producing these formulations since 1977 and meet the requirement of the market. Since than they have not received any complaint about its adverse effect from any physician nor from any customer. In their opinion it is one of the safest and the most potent medicines. They have also added that they have 3 Tons of “Metamizole” in their godown and about 10 Tons are on the way for which they have already paid the amount in foreign exchange. They have also requested for giving them a chance of personal hearing. 9. -do- Hyoscine Compound Tablets 002697 -do- Each tablet contains:- Hyoscine – N- Butylbromide …..10mg Metamizole ………250mg 10. M/s Ideal Dipyron Tablets M/s Ideal Pharma, Lahore have furnished that in 1988 this Pharmaceuticals, matter of Metamizole containing drugs side effect like severe Lahore agranulocytosis came in the notice of Ministry of Health and that time firstly it was decided to replace “ Metamizole” with “ Paracetamol” but after collection of further information from the origin country Germany and on pressing demand of doctors it was decided to allow to continue this product. They have further added that technical side of this drug then like all the other drugs, Metamizole has its side effects. Major side effects of any drug appear after its overdose or after prolonged use and in that case that particular drug is replaced by another drug by the doctors. In combination with other anti- spasmodics like Hyoscine-N-Butylbromide it is a wonderful drug in the treatment of biliary and renal colic pains. In these conditions such type of combination is given to patients only for 2-3 days or whenever the pain appears again. There is no prolonged use of drug is given in such condition. Side effect like agranucytoris appear only when this drug is given in large dose or during prolonged therapy. In the last the firm have accepted the decision what so ever decided by the Board but they added here that before any final decision please do collect more and more technical information from the country of origin. 11. -do- Hyoscine Compoud Tablets 010158 -do- 12. M/s L.C.P.W., Dipyron Tablets M/s L.C.P.W., Lahore have informed as under:- Lahore i) withdrawal of registration containing Metamizole was take up by the Ministry of Health earlier in 1987 and after thorough consideration the Ministry of Health in 1988 withdrew the withdrawal of Metamizole preparation. No once again the matter has been probed up. ii) The drug „ Metamizole‟ is being used internationally throughout the world. iii) Dipyron / Metamizole is included in BP 2002 an is also included in the 4th Edition of European Pharmacopeia.. iv) There is no such compelling circumstance that all of a sudden to withdraw the Metamizole preparation just on the initiation of a company having vested interests to withdraw the medicine and to market another preperation with higher price for particular gains and the object is to increase to overburdened the ailing humanity. In the last the firm has requested for personal hearing so that the matter is thoroughly demonstrated that the withdrawal is neither legal nor justifiable. 13. -do- Hyospan Injection 003084 -do- Each 5ml ampoule contains:- Hyoscine – N- Butylbromide …..20mg Metamizole ………2.5gm 14. -do- Hyospan Compound Tablets 001750 -do- Each 5ml ampoule contains:- Hyoscine – N- Butylbromide …..10mg Metamizole ………250mg 15. M/s AGP, Magnopyrol Injection 002365 M/s AGP, Karachi have referred the discussion of Maj. Gen. Karachi Each 2ml contains:- Shujjat Hussain and submitted that he was very clear in his Phenyl Dimethyl-Pyrazolone Methyl- views that Metamizole Magnesium is therapeutically active Aminomethane magnesium sulphonate and has great clinical value and strongly recommended to 0.8gm maintain this drug in the list of registered drugs. They have requested that on the basis of above recommendation they were allowed to continue the manufacturing of these drugs. 16. -do- Magnopyrol Syrup 016914 -do- Each 5ml contains:- Phenyl Dimethyl-Pyrazolone Methyl- Aminomethane magnesium sulphonate 250mg 17. -do- Magnopyrol Tablets 002364 -do- Each tablet contains:- Phenyl Dimethyl-Pyrazolone Methyl- Aminomethane magnesium sulphonate 0.5gm 18. -do- Spaslar Capsules 013366 -do- Each capsule contains:- Hyoscine – N- Butylbromide …..10mg Metamizole ……..250mg 19. M/s Medicaids, Hyoscine Compound Tablets 003216 M/s Medicaids, Karachi have informed that they have already Karachi suspended the production and started working on a revised formulation deleting Metamizole. 20. M/s Wilshire Hyoscine Compound Tablets 010563 M/s Wilshire Labs, Lahore have full regard for opinion of Labs., Lahore Honourable Registration Board regarding side effects of Metamizole i.e Agranulaocytosis and submit the proposals (i) This Drug may be deregistered and registration fee adjusted against a new registration (ii) This formulation may be amended as Hyoscine-N-Butyl Bromide 10mg and Paracetamol 500mg 21. -do- Lospasm Tablets 010563 -do- Each tablet contains:- Hyoscine-N-Butyl bromide........10mg Metamizole Sodium..250mg 22. -do- Dipyron Tablets 008212 -do- 23. M/s Indus Nosgin Injection 011416 M/s Indus Pharma, Karachi have submitted that they are Pharma, Karachi Each 2ml contains:- exporting these formulations to Central Asian States is there is Fenpiverinium Bromide ..0.02mg big market for these drugs earned foreign exchange for the Pitofenone HCl …2mg country. They have added that Metamizole sodium its use is Metamizole Sodium………500mg justified as antipyretic in serious or life threatening situations where no alternative is available or suitable. They have requested to continue the registration of drugs containing Metamizole as active ingredient. 24. -do- Nosgin Tablets 015397 -do- Each tablet contains:- Fenpiverinium Bromide ..0.01mg Pitofenone HCl …5mg Metamizole Sodium………500mg 25. M/s Helix Spalin Injection 011637 M/s Helix Pharma, Karachi have agree with the decision and Pharma, Karachi Each 5ml ampoule contains:- requested for cancellation of their registrations. Hyoscine-N-Butyl bromide........20mg Metamizol ……….2.5gm 26. -do- Spalin Compound Tablets 002458 -do- Each tablet contains:- Hyoscine-N-Butyl bromide....10mg Metamizol ……….250mg 27. M/s Bloom Surfen Tablets 022362 M/s Bloom Pharma, Hattar has informed that as per instruction Pharmaceuticals, Each tablet contains:- they have ceased manufacturing of this product. However they Hattar Hyoscine-N-Butyl bromide....10mg have requested for replacement of Metamizole with Metamizol ……….250mg Paracetamol. 28. M/s Munawar Hyoscine Compound Injection 022933 Reply not received. Pharma, Lahore Each 5ml contains:- Hyoscine N Butylbromide..20mg (Metamizole.....250mg 29. M/s Mass Hyopen Injection 022463 Reply not received. Pharma, Lahore Each 5ml contains:- Hyoscine N-Butyl BromideBP.....20mg Metamizole BP..1000mg 30. M/s K.P.L, Dypron Injection 020327 Reply not received. Karachi Each ml contains:- Metamizole.........500mg 31. -do- Hyoscine Compound Tablets 007858 Reply not received. 32. M/s Epoch Epospan Tablets 020612 Reply not received. Pharmaceuticals, Each tablet contains:- Karachi Hyoscine-N-Butyl bromide.............10mg Metamizole Sodium..250mg 33. -do- Dipyrol Tablets 020577 Reply not received. Each tablet contains:- Metamizole ……500mg 34. M/s Humayun Humapan Injection 020743 Reply not received. International, Each 5ml contains:- Faisalabad Hyoscine -N-Butyl Bromide................20mg Metamizole.........1000mg 35. -do- Dipyrex Injection 020744 Reply not received. Each ml contains:- Metamizole...........500mg 36. M/s Global Surfen Tablets 022362 Reply not received. Pharma, Each tablet contains:- Islamabad Hyoscine -N Butylbromide............10mg Metamizole.............250mg 37. M/s Macter Mizolin Injection (I.M/I.V) 021731 Reply not received. International, Each ml contains:- Karachi Metamizole Sodium..500mg 38. -do- Mizolin M Injection (I.M/I.V) 021732 Reply not received. Each ml contains:- Metamizole Magnesium.400mg 39. M/s PDH Labs, Pyrexil Injection 002466 Reply not received. Lahore Each ml contains:- Metamizole Sodium....500mg 40. M/s Alen Hyoscine Compound Tablets 004012 Reply not received. Pharmaceuticals, Each tablet contains:- Risalpur Hyoscine Butylbromide......10mg Metamizole.............250mg 41. M/s Swiss Pharma, Dipyron 500mg Tablets 027942 Reply not received. Karachi Each tablet contains:- Metamizole ……..500mg 42. M/s Regent Dipyron Tablets 030157 Reply not received. Labs., Karachi Each tablet contains:- Metamizole………..500mg 43. M/s Chas A. Anapyrol Injection 031266 Reply not received. Mendoza, Each 2ml contains:- Karachi Metamizole Magnesium…80mg 44. -do- Anapyrol Syrup 031267 Reply not received. Each 5ml contains:- Metamizole Magnesium…..50mg 45. -do- Anapyrol Tablets 031268 Reply not received. Each tablet contains:- Metamizole Mangesium……80mg 46. M/s Macquin‟s , Mauscopan Ampoules 039186 Reply not received. Karachi Each 5ml contains:- Hyoscine-N-Butylbromide..20mg Dipyron (Metamizole)….250mg 47. M/s Opal Labs, Analgin Tablets 000880 Reply not received. Karachi Each tablet contains:- Metamizole ……..500mg 48. -do- Analgin Drops 010576 Reply not received. Each ml contains:- Metamizole ……..500mg 49. M/s Bliss Blisspyron Syrup Reply not received. Pharma, Karachi Each ml contains:- Dipyron …..50mg 50. M/s Amros Dipyron Injection 019369 Reply not received. Pharma, Karachi 51. -do- Hyoscine Compound Injection 019381 Reply not received. 52. M/s Geofman Dipyron Injection 004966 Reply not received. Pharmaceuticals, Karachi 53. -do- Dipyron Tablets 002507 Reply not received. 54. -do- Geospasmocin Injection 002494 Reply not received. Each 5ml ampoule contains:- Hyoscine – N- Butylbromide …..20mg Metamizole ………250mg 55. -do- Geospasmocin Tablets 002495 Reply not received. Each tablet contains:- Hyoscine – N- Butylbromide …..10mg Metamizole ………250mg 56. M/s Saydon Dipyron Tablets 020004 Reply not received. Pharmaceuticals, Peshawar 57. M/s Semos Dipyron Tablets 014383 Reply not received. Pharma, Karachi 58. M/s Siza Dipyron Tablets Reply not received. International, Lahore 59. M/s Star Labs., Dipyron Tablets Reply not received. Lahore 60. M/s Dipyron Tablets 001776 Reply not received. UnexoLabs., Lahore 61. -do- Hyoscine Compound Tablets 007577 Reply not received. 62. M/s Elko Elkopyron Injection 012020 Reply not received. Organization, Each ml contains:- Karachi Dipyron ……….500mg 63. -do- Elkopyron Syrup 011575 Reply not received. Each ml contains:- Dipyron ……….50mg 64. M/s Pharmacare Fibrex Tablets 012372 Reply not received. Labs., Lahore Each tablet contains:- Metamizole …….500mg 65. M/s Irza Phama, Javalgin Injection 012696 Reply not received. Lahore Each 2ml contains:- Dipyron ……….1000mg 66. -do- Javalgin Tablets 007808 Reply not received. Each tablet contains:- Dipyron ……….500mg 67. -do- Hyoscine Compoud Tablets 008189 Reply not received. 68. Hyoscine Compound Injection 012692 Reply not received. 69. M/s Lisko Liskogin Tablets 010971 Reply not received. Pakistan, Each tablet contains:- Karachi Metamizole ……500mg 70. -do- Liskogin Syrup 003958 Reply not received. Each ml contains:- Metamizole ……50mg 71. M/s Krka-Pak, Metavine Tablets 012048 Reply not received. Karachi Each tablet contains:- Metamizole ………500mg 72. -do- Metavine Syrup 004021 Reply not received. Each 5ml contains:- Metamizole ………50mg 73. M/s Harman Hyoscine Compound Injection 017770 Reply not received. Pharma, Lahore 74. M/s Mediate Hyoscine Compound Tablets 011517 Reply not received. Pharmaceuticals, Each tablet contains:- Karachi Hyoscine – N- Butylbromide …..10mg Metamizole ……………..…250mg Decision: The Drug Registration Board examined the replies of the show cause notices submitted by pharmaceutical manufacturers. The representative of M/s. AGP. Syed Abid Mumtaz, Deputy Managing Director and Mr. Hamayun Regional Sale Manger appeared before the Board and extended their arguments in favour of non-withdrawal of Metamizole registrations. They were of the view that Metamizole adverse effects are limited to combinations forms and M/s. AGP (Pvt.) Ltd; has already been withdrawn its drugs which were in combination form i.e. “Spaslar Capsule & Syrup. They also submitted different reports indicating that “Agranulocytosis Attributable to Dipyrone was having geographical attitude with very minute appearance as indicated through different studies and are limited to 1% of the using population. On the query of Member Registration Board it was stated that the drug is not available in USA & UK. Similarly Dr. Aman Ullah Khan and Dr. Musharaf of M/s. Sanofi Aventis presented arguments in favour of non-withdrawal of the “Metamizole” preparation. They were also of the view that reported estimate of the risk of Agranulocytosis associated with “Metamizole” have widely varied. They stated that the risk was high only in Sweden. They also requested non- withdrawal of the registrations of “Metamizole” drugs. The Drug Registration Board after consideration and analysis replies to the show cause notice by the firms and presentations of M/s. AGP, Karachi and M/s. Sanofi Aventis, Karachi decided:- i. To cancel all the drug registrations with immediate effect in oral dosage forms containing “Metamizole” either alone or in combination form. ii. All the manufacturers shall withdraw the stocks of these drugs within 14 days from the market through their market forces and authorized agents, as prescribed in Rule 30 (10) (a) of Drugs (Licensing, Registering & Advertising) Rule 1976. . iii. Advertisements shall be published by all the concerned manufacturers in the national newspapers regarding the withdrawal of “Metamizole” drugs within a week and compliance report shall be submitted to this Ministry within fortnight period. iv. Provincial Governments shall supervise the withdrawal during the stipulated period and after the withdrawal period of 14 days start legal proceedings against those manufacturers, distributors and retailers involved in the manufacturing and selling of these drugs as provided under clause b of Sub- Section 12 of Section 7 of Drug Act, 1976, which states that Provincial Government shall take all such steps as may be necessary to prevent the manufacture or sale of a drug, the registration of which has been cancelled or stand suspended. The decision of cancellation of drug registration is based on the following grounds:- As stated in clause b & d of Sub-Subsection 11 of Section 7 of Drug Act, 1976, the circumstances in which drugs were registered no longer exist and sufficient evidence is available about the toxicity / adverse effects of these drugs either alone or in combination to cancel these drug registrations. M/s. Merck Marker Pakistan, Karachi has voluntarily withdrawn all their registered drugs containing “Metamizole”. The drug “Metamizole” was not available at the market of USA and UK either alone are combination form. According to World Health Organization pharmaceutical restrictions in ued and availability report prepared within the context of United Nation Publication in the up date of 6th issue March, 2001 report “Metamizole” was placed in the consolidated list of products whose consumption and / or sale have been banned, withdrawn, severely restricted or not approved by the governments:- “Metamizole was withdrawn from the market of the following countries as stated below:- S. No. Name of Country(s) Date of Withdrawal 1. Armenia February, 2000 2. Colombia June, 200 3. Maracoo May, 2000 4. Sweden 1999 5. Syria 1998 6. Yuman 1998 7. Zimbabwe 1998 8. Saudia Arabia 1999 ITEM NO.II-B PERSONAL HEARINGS UNETHICAL MARKETING PROMOTION M/s Bosch Pharmaceuticals, Karachi have complained that M/s Sanofi Aventis, Karachi is playing unethical marketing promotional activities. As in the product promotional material the firm is propagating that local companies are generally producing sub-standard drugs which often take longer time disintegration, dissolution, thus making no therapeutic effect and importing cheap raw material from India, Bangladesh and China to decrease the cost. This practice is the violation of Rule 31 (6) of Drugs (Licensing, Registering and Advertising) Rules, 1976 which clearly states that “no advertisement under this rule shall contain direct or indirect compare in any way with and other drugs or substances or remedy for any diseases for the purpose of attracting customers or with a view to discredit other such products. This is also violation of Schedule 4 of these rules. The representative of M/s Sanofi Aventis, Karachi have been called for personal hearing to explain their position before the Drugs Registration Board. Decision:- Dr. Musharaf and Dr. Aman Ullah of M/s. Sanofi Avenits, Karachi appeared before the Registration Board and defended their way off advertisement through “Portraying” The Daily Dawn news repot on the promotion material for the information of prescribers. The Daily Dawn newspaper report pasted on promotion material contained that:- i. Local Pharmaceutical companies are generally proceedings substandard drugs, which often take longer time in disintergradations, dissolution and thus making no therapeutic efficacy. ii. Generally local companies imported cheap raw materials from India, Bangladesh and China to lessen the cost. iii. Products are below standards and hence not effective for therapeutic use. The most probable cause of poor quality of drug is absence of adequate quality assurance during manufactures. iv. Substandard drugs source in pharmacy of less developed countries could contribute to global microbial resistance and the therapeutic failure of infections diseases. The Chairman and the members of the Board took serious notice of this unethical way promotion and malpractice and decided:- 1. Marketing manager of M/s. Sanofi Aventis Pakistan, Karachi ho is responsible for the violation of Rule 31 (6) of Drugs (Licensing, Registering & Advertising) Rules, 1976, shall submit unconditional apology to the M/o. Health with the undertaking to refrain the same in future. 2. Marketing Manager of M/s. Sanofi Avenits, Karachi who is responsible for the violation of Rule 31 (6) of Drugs (Licensing, Registering & Advertising) Rules, 1976, shall publish unconditional apology in one English and one Urdu newspaper having country wise circulation with the denial that all the above mentioned four allegations made part of promotional material of M/s. Sanofi Aventis, Karachi are based less and this will not be repeated in future. 3. Compliance to this decision shall be submitted by the firm within 15 days along with the copies of press clippings published. In case of failure to comply with the decision the matter will be placed in the next meeting of the Board for reconsideration. ITEM NO. III. MISCELLANEOUS CASES AVAILABILITY OF ORAL PILLS AS OVER THE COUNTER PRODUCT. M/s. Greenstar Social Marketing has raised the issue regarding sale of oral pills and submit their observation as under:- Oral pill is classified as a medicine and officially it is available from a licensed chemist with prescription. This restricts its availability, though efforts to encourage voluntary practice of birth spacing warrant its easy access at convenient locations, which includes the general stores. The convenient availability is particularly problematic in small towns and far flung rural, where majority of our population reside. The effect of all fertility moderation efforts largely depends on increase level of acceptance and continued practice by this major group of the target population. The Social marketing organizations are only allowed to train doctors, LHVs and chemists. They are not allowed to train shopkeepers or even paramedics, who may be selling the pills, or whose customers may want them to dispense the product. Similarly, manufacturers of pill such as M/s. Zafa are not allowed to visit these shops for training and promotional activities. These barriers to access need to be considered and addressed to meet the unmet need of family planning in particular. Greenstar has taken up the matter with M/s. Health and reiterated the point of marking pill available as over the counter product. The rationale was explained and practices being followed in the neighboring countries cited. In India, pill was reclassified and included in Schedule H, as an over the counter product. Bangladesh has piloted a scheme with 500 successful and helping to promote was availability of pill. Similar initiatives have been taken in countries such as Indonesia, the Philippines and Sri Lanka. Pakistan needs to consider moving in this direction as well, particularly when they are striving for raising the CPR in the pursuit of population stabilization goal. The issue apparently requires a review of the Drug Act and the Rules in order to accommodate the desired provision. The Drug Contoller may kindly undertake the review for initiating appropriate action. It is submitted that as per SRO 497 (I)/2001 dated 26th June, 2001 the oral contraceptives are sale on the following conditions:- i. The contraceptive is stored, and distributed by a Lady Health Visitor or a Health Care Personnel under the authority of an organization duly registered with the M/o. of Population Welfare and not for any commercial purpose. ii. The contraceptive is stored, and distributed for a Population Welfare Programme duly approved, by the M/o. Population Welfare and not for any commercial purpose. iii. The price charged for the contraceptive, by the Lady Health Visitor or Health Care Personnel shall not be more than the approved maximum retail price. Decision:- The request of M/s. Social Marketing was deferred for expert opinion from the gynecologists about the side effects / misuses of contraceptives if allowed. INSPECTION COMMITTEE The Central Licensing & Registration Board formulated a committee of following members for the finalization of format of check list / Inspection Performa regarding the visits / inspections of pharmaceutical units- 1. Abdul Latif Shiekh Chairman (Member CL &RB) 2. ZafarMooraj Representative, Pharma Bureau 3. Dr. M.H Siddiqi Representative, PPMA 4. Mr. Fakhurddin Aamir Secretary (FID, Karachi) This committee will finalize their recommendations within 20 days to the Secretary Central Licensing & Registration Board which will be circulated to all the members of Board for their comments and finally submitted for approval by the Registration Board. AMENDMENT COMMITTEE A committee of following members was constituted:- 1. Dr. Jamshad Chairman (Member CL&RB) 2. Mr. Atta-ur-Rehman Member, (Chief Drug Inspector, Balochistan) 3. Mr. Abdul Sattar Sohrani Secretary (Deputy Drugs Controller (Reg-II), Islamabad 4. Dr. Sheikh Akhtar Hussain FID, Lahore This committee will finalize recommendations for amendments in the rules in accordance with the needs in the current scenario / policies approved by the Central Licensing & Registration Board. Main focus of this committee will be import policy. RATIONALIZATION OF PRICES. Decision:- During the discussion of shortage of drugs Mr. Zafar Mooraj Observer on the Board complained about the low prices of certain drugs. The Chairman Registration Board after through discussion again reiterated that the M/o. Health is in favour of rationalization of prices. The prices of drugs which are very low should be increased and the prices of those drugs which are very high should be decreased. It was also decided that disparity of prices of multinational and local pharmaceutical firms shall be minimized Dr. Haroon Saddiqi observer of PPMA supported the decision. The Chairman Registration Board requested the PPMA and Pharma Bureau to come up with the proposals and mechanism to rationalize the prices of drugs which shall be made available to this Ministry within 20 days for discussion in the next Board meeting. 0 SHORTAGE OF ORPHAN DRUGS / NON-AVAILABILITY OF REGISTERED DRUGS Decision:- The matter of shortage of registered drugs was again taken up in the Registration Board and it was decided to produce data base about the manufacturing of registered drugs and their availability following measures shall be adopted:- i. As prescribed in Rule 30 (6) of Drugs (Licensing, Registering & Advertising) Rule, 1976 a record of quarterly production and disposal of drug shall be maintained and supplied to the Chairman Registration Board in Form-7 in months of January, April, July and October each year. ii. The FID / field officer of Drug Control Administration shall prepare the list of registered drugs during the inspection of each manufacturer indicating those being manufactured and those not being manufactured during the last 6 months. This report shall be included with the inspections and enclosed with the inspection reports to the Secretary Drug Registration Board. ESTABLISHMENT OF QUALITY CONTROL REFERENCE LABORATORY / BIO EQUILANCE CENTER Decision:- Chairman Registration Board reiterated during the discussion that a state of the art quality control laboratory may be established equipped with all the requisite facilities and equipments along with a bio equilance center in private public partnership with autonomous status. He requested the Pharma Bureau and PPMA representatives to put feasibility and plan as soon as possible because it is need of the hour. He also added a bio equilance center shall also be included in the project to facilitate the local pharmaceuticals industry as well as M/o. Health to ascertain certain the level of quality efficacy different pharmaceutical groups. PATIENT INFORMATION SHEET FOR CELECOXIB Decision:- The matter of Celecoxib‟s increase risk of serious cardiovascular events such as heart attack or stroke was considered in the meeting of Drug Registration Board. The Drug Registration Board approved the recommendations of FDA regarding the “Celecoxib”. It was decided that package insert of the drug shall be revised to include a serious warning to highlight the potential increased risk of cardiovascular events and well none risk of potentially life threatening stamen diseases. The approved and revised text of “Celecoxib” patient information sheet by the FDA was duly approved by the Drug Registration Board and it was decided that all the manufacturing firms already having market authorization of this drug shall add this information in the leaflets / package insert for the information of prescribers as well as patients. The compliance shall be submitted within a week time. U.S. FDA “Celecoxib” patient information is enclosed at (annex-A). ANALYSIS OF VARIOUS BRANDS OF OFLOXACIN BY THE CONSUMER PROTECTION NETWORK. Decision: Consumer protection network conducted a study about the analysis of various brands of “Ofloxacin” and concluded that most of the brands are of substandard quality including Tarivid Infusion of M/s. Aventis. This study came under the discussion of Central Licensing & Registration Board and it was concluded that the procedures for test / analysis of “Ofloxacin” adopted by the consumer protection network are defective and incredible. The effort made by the consumer protection network although may be with good intent but it is beyond the mandate and jurisdiction. It was decided that displeasure shall be conveyed to the consumer protection network.
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