Docstoc

MINUTES OF 196TJ MEETING OF DRUG REGISTRATION BOARD

Document Sample
MINUTES OF 196TJ MEETING OF DRUG REGISTRATION BOARD Powered By Docstoc
					MINUTES OF 196TJ MEETING OF DRUG REGISTRATION BOARD
HELD ON 22ND – 23RD FEBRUARY, 2006. (REG-II-SOUTH)

The 196th meeting of the Drug Registration Board was held on 22nd – 23rd February, 2006 in the Committee Room of the National Institute 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. 2. 3.

Maj. Gen. ® MI Burney HI (M), SI National Institute of Health, Islamabad Maj. Gen ® Nasir-ul-Islam Rawalpindi. Brig. Muzammil Hassan Najmi, Professor of Pharmacology and Head of Department, Army Medical College, Rawalpindi. Lt. Col. Aslam Khan Pulmanologist, Army Medical College, Rawalpindi Prof. Shahnawaz, Professor of Pharmacology and Head of the Department, Ayub Medical College, Abbottabad. Mr. Abdul Latif Sheikh, Director Pharmacy, Nutrition & CSSD Services, Agha Khan University Hospital, Karachi Dr. I.U Beg, Associate Surgeon, Federal Government Services Hospital, Islamabad Dr. Ijaz Ahmed, Associate Professor, University of Veterinary and Animal Sciences, Lahore. Prof. Dr. Muhammad Jamshaid, Principal, University College of Pharmacy, University of the Punjab, Lahore. Assistant Animal Husbandry Commissioner M/o. Food, Agriculture & Livestock, Islamabad

4.

5.

6.`

7.

8.

9.

10.

44987412-613b-4366-821b-7a2f464b0dbe.doc

1

11.

Mr. Muhammad Saad Qureshi, Deputy Secretary, M/o. Law Justice & Human Rights, Islamabad Controller of Patents, Government of Pakistan, Karachi Representative M/o. Industries & Production, Islamabad Representative M/o. Commerce, Islamabad Cost Accountant, M/o. Health, Islamabad. Dr. Farnaz Malik, Drugs Controller, Ministry of Health, Islamabad. (Also Secretary of the Board)

12.

13.

14.

15.

17.

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, Haji Muhammad Hanif Blue, 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 195th (A) of Me-Too Committee Held on 4th January, 2006.

Decision:

The minutes of the 195th meeting were circulated to all the members and were confirmed because no

observation was received from any member. Moreover, the Drug Registration Board granted approval of the minutes of 195th-A Committee meeting.

44987412-613b-4366-821b-7a2f464b0dbe.doc

2

ITEM NO. II Galenical Products: Galenaicals products of various firms were rejected by the Drugs Registration in its 193rd and 194th meetings held on 7th – 8th September, 2005 & 31st October, 2005 on the following grounds:1. Do not bear any therapeutic indications / use. 2. Bear misuse potential as intoxicant liquor. 3. Concentrations of Alcohol in the formulations is not clinically recommended and are not safe. 4. Better alternatives with established safety and efficacy as compared to this drugs are available in the market.

5. All the expert members of the Board unanimously decided that this formulation is not required in the best public interest. Following firms submitted extra constitutional petition in a double bunch of Sindh High Court, Karachi. i. ii. iii. iv. M/s. Medicure Laboratories, Karachi. M/s. Gaba Laboratories, Karachi. Karachi Pharmaceutical Laboratories, Karachi. Regent Laboratories, Karachi.

The case was fixed on 7th February, 2006 in the Sindh High Court, Karachi and after arguments of honorable court directed the petitioners shall be provided an opportunity of personal hearing in the Drugs Registration Board and case shall be decided within one month. Following products of these firms are submitted for consideration of the Board:-

44987412-613b-4366-821b-7a2f464b0dbe.doc

3

S. No.

Name of Manufacturer M/s.Medicure Labs Karachi.

Name of Drugs with Composition Tincture Ipecauanha Contains:Ipecauanah Liuid Extract……100ml Dilute Acetic Acid…16.5ml Ethanol………210.0ml Glycerol………..200.0ml Purified Water sufficient To produce…….1000.0ml (Glenical) Spirit Amonia Aeromatic Contains:Ammonia BiCarbonate..25.0gm Ethanol……..750.0ml Strong Ammonia Solu…67.5ml Lemon Oil……….5.0ml Nutmeg Oil………3.0ml Purified Water……..1000.0ml (Carminative) Tincture Belladonae Contains:Belladonae Herb………100gm Ethanol ……….64 to 69% V/V Content of Alkaloids..0.028 to 0.3%…Glenicals) Aqua Menthapip Conc. Contains:Peppermint Oil…..20ml Alcohol…………600ml Distilled Water…….1000ml (Glenicals) Tincture Scillae Contains:Scillae Bruised………100gm Ethanol Content…….1000ml (Glenicals) Peppermint Spirit Contains:Peppermint Oil…..100ml Ethanol 90% V/V…..1000ml (Glenicals) 4

Pack size

Demanded Price I66.00 I74.00

1.

400ml 450nml

2.

-do-

400ml 450ml

I35.00 I41.00

3.

-do-

400ml 450ml

I35.00 I41.00

4.

-do-

400ml 450ml

I35.00 I41.00

5.

-do-

400ml 450ml

I35.00 I41.00

6.

-do-

400ml 450ml

I42.00 I48.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

7.

-do-

Tincture Zingiberis Mitis Contains:Strong Ginger Tincture…200ml Ethanol…………..1000ml (Glenicals) Aurantil Syrup Contains:Orange Tincture…………..60ml Suagr………………..667gm Sodium Benzoate…….2.5gm Methyl Paraben………2.5gm Phenyl Paraben….0.25gm Orange Colour…..0.75gm Spirit Chloroform…..20ml Purified Water to…1000ml (Glenicals) Tincture Gentian Co. Contains:Gential………100gm Dried Bitter Orange Peel..37.5gm Cardammon seed.12.5gm Distilled water sufficient to produce……….1000ml (Glenicals) Liquor Amonia Acetate Fort Solution. Contains:Ammonia BiCarbonate…..470gm Glycial Acetic Acid…454gm Stron Ammobnia……100ml Purified Water to produce.1000ml (Glenicals) Extract Glycerrizhae Liq. Contains:Mulethi…………..100gm Chloroform……….100ml Water…………….750ml Alcohol 90% (V/V)..250ml Extract Glycerrizhae…..500gm (Glenicals)

400ml 450ml

I61.00 I69.00

8.

-do-

300gm

I18.00

9.

-do-

400ml 450ml

I35.00 I41.00

10.

-do-

400ml 450ml

I40.00 I46.00

11.

-do-

400ml 450ml

I35.00 I41.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

5

12.

-do-

Tolu Syrup Contains:Balsum of Tolu……..25.0gm Suage…………….667.0gm Sodium Benzoate……..2.5gm Methyl Paraben…0.5gm Propyl Paraben…0.25gm Spirit Chloroform….20ml Purified Water to ontain.000ml Tincture Camphor Co. Contains:Opium Tincture……50ml Benzoic Acid…………..5gm Camphor……………….3gm Anise Oil………………..3ml Ethamol……………1000ml (Analgesic) Aqua Chloroform Conc. Contains:Chloroform………….100ml Alcohol………………600ml Distilled Water……..1000ml (Galenical) Tincture Hyoscyamus Contains:Liquid Extract of Hyoscyamus……100ml Ethanol……….1000ml (Anti Spasmodic) Tincture Opii Contains:Opium Sliced………..200mg Etanol……….90% V/V (Glenical) Tincture Cardanninu Co. Contains:Cardammomi Oil0.450ml Caraway Oil……0.400ml Ochinical inn coarse powder………..7.0gm Glycerol…….50.0ml Ethanol………1000ml (Galenical)

300gm

I18.00

13.

-do-

400ml 450ml

I53.00 I60.00

14.

-do-

400ml 450ml

I31.00 I35.00

15.

-do-

400ml 450ml

I31.00 I35.00

16.

-do-

400ml 450ml

I180.00 I230.00

17.

-do-

400ml 450ml

I35.00 I41.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

6

18.

-do-

Spirit Aetheris Nitrosi Contains:Ethanol….90% v/v. Tincture Zingiberis Fort Ginger Corrse Powder…….500gm Ethanol…………1000ml (Galenical) Tincture Senega Each 1000ml contains:Senega Liquid Extract..200ml Alcohol 60%….1000ml (galenical) Tinctrue Hyoscyamus Each 1000ml contains:Hyoscyamus liquid extract..100ml Alcohol 70% Q.S .to1000ml (Galenical) Tincture Ferri Perchlor Each 1000ml contains:Ferric Chloride 60%..250ml Alcohol. 90%……..250ml (Galenical) Tincture Ipecac Each 1000ml contains:Ipecacuanha Liq. Extract..100ml Dilute Acetic Acid…16.5ml Alcohol 90%…….210ml Glycerin…………200ml (Galenical) Aqua Mentha Pip Conc. Each 1000ml contains:Peppermint Oil…..20ml Alcohol 90%…….600ml (Galenical) Tincture Belladonna Each 100ml contains:Belladonna herb….100gm Alcohol 70%……….1000ml (Galenical)

400ml 450ml

I46.00 I53.00

19.

-do-

400ml 450ml

I155.00 I173.00

20.

M/s.Karachi Pharmaceutical Labs Karachi.

450ml

21.

-do-

450ml

22.

-do-

450ml

23.

-do-

450ml

24.

-do-

450ml

25.

-do-

450ml

44987412-613b-4366-821b-7a2f464b0dbe.doc

7

26.

-do-

Tincture Gentian Co. Each 1000ml contains:Gentian…………..100.0gm Cardamon seed……12.5gm Dried Bitter-Orange Peeal..37.5gm Alcohol 45%……1000ml (Galenical) Tincture Aconite Each 1000ml contains:Aconite in ontains y fine Powder………….150mg Alcohol 70%……1000ml (Galenical) Tincture Scillae Each 1000ml contains:Squill bruished ……100gm Alcohol 60%……….1000ml (Galenical) Tincture Cardamon Co Each 1000ml contains:Cardamon seed incoarse Powder……….14gm Caraway seed in coarse Powder………..14gm Cinnamon bark in coarse Powder………..28gm Glycerin……….50ml Alcohol 60%…….1000ml (Galenical) Spirit Aether Nitrous Each 100ml contains:Ethyl nitrite………2% W/V (Galenical) Tincture Myrrh Each 1000ml contains:Myrrh crushed ……200gm Alcohol 90%…..1000ml (Galenical)

450ml

27.

-do-

450ml

28.

-do-

450ml

29.

-do-

450ml

30.

-do-

450ml

31.

-do-

450ml

44987412-613b-4366-821b-7a2f464b0dbe.doc

8

32.

-do-

Extract Glycyrrhizae Liq. Each 1000ml contains:Liquorice in coarse powder…………1000gm Alcohol 90%……..25ml Chloroform water Q.S.ti.1000ml (Galenical) Spirit Ammonia Aromatic Liq Each 1000ml contains:Ammonium Bicarbonate..25.0gm Ammonia solution 30%..67.5ml Nutmeg oil……3.0ml Lemon oil……..5.0ml Alcohol 90%…….750.0ml (Galenical) Tincture Camphor Co Liq. Each 1000ml contains:Opium tincture…….50ml Benzoic acid…….5gm Anise oil………..3ml Alcohol 60%……1000ml (Galenical) Tincture Belladonna Liq. Each ml contains:Belladonna Herb,in Modetately Coarse powder….100gm Alcohol …………70% Hyoscyamine..0.28 to 0.032) (Carminative) Aqua Menthae Piperitae Concentrata Liq. Each ml contains:Pepermint Oil………….20ml Alcohol 90%…………600ml Purfied Water……….1000ml (Carminative) Ext Glycyrrhiza Liquid. Each ml contains:Liquorice, Unpeeled……..1000gm Chloroform water..Sufficent Qty Alcohol 90% Sufficent Qty (Carminative) 9

450ml

33.

-do-

450ml

34.

-do-

450ml

35.

M/s. Regent Labs, Karachi

450ml

36.

-do-

450ml

37.

-do-

450ml

44987412-613b-4366-821b-7a2f464b0dbe.doc

38.

-do-

Spirit Ammonia Aromatic Liquid. Each ml contains:Nutmeg Oil…….3ml Lemon Oil………5ml Ethanol 90%…….750ml Ammonium Bicarbodate…25gm Strong Ammonia Sol…67.5ml Puried Water……….1000ml (Carminative) Tincture Card Co. Liquid. Each ml contains:Cardamom Oil…….0.450ml Caraway Oil………0.400ml Cinnamon Oil………0.225ml Coarse powder……….7gm Glycerol…………..50ml Ethanol 60%……….1000ml (Carminative) Tincture Scillae Liquid. Each ml contains:Squill, Bruised…….100gm Alcohol 60%………..1000ml (Carminative) Tincture Myrrh Liquid Contains:Myrrh Crushed…200.00gm Alcohol 90% to.1000.00ml (Galenical) Aqua Anisi Liquid Contains:Anise Oil……..20.00gm Alcohol 90%…..700.00ml (Carminative) Tincture Card Co.Liquid Contains:Cardamom Seed…..14.00gm Caraway………14.00 gm Cinnamon……….28.00gm Cochineal………….7.00gm Glycerin…………..50.00ml Alcohol 60%……..1000.00ml (Carminative)

450ml

39.

-do-

450ml

40.

-do-

450ml

41.

M/s. Gaba Pharma, Labs, Karachi.

450ml

42.

-do-

450ml

43.

-do-

450ml

44987412-613b-4366-821b-7a2f464b0dbe.doc

10

44.

-do-

Tincture Extrac Glycyrrhiza Contains:Liquorice Powder….1000.00gm Chloroform water of sufficient Alcohol…90%) (Expectorant Flavour) Tincture Gentian Compound Contains:Gentian…….100.00gm Dried Blister Orange peel..37.5gm Cardamom seed….12.5gm Alcohol 45% to…1000.00ml (Galenical) Tincture Spirit Ammonia Aromatic Liq. Contains:Ammonia Bicarbonate…25.00gm Nutmeg oil……….3.00ml Strong Ammonia Solu…..67.5ml Lemon Oil…………….5.00ml Alcohol 90%…..750.00ml Purified Water …..1000.00ml (Carminative) Aqua Menthapip Conc.Liq. Contains:Peppermint Oil…20.00ml Alcohol 90%…..600.00ml Purified water to make..1000ml (Carnubatuve) Tincture Zingiberis Mitis Liq. Contains:Strong Ginger Tinc…200.00ml Alcohol 90% …1000.00ml (Carminative) Spirit Chloroform Liq. Contains:Chloroform……..50.00ml Alcohol 90%….1000.00ml (Carminative)

450ml

45.

-do-

450ml

46.

-do-

450ml

47.

-do-

450ml

48.

-do-

450ml

49.

-do-

450ml

44987412-613b-4366-821b-7a2f464b0dbe.doc

11

Decision: The representative of the firms were called for personal hearing on 23rd February, 2005 on the direction of honorable Sindh High Court, Division Bench, Karachi for reconsideration of rejected applications of Galenicals products and they were asked to come with clinical justification / supportive data in their defence keeping in view the reasons of rejection conveyed to them through rejection letters by the Ministry of Health. Mr. Abid Hameed Puri, Advocate appeared on behalf of following firms:1. 2. 3. 4. M/s. Medicure Labs, Karachi M/s. Regent Labs, Karachi M/s. K.P.L. Karachi. M/s. Gaba Pharma, Karachi

He also submitted wakalet nama duly signed by the said firms along with a written reply and as the firms were asked to bring clinical justification and supportive data regarding the registration of Galinicals keeping in view the reasons of rejection already conveyed to them through rejection letters dated 12th November, 2005;1. Do not bear any therapeutic indications / use. 2. Bear misuse potential as intoxicant liquor. 3. Concentrations of Alcohol in the formulations is not clinically recommended and are not safe. 4. Better alternatives with established safety and efficacy as compared to this drugs are available in the market. 5. All the expert members of the Board unanimously decided that this formulation is not required in the best public interest. “The counsel submitted written reply the grounds of rejection are completely whimsical, arbitrary and indicate a complete lack of application of mind to the available facts and data on the file, the previous history and the present status vis-avis, the pharmacopeial information etc, it was also stated as the requirement of justice demand that a party called jupon to suffer consequences of any propose action should be provided with relevant particular and documents to controvert and rebut the allegation and the proposed action. We hereby request mentioned at provided with specific information and documents vis-avis the reasons mentioned at S. No. 4 & 5 of the grounds of rejection, namely, as to what better alternatives with established safety and efficacy as compared to these drugs are available in the market. And, to be provided with the opinions / decisions of the expert members of the Board on the basis whereof it has been decided that the formulation is not required in the best public interest and onus of information of clinical justification and
44987412-613b-4366-821b-7a2f464b0dbe.doc

12

supportive data for the rejection lies on the Ministry of Health. They reserve their rights to submit their view point and explanation to refute and impugn such grounds in writing upon receiving the requisite information and details.That with regards the first three grounds we submit as follows:Regarding ground No. 1, namely, that these products do not bear any therapeutic indication / use, they invite reference to the fact that the Central licensing Board under its letter bearing No. F. 7-4A/76-QC (Lic), dated 26th June, 1978, and subsequent letters bearing No. F. 9-17/92-Lic (M-103) dated 17/08/1993, 16/11/1993, 29/02/1993, and 16/01/1994 etc., had been specifically approving the manufacture of these Galenicals.

That thereafter, under SRO No. 877 (1)/2000, dated 9/12/2000as communicated under letter No. F. 9-5/2000 (LIC), dated 11th January, 2001, by the Deputy Drugs Controller, Galenical items were required to be registered like other formulation drugs, and applications along with requisite fee of Rs. 8000/- for registration were to be made within 30 days, and if no such applications were received, the approvals granted earlier would be deemed to have been terminated.

Accordingly, in the context, on the one hand a consistent policy was pursued by the Ministry of Health for the continued manufacture of Galenicals, and in fact, they were deemed worthy of being registered like other formulation drugs, which exfacie established that these products had and have therapeutic use / utility, and on the other hand, such letter dated 11/01/2001, conveys the conveys the continuity of permission for manufacturing of Galenicals, subject to making the application for registration within 30 days.

That in the comments submitted under your signature in Writ Petition No. D-1227/2005, at annexure-B, a list of 15 Galenical items approved by the Central Licensing Board is filed and annexure-D, with such comments shows Tinctures and spirits which are subject of an individual monograph in the British Pharmacopoeia. That the British Pharmacopoeia, United States Pharmacopoeia and the British Pharmacopeutical codex, till date, in addition to the Indian Pharmacopoeia, carry these Tinctures, extracts, etc., in their monographs and also declare their actions and uses in the various and different physical conditions.

In view of such position, the Ministry of Health is stopped from questioning in any manner the therapeutic indications / uses of these Galenicals, and indeed the burden of establishing, proving that these Galenicals do not bear any therapeutic use, in the light of conduct and admission made by the Ministry and the overwhelming international literature available, would be on the body or person asserting to the contrary.
44987412-613b-4366-821b-7a2f464b0dbe.doc

13

Accordingly, you may provide us with any plausible or cogent basis to dispute the therapeutic use and indications of these items.

With regards ground No. 2, namely, that these items bear misuse potential as intoxicants / liquor, it is respectfully submitted that the alcohol used in these products is as a solvent to extract the ingredients, and is in accordance with the procedure provided under the various pharmacopoeias.

That as may be known, Galenical pertains to the ancient system of medicine taught and practiced by Galenus or Galen; and Galenicals are medicines prepared according to the formulas of Galen, which term is now used to denote standard preparations containing one of several organic ingredients, as contrasted with pure chemical substances.

There can be no misuse of the actual Galenical products as Intoxicants / liquor and such misuse can only occur, if any unscrupulous manufacturer sells off the permitted alcohol acquired by him, without putting it to use in the preparation of the product, for which purpose the Excise officials maintain a record and inventory and which in ordinary course may not be possible if persons act in good faith.

Regarding ground No. 2, namely, that concentration of alcohol in the formulation are not clinically recommended and are not safe, it is submitted that the same is a totally baseless, illogical and imaginary ground as the concentrations are as per prescribed formulation given in the various pharmacopoeias, and are not dependent on the whims and fancies of any individual manufacturer.

That in any event, in the counter-affidavit filed by Mr. Ahmed Din Ansari, Federal Inspector of Drugs, Karachi, in Writ Petition No. D-1227/2005, in para 6A, he has declared Tincture Benzoin Co, surgical spirit, Tincture Iodine, and Tincture Kenocort as Galenical drugs which could not be misused, whereas alcohol content in these drugs ranges from 90-95% and establishes that the statement in such ground has not been bonafidely made. That as the manufacture of Galenical items had continued throughout, and in 2001, applications for registration were sought, these grounds, if at all, would have been available or applicable, had there been a change in the circumstances since 2001, which may have caused new grounds to reconsider the propriety of manufacture and use of Galenicals, based whereon these grounds for refusing registration could have been raised.
44987412-613b-4366-821b-7a2f464b0dbe.doc

14

As the same circumstances have existed throughout, these grounds have no merit whatsoever, and in addition to the principle of estoppel being applicable to the raising of these grounds to refuse registration, the same would also be hit by the principles of locus-poenetentiae as the government had called upon and acted on the basis of the drugs being worthy of registration and on the basis of the government action, the answering respondents had submitted their application for registration. The Ministry thus cannot retract in the present mater unless is drastic change in the circumstances.

That the action being nearly 5 years after the submission of registration applications, reeks of malafides and bias, and is contrary to the consistent policy, practice and procedure adopted in such matters, and is thus bad at law.

It may be added that internationally there is a clear move towards organic and natural substances being used whether in foodstuff etc., and in such circumstances Galenicals being extracted from natural herbs deserve to be supported vis-à-vis synthetic elements which have a much higher and substantial risk of harmful side effects and reactions.

There must be due emphasis on indigenous production so that through research the traditional indigenous system of treatment may advance and develop.

In the above stated facts and circumstances, whilst they again request to be provided the particulars and details regarding the grounds raised at S. Nos. 4 and 5, based on the available literature, data and practice, there is no merit, justification or rationale for either refusing registration or questioning of status of Galenicals as substantive medical preparations. The reply submitted by the honorable counsel on behalf of applicants was not supported with any clinical justification or any supportive data regarding the safety efficacy and other parameters which are mandatory to be furnished by the person applying for registration as required under Section 7 (7)of Drugs Act, 1976 which clearly states that “A person applying for the registration of a drug shall furnish such information in respect of the drug as may be prescribed, including information relating to its efficacy safety and quality, or as may be required by the Registration Board for the purpose of evaluation of drug”.

44987412-613b-4366-821b-7a2f464b0dbe.doc

15

The counsel was asked that the pharmacopia gives only specifications of the drugs enlisted in it which deal with the testing method, limits for approval and analysis of drugs. For example rectified alcohol (96%) and heroin (Diacetylmorphine) both are monograph in pharmacopias and it does not gives right of registration to the applicants in this form nor alcohol is registered any where in the World as drug. The clinical data regarding the safety and efficacy is provided by the applicants which consists of the following parameters and was asked to reply the following queries:1. After clinical trials evidence in the form of data it is proved that the drug is safe for use in the given doses. That the drug applied for registration is effective against such and such diseases along with evidence of clinical trials and / or scientific justification through publication in the well known research journals or standard reference book of pharmacology, medicine and pharmacy. Assessment of dose through clinical trials that the drug is effective in such doses and schedule of doses as well as period of treatment of disease is also proved with data. Prescribing information like indications, contraindications, side effects and precautions are also given for applied drug which are to be evaluated by the Drugs Registration Board experts for approval. Alternative medicines which are available in the market are safe and effective as compared to the these products containing vegetables extracts used for symptomatic treatment. The maximum alcoholic contents clinically permissible for oral use is below 20% because the alcohol itself have pharmacological properties in addition to its solvent property. While the maximum alcoholic contents permissible under the excise act is 45% in various beverages. While on the other hand all the above applied formulations contain alcoholic content above the permissible limits of 45% and in a number of cases above 80%. The alcoholic content is abused as intoxicant liquor instead of treatment. The other ingredients, which are added in these drugs to develop the finished products, were not imported by these manufacturers during the last one year and quota of alcohol was claimed as admitted by the applicants in the petition, which is sufficient to believe that alcohol is misused and actual products are not produced.

2.

3.

4.

5.

6.

7. 8.

The counsel failed to reply these queries and satisfied the Drugs Registration Board. Moreover, Mr. Hanif Billo and Mr. Baber Mahmood, representing PCDA & PPMA respectively as observers also stated that Galenicals are misused as liquor intoxicants by the drinkers and are popular as kuppies in the market instead of there use for the purpose of treatment. The Board also informed the counsel that those Galenicals
44987412-613b-4366-821b-7a2f464b0dbe.doc

16

which are safe and effective and are meant for external use to be applied on the skin are being registered. For example Tincture, Iodine, Tincture Benzoin. Co and Surgical spirit. These could not also be taken as intoxicant liquor due to contents of the formulations. The honorable counsel requested some time instead of rejection of applications. The Drugs Registration Board after listening the arguments of the counsel and statements of observers unanimously rejected these applications of four firms under the Rule 29 (9) of Drugs (Licensing, Registering & Advertising) Rules, 1976 on the above mentioned grounds.

ITEM NO. III

VITAMIN POLICY Drugs Appellate Board has directed in its 124th sitting held on 10th November, 2005 that the Drugs Registration Board should formulate comprehensive policy for the vitamins & minerals. It was also said that in some of the countries they are being regulated and in other countries these are being treated as food supplements.

As far as vitamins and minerals are concerned it is submitted that it is strongly objected that there is misuse and overuse of vitamins & minerals and most of the products registered are irrational and there is wastage of money of poor people. These drugs are having lack of evidence of effectiveness and in appropriate effects are in appropriate combinations and doses. 1. In this regard BNF 49 March, 2005 edition states that vitamins are used for prevention and treatment of specific deficiencies states are where diet is to be inadequate. But not as dietary supplements there use as general “pick me ups” is of unproven value and in case of preparations containing vitamins A or D may be harmful if patient takes more than the prescribed dose. The fad for megavitamins therapy with water-soluble vitamins such as ascorbic acid and pyridoxine is unscientific and can be harmful. Bangladesh banned certain vitamin preparations on the grounds that this wastage of money of people and these are irrational stating following guidelines:-

2.

a) Vitamins should be prepared as single ingredients except B-complex. b) Vitamins will not be allowed to be combined with any other ingredient such as minerals and glycerophosphate etc. c) It will be allowed that vitamins shall be produced only in tablets capsules and injectable forms.
44987412-613b-4366-821b-7a2f464b0dbe.doc

17

d) No liquid will be permitted because of wastage of financial resources and tremendous misuse involved. e) However, pediatric liquid of vitamins will be allowed to be manufactured in 15ml bottles only. f) Combination of vitamins with analgesic or antibiotics will not be allowed except combination of pyridoxine with INH. g) Vitamins & antacid preparations will be manufactured only by local pharmaceutical firms. 3. India in October, 1999 banned the fixed dose combinations of Vitamin B1, B6 & B12 for human use with effect from January, 2001. They also Notified standards for formulations containing vitamins that patent are proprietary medicines containing vitamins for prophylactic, therapeutic or pediatric use shall contain vitamins in the vitamins in the quantities not less than and not more than specified below in single or in two divided doses daily.

44987412-613b-4366-821b-7a2f464b0dbe.doc

18

Vitamin

Unit

Patent or Properitary medicines containing vitamins for prophylactic use

Patent or proprietary medinces containg vitamins for therapeutic use

Patent or proprietary medinces containing vitamins for paediatric use

In Single dose or in two divided doses) per daily dose For adults For infants less than one year 5 Not less than 750 and not more than 3,000 Not less than 200 and not more than 400 Not less than 0.5 and not more than 1 Not less than 0.5 and not more than 1.5 Not less than 0.5 and not more than 1.5 Not less than 5 and not more than 15 Not less than 1 and not more than 3 For children abaove one year up to adults 6 Not less than 1,500 and not more than 5,000 Not less than 100 and not more than 400 Not less than 1 and not more than 4.5 Not less than 1 and not more than 5 Not less than 1 and not more than 3 Not less than 10 and not more than 40 Not less than 2.5 and not more than 10

1 Vitamin A

2 I.U.

3 Not less than 1,600 and not more than 2,500 Not less than 100 and not more than 200 Not less than 1 and not more than 2 Not less than 1 and not more than 3 Not less than 0.5 and not more than 1.5 Not less than 15 and not more than 26 Not less than 1 and not more than 5

4 Not less than 5,000 and not more than 10,000 Not less than 400 and not more than 1,000 Not less than 4.5 and not more than 10 Not less than 5 and not more than 10 Not less than 1.5 and not more than 3 Not less than 45 and not more than 100 Not less than 5 and not more than 50

Vitamin D

I.U.

Vitamin B1

mg.

Vitamin B2

mg.

Vitamin B6

mg.

Niacinamide

mg.

dPantothenic acid or its alts and panthenol. Folic acid

mg.

mg.

Not less than 50 and not more than 300

Not less than 1,000 and not more than 1,500 19

Not less than 25 and not more than 100

Not less than 100 and not more than 500

44987412-613b-4366-821b-7a2f464b0dbe.doc

1 Vitamin B 12

2 mg.

3 Not less than 0.5 and not more than 1.0 Not less than 25 and not more than 50 Not less than 5and not more than 10

4 Not less than 5 and not more than 15 Not less than 75 and not more than 150 Not less than 15 and not more than 25

5 Not less than 1 and not more than 3 Not less than 20 and not more than 40 Not less than 2.5 and not more than 10

6 Not less than 1 and not more than 5 Not less than 30 and not more than 80 Not less than 5 and not more than 20

Vitamin C

mg.

Vitamin E

I.U.

Similarly it has been found in banned & bannedable drugs book written by Voluntary Health Association of India that there is not justification for combining vitamins & minerals.

Decision:

Drugs Registration Board decided to circulate the proposals amongst all the members of the Board and the matter shall be discussed in the forthcoming meeting of Drugs Registration Board for finalization of recommendations to be submitted to the government for final approval.

44987412-613b-4366-821b-7a2f464b0dbe.doc

20

ITEM NO. IV NEW APPLICATIONS RECOMMENDED FOR REGISTRATION BY THE EXPERTS. 1. Rosuvastatin S. No. 1. Name of Firm(s) M/s. Macter International, Karachi Name of Drug(s) & Composition Liprid Tablets Each film coated tablet contains:Rosuvastatin (as calcium)…20mg (Cardiovascular drug) Liprid Tablets 5mg Each tablet contains:Rosuvastatin as calcium ….5mg (Cardiovascular drug) Liprid Tablets10mg Each tablet contains:Rosuvastatin as calcium ….10mg (Cardiovascular drug) Liprid Tablets 40mg Each tablet contains:Rosuvastatin as calcium ….40mg (Cardiovascular drug) Pack Size(s) 3x10’s Demanded Price Rs.3847.77 Decision Approved

2.

-do-

3x10’s

Rs.989.44

-do-

3.

-do-

3x10’s

Rs.1927.47

-do-

4.

-do-

3x10’s

Rs.6338.82

Rejected on the grounds that maximum for the persons of Asian origin is 20mg as referred in BNF 49 & 50 Approved

5.

M/s. PharmEvo, Karachi

Rostin 5mg Tablets Each tablets contains:Rosuvastatin Calcium.……5mg (Cholesterol Lowering Agent) Rostin 10mg Tablets Each tablets contains:Rosuvastatin Calcium.…….10mg (Cholesterol Lowering Agent) Rostin 20mg Tablets Each tablet contains:Rosuvastatin Calcium.…..20mg (Cholesterol lowering agent)

10’s

Rs. 25.00/ per tablet

6.

-do-

10’s

Rs. 35.00/ per tablet

-do-

7.

-do-

10’s

Rs. 45.00/ per tablet

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

21

8.

-do-

Rostin 40mg Tablets Each tablets contains:Rosuvastatin Calcium.…….40mg (Cholesterol Lowering Agent)

10’s

Rs. 60.00/ per tablet

9.

M/s. S. J & G Fazul Ellahie (Pvt.) Ltd; Karachi

WRAP Tablets 5mg Each tablet contains:Rosuvastatin Calcium eq. to Rosuvastatin ..5mg (Lipid Lowering Agent) Wrap Tablets 10mg Each tablet contains:Rosuvastatin Calcium eq. to Rosuvastatin………..10mg (Lipid Lowering Agent) Wrap Tablets 20mg Each tablet contains:Rosuvastatin Calcium eq. to Rosuvastatin………. 20mg (Lipid Lowering Agent) Wrap Tablets 40mg Each tablet contains:Rosuvastatin Calcium eq. to Rosuvastatin ………40mg (Lipid Lowering Agent)

10’s

Rs.360.00

Rejected on the grounds that maximum for the persons of Asian origin is 20mg as referred in BNF 49 & 50 Approved

10.

-do-

10’s

Rs.650.00

-do-

11.

-do-

10’s

Rs.1100.00

-do-

12.

-do-

10’s

Rs2000.00

13.

M/s. Atco Laboratories, Karachi -do-

Rostin 10mg Tablets Each tablet contains:Rosuvastatin………10mg Rostin 20mg Tablets Each tablet contains:Rosuvastatin………20mg

10’s

Rs 1000.00

Rejected on the grounds that maximum for the persons of Asian origin is 20mg as referred in BNF 49 & 50 Approved

14.

10’s

Rs 2000.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

22

15.

M/s. Helix Pharma, Karachi

Rosatin / Rovast 5mg Tablets Each film coated tablet contains:Rosuvastatin Calcium USAN………5.50mg (Lipid Lowering Agent) Rosatin / Rovast 10mg Tablets Each film coated tablet contains:Rosuvastatin Calcium USAN……………11mg (Lipid Lowering Agent) Rosatin / Rovast 20mg Tablets Each film coated tablet contains:Rosuvastatin Calcium USAN……………….22mg (Lipid Lowering Agent) Rast 5mg Tablets Each tablet contains:Rosuvastatin Sodium……..5mg (Anti-Cholesterol) Rast 10mg Tablets Each tablet contains:Rosuvastatin Calcium ……..10mg (Anti-Cholesterol) Rast 20mg Tablets Each tablet contains:Rosuvastatin (as Rosuvastatin Calcium)...20mg (Lipid Lowering Agent ) Rast 40mg Tablets Each tablet contains:Rosuvastatin (as Rosuvastatin Calcium).…….40mg (Lipid Lowering Agent )

10’s

Rs. 280.00

-do-

16.

-do-

10’s

Rs. 550.00

-do-

17.

-do-

10’s

Rs. 990.00

-do-

18.

M/s. Tabros Pharma, Karachi

10’s

Rs. 350.00

-do-

19.

-do-

10’s

Rs. 650.00

-do-

20.

-do-

10’S

Rs. 1090.00

-do-

21.

-do-

10’S

Rs. 1950.00

22.

M/s. Hilton Pharma, Karachi

Rolip 5mg Tablets Each tablet contains:Rosuvastatin (as Rosuvastatin Calcium).….5mg (Lipid Lowering Agent ) 23

10’s 20’s

Rs. 300.00 Rs. 600.00

Rejected on the grounds that maximum for the persons of Asian origin is 20mg as referred in BNF 49 & 50 Approved

44987412-613b-4366-821b-7a2f464b0dbe.doc

23.

-do-

Rolip 10mg Tablets Each tablet contains:Rosuvastatin (as Rosuvastatin Calcium)...10mg (Lipid Lowering Agent ) Rolip 20mg Tablets Each tablet contains:Rosuvastatin (as Rosuvastatin Calcium)...20mg (Lipid Lowering Agent ) Rostin 10mg Tablets Each film coated tablets contains:Rosuvastatin Calcium. eq. to Rosuvastatin…..……10mg (Synthetic Lipid-Lowing agent) Rostin 20mg Tablets Each film coated tablets contains:Rosuvastatin Calcium. eq. to Rosuvastatin…..……20mg (Synthetic Lipid-Lowing agent) Rostin 40mg Tablets Each film coated tablets contains:Rosuvastatin Calcium. eq. to Rosuvastatin…..……40mg (Synthetic Lipid-Lowing agent)

10’s 20’s

Rs. 600.00 Rs. 1200.00

-do-

24.

-do-

10’s 20’s

Rs. 1200.00 Rs. 2400.00

-do-

25.

M/s. Bosch Pharmaceutic al, Karachi

10’s

Rs. 480.00

Approved

26.

-do-

10’s

Rs. 960.00

-do-

27.

-do-

10’s

Rs. 1920.00

Rejected on the grounds that maximum for the persons of Asian origin is 20mg as referred in BNF 49 & 50

2. NADIFLOXACIN S. No. 1. Name of Firm(s) M/s. Genix Pharma Karachi Name of Drug(s) & Composition Nadicin 10mg Cream Each gm contains:Nadifloxacin……..10mg (Quinolone Anti-Bacterial Agent) Pack Size(s) 1’s Demande d Price Rs. 150.00 Remarks Approved

44987412-613b-4366-821b-7a2f464b0dbe.doc

24

3.

TELITHROMYCIN

S. No. 1.

Name of Firm(s) M/s Hilton Pharma, Karachi

Name of Drug(s) & Composition Telmac 400mg Tablets Each tablet contains:Telithromycin…………400mg (Antibiotic)

Pack Size(s) 10’s 20’s

Demanded Price Rs.1070.00 Rs.2140.00

Remarks Approved

4.

TELMISARTAN S. No. 1. Name of Firm(s) M/s Macter International, Karachi Name of Drug(s) & Composition Kardia 20mg Tablets Each tablet contains:Telmisartan …………20mg (Antihypertensive) Kardia Tablets Each tablet contains:Telmisartan ………..40mg (Anti hypertensive) Kardia 80mg Tablets Each tablet contains:Telmisartan …………80mg (Antihypertensive) Telsan 40mg Tablets Each tablet contains:Telmisartan …………40ng (Anti-Hypertensive) Telsan 80mg Tablets Each tablet contains:Telmisartan …………80ng (Anti-Hypertensive) Tesart 40mg Tablets Each film coated tablet contains:Telmisartan………....40mg (Anti-hypertensive) Tesart 80mg Tablets Each film coated tablet contains:Telmisartan………....80mg (Anti-hypertensive) 25 Pack Size(s) 1x10’s Demanded Price Rs.371.64 Remarks Approved

2.

-do-

1x10’s

Rs.645.60

-do-

3.

-do-

1x10’s

Rs.1273.37

-do-

4.

M/s. Hilton Pharma, Karachi

14’s 28’s

Rs. 840.00 Rs. 1680.00

-do-

5.

-do-

14’s 28’s

Rs. 1540.00 Rs. 3080.00

-do-

6.

M/s. Bosch Pharmaceutic al, Karachi

14’s 28’s

Rs. 840.00 Rs. 1680.00

-do-

7.

-do-

14’s 28’s

Rs. 1582.00 Rs. 3164.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

5.

METFORMIN + ROSIGLITAZONE S. No. 1. Name of Firm(s) M/s Hilton Pharma, Karachi Name of Drug(s) & Composition Co-Dibroz 2/1000 Tablets Each tablet contains:Rosiglitazone Maleate eq. to Rosiglitazone.…2mg Metformin Hydrochloride..1000mg (Oral anti-hyperglycemic) Co-Dibroz 4/1000 Tablets Each tablet contains:Rosiglitazone Maleate eq. to Rosiglitazone.…4mg Metformin Hydrochloride..1000mg (Oral anti-hyperglycemic) Avamet 2mg/500mg Tablets Each tablet contains:Rosiglitazone (as Maleate).…2mg Metformin HCl BP.........500mg (Anti-Diabetic Agent) Avamet 4mg/500mg Tablets Each tablet contains:Rosiglitazone (as Maleate)…4mg Metformin HCl BP..........500mg (Anti-Diabetic Agent) Avamet 2mg/1000mg Tablets Each tablet contains:Rosiglitazone (as Maleate)……2mg Metformin HCl BP...........1000mg (Anti-Diabetic Agent) Rosimet 2mg/500mg Tablets Each tablet contains:-_ Rosiglitazone (as Maleate)…2mg Metformin (as HCl)……...500mg Rosimet 4mg/500mg Tablets Each tablet contains:-_ Rosiglitazone (as Maleate)…4mg Metformin (as HCl)……...500mg Pack Size(s) 14’s 28’s 56’s Demanded Price Rs. 546.00 Rs. 1092. 00 Rs. 2184.00 Remarks Approved

2.

-do-

14’s 28’s 56’s

Rs. 938.00 Rs. 1876. 00 Rs. 3752.00

-do-

3.

M/s Getz Pharma Pakistan, Karachi

14’s

Rs. 658.00

-do-

4.

-do-

14’s

Rs. 742.37

-do-

5.

-do-

14’s

Rs. 1202.55

-do-

6.

M/s. Atco Laboratories, Karachi

14’s

-do-

7.

-do-

14’s

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

26

8.

M/s Helix Pharma, Karachi

Cogliden Tablets Each tablet contains:Pioglitazone Hydrochloride……16.55mg Metformin Hydrochloride……...510mg (Anit-Diabetic agent) Cogliden Tablets Each tablet contains:Pioglitazone Hydrochloride……16.55mg Metformin Hydrochloride………1020mg (Anit-Diabetic agent) Cogliden Tablets Each tablet contains:Pioglitazone Hydrochloride……33.55mg Metformin Hydrochloride………..510mg (Anit-Diabetic agent) Cogliden Tablets Each tablet contains:Pioglitazone Hydrochloride……33.55mg Metformin Hydrochloride………1020mg (Anit-Diabetic agent) Cogliden Tablets Each tablet contains:Pioglitazone Hydrochloride.50mg Metformin Hydrochloride..510mg (Anit-Diabetic agent) Cogliden Tablets Each tablet contains:Pioglitazone Hydrochloride50mg Metformin Hydrochloride……….1020mg (Anit-Diabetic agent)

10’s

Rs. 100.00

Deferred for expert opinion

9.

-do-

10’s

Rs. 110.00

-do-

10.

-do-

10’s

Rs. 180.00

-do-

11.

-do-

10’s

Rs. 190.00

-do-

12.

-do-

10’s

Rs. 260.00

-do-

13.

-do-

10’s

Rs. 270.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

27

14.

M/s Helix Pharma, Karachi

Co-Dib 4/500 Tablets Each tablet contains:Rosiglitazone Maleate eq. to Rosiglitazone.…4mg Metformin Hydrochloride..500mg (Oral anti-hyperglycemic)

14’s 28’s

Rs.860.00 Rs.1700.00

Approved

6.

ATORVASTATIN + AMLODIPINE S. No. 1. Name of Firm(s) M/s. Atco Laboratories, Karachi Name of Drug(s) & Composition Amtor 5mg/10mg Tablets Each tablet contains:-_ Amlodipine (as Besylate)…5mg Atorvastatin (as Calcium)…10mg Amtor 5mg/20mg Tablets Each tablet contains:-_ Amlodipine (as Besylate)…5mg Atorvastatin (as Besylate)…20mg Amtor 10mg/10mg Tablets Each tablet contains:-_ Amlodipine (as Besylate)…10mg Atorvastatin (as Calcium)…10mg Amtor 10mg/20mg Tablets Each tablet contains:-_ Amlodipine (as Besylate)…10mg Atorvastatin (as Calcium)…20mg Co-Atorap 10/10 Tablets Each tablet contains:Amlodipine Besylate eq. to Amlodipine ……..10mg Atorvastatin Calcium Trihydrate eq. to Atorvastatin…….10mg (Calcium channel blocker) Co-Atorap 10/20 Tablets Each tablet contains:Amlodipine Besylate eq. to Amlodipine ……..10mg Atorvastatin Calcium Trihydrate eq. to Atorvastatin…….20mg (Calcium channel blocker) Pack Size(s) 10’s Demanded Price Rs. 225.00 Remarks Deferred for evaluation

2.

-do-

10’s

Rs. 280.00

-do-

3.

-do-

10’s

Rs. 325.00

-do-

4.

-do-

10’s

Rs. 380.00

-do-

5.

M/s Hilton Pharma, Lahore

10’s 20’s 30’s

Rs.300.00 Rs.600.00 Rs900.00

-do-

6.

-do-

10’s 20’s 30’s

Rs.600.00 Rs.1200.00 Rs1800.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

28

7.

-do-

Co-Atorap 10/40 Tablets Each tablet contains:Amlodipine Besylate eq. to Amlodipine ……..10mg Atorvastatin Calcium Trihydrate eq. to Atorvastatin…….40mg (Calcium channel blocker with lipid lowering agent)

10’s 20’s 30’s

Rs.1200.00 Rs.2400.00 Rs3600.00

-do-

8.

M/s. Helix Pharma, Karachi

Lipifal Plus Tablets 10’s Each film coated tablet contains:Atorvastatin (as Calcium) USAN……………….10mg Amlodipine (as Besylate) B.P……………………..10mg (Lipid-Lowering Agent + Calcium Channel Blocker) Lipifal Plus Tablets 10’s Each film coated tablet contains:Atorvastatin (as Calcium) USAN…………..20mg Amlodipine (as Besylate) B.P……………..10mg (Lipid-Lowering Agent + Calcium Channel Blocker) Lipifal Plus Tablets 10’s Each film coated tablet contains:Atorvastatin (as Calcium) USAN…40mg Amlodipine (as Besylate) B.P…………...10mg (Lipid-Lowering Agent + Calcium Channel Blocker)

Rs. 260.00

-do-

9.

-do-

Rs. 590.00

-do-

10.

-do-

Rs. 960.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

29

7.

EZETIMIBE + SIMVASTATIN S. No. 1. Name of Firm(s) M/s. Novins Int. Karachi Name of Drug(s) & Combination Zecol-S Tablets Each tablet contains:Ezetimibe………….10mg Simvastatin USP…..10mg (HMG-CoA ) (Reductase inhibitor / lipid lowering compounds) Zecol-SD Tablets Each tablet contains:Ezetimibe………….10mg Simvastatin USP…..20mg (HMG-CoA ) (Reductase inhibitor / lipid lowering compounds) Zecol-ST Tablets Each tablet contains:Ezetimibe………….10mg Simvastatin USP…..40mg (HMG-CoA ) (Reductase inhibitor / lipid lowering compounds) LogiCol Tablets Each tablet contains:Ezetimibe…………10mg Simvastatin USP…..20mg (Antihyperlipidemic) LogiCol Tablets Each tablet contains:Ezetimibe…………10mg Simvastatin USP…..40mg (Antihyperlipidemic) Mezet 10/10mg Tablets Each tablet contains:Ezetimibe………10mg Simvastatin…….10mg (Lipid Regulating gent / Hypercholestrolaemic) Pack Size(s) 7’s Demanded Price Rs. 500.00 Decision Approved

2.

-do-

7’s

Rs. 800.00

-do-

3

-do-

7’s

Rs. 1500.00

-do-

4

M/s. Barrett Hodgson, Karachi.

10’s

Rs. 700.00

-do-

5

-do-

10’s

Rs. 850.00

-do-

6

M/s. Helix Pharma, Karachi

10’s 20’s

Rs. 860.00 Rs. 1700.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

30

TEM NO. V Following cases were deferred in 193rd - (A) Meeting of Me-Too Committee held on 29th September, 2005 for consideration of Drugs Registration Board.:S. No. Name of Firm(s) Name of drug(s) & Composition Pack Size(s) Demanded Price Decision

1.

M/s. Lexicon, Karachi

Difen SR tablet Each tablet contains Diclofenac sodium..100mg (Anti-rheumatics)

30's 100’s

RS. 250.00 RS. 600.00

Deferred for submission of pharmaceutical data of formulation including stability studies and pharcomacokinetic data by the firm for expert evaluation Deferred till the finalization of vitamin policy

2.

-do-

Multilex tablet Each coated tablet contains Vit B1………………..10mg, VIT B2……………….10mg Vit B6…….……………3mg Niacinamide………..50mg Folic Acid……………1mg Vitamin B12……………5mcg Calcium Pantothenate.... 25mg (Mineral & Vitamins)

1000's

RS. 180.00

3.

-do-

Multilex Syrup Each 5ml contains Vitamin B1……2mg Vitamin B2…2.5mg Vitamin B6…2.5mg Vitamin B12…3mcg Niacinamide….50mg D-Panthenol….5mg Color Carmosine Flavor Syrup Base..q.s (Multivitaqmin Preparation) 31

120ml 450ml

RS. 35.00 RS. 50.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

4.

-do-

Anodyne Tablet Each chewable tablet contains Calcium. Carbonate…125mg (calcium supplement, dental development) Anodyne Plus Tablet Each tablet contains Calcium. Carbonate..125mg Vit D…………………125iu (calcium supplement, dental development) Calceecon Sachet Calcium Carbonate. 600mg Vitamin C ………1000mg (Calcium supplement)

30's

RS. 75.00

Rejected due to reason that calcium carbonate is not absorbed from the gut Approved

5.

-do-

10's

RS. 45.00

6.

-do-

1 x 10 sachet

RS. 47.88

-do-

7.

-do-

Lactus Couth Syrup Each 5ml contains Pseudoephedrine HCl....30mg Dextromethorphan HBr..10mg Triprolidine HCl……..1.25mg Sodium Citrate…………..60mg Menthol…………………..1mg Color Amarnath…………Q.S. Flavored Syrup…………Q.S (Cough Suppressant)

60ml 100ml 450ml

RS. 35.00 RS. 26.00 RS. 110.00

-do-

8.

-

do –

Hepalex 250 Capsule Each Capsule contains Betaine Glucuronate …250mg Ethanolamine Glucuronate…………….30mg Nicotinamide………….8.2mg (Colagogues & Hepatic Preparations)

20’s

RS. 53.00

Deferred till the finalization of vitamin policy

44987412-613b-4366-821b-7a2f464b0dbe.doc

32

9.

-

do –

Hepalex Syrup Each 100ml contains Betaine Glucuronate ...37.50gm Ethanolamine Glucuronate…………….10gm Nicotinamide…………200gm (Colagogues & Hepatic Preparations)

100ml

RS. 75.00

-do-

10.

-do-

Isotek Capsule Each capsule contains Isotretinoin…………….20mg (Vitamin A Derivative) Isotek Capsule Each capsule contains Isotretinoin…………….10mg (Vitamin A Derivative)

5’s

RS. 350.00

Approved

11.

-do-

5’s

RS. 200.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

33

12.

M/s Zafa Pharmaceuti cals, Karachi DML No.000470

Amzavit Infusion Each 100ml contains:D-Sorbitol ………….10.00gm DL-Malic Acid ……0.295gm Sodium Acetate Anhydrous ………..0.2662gm Magnesium Chloride 6H2O …………….0.0523gm Potassium Hydroxide 0.1524gm L-Isoleucine …………0.320gm L-Leucine ……………0.240gm L-Lysine HCl ………..0.250gm L-Methionine ………..0.300gm L-Phenylalanine ……..0.400gm L-Threonine …………0.200gm L-Valine ……………0.320gm L-Arginine HCl …….0.266gm L-Arginine …. …….0.400gm L-Histidine HCL H2O 0.135gm L-Alanine ……………0.600gm Glycine (Aminoacetic Acid) …………1.400gm L-Proline ……………0.200gm Sodium Bisulfite …….0.033gm L-Tryptophan ………..0.105gm Ascorbic Acid ……….0.050gm Inositol ……………..0.055gm Nicotinamide ………0.0072gm Pyridoxine HCl ……0.0048gm Riboflavin Sodium Phosphate ……….0.0003gm Water for Injection q.s to …………..100ml (Aminoacides supplement / nutritional)

100ml 500ml

150.00 310.00

Deferred till the finalization of vitamin policy

13.

M/s S.J & G Fazul Ellahie, Karachi

Felje-D Extended Release Tablets Each film coated tablet contains:Fexofenadine HCl …….60mg Pseudoephedrine HCl ...120mg (Anti allergic)

1x10’s

118.00

Deferred for submission of pharmaceutical data of formulation including stability studies and pharcomacokinetic data by the firm for expert evolution

44987412-613b-4366-821b-7a2f464b0dbe.doc

34

14.

M/s Barrett Hodgson, Karachi

GenCart Plus Capsuels Each capsule contains:Glucosamine Sulphate USP…………………. .500mg Chondroitin Sulphate USP ………………....200mg Calcium Carbonate ……75mg Ascorbic Acid ………….25mg (Anti rheumatic drug) Enamor Tablets Each tablet contains: Sildenafil Citrate…..25mg (Supplementary drugs & other substances)

10’s

165.00

Deferred till the finalization of vitamin policy

15.

M/s. Tabros Pharma, Karachi

1’s

Rs. 600.00

Deferred for clinical trials and it was also decided that all the new applications of this category shall be kept pending in the sections instead of putting them on the agenda. -do-

16.

-do-

Enamor Tablets Each tablet contains: Sildenafil Citrate…..50mg (Supplementary drugs & other substances) Enamor Tablets Each tablet contains: Sildenafil Citrate…..100mg (Supplementary drugs & other substances)

1’s

Rs. 800.00

17.

-do-

1’s

Rs. 1000.00

-do-

18.

M/s. Sami Coxim Mouth Dissolving Pharmaceuti Tablets cal, Karachi. Each Dispersible Tablet contains:Nimesulide…..100mg (Non-steroidal antiinflammatory drug)

20’s

Rs. 100.00

Deferred for submission of pharmaceutical data of formulation including stability studies and pharcomacokinetic data by the firm for expert evaluation

19.

-do-

Sacrim Solid Oral Dosage Powder in Sachets Each sachet contains:_ Saccharomyees Boulardii (Lyophilized) MS…250mg (Probiotic yeast)

10’s

Rs. 234.00

Rejected due to dubious efficacy

44987412-613b-4366-821b-7a2f464b0dbe.doc

35

20.

M/s. Nabiqasim Industries, Karachi

Viviron Plus Syrup Each 100ml contains:Ferric Ammonium Citrate USP………………...900mg Folic Acid USP…..….10mg Vitamin B1 USP….…20mg Vitamin B6 USP……..40mg Nicotinamide USP….200mg Liquid Glucose USP…q.s. (Iron + Vitamin) Romyo 25mg Tablets Each film coated tablet contains:Sildenafil (as citrate) eq. to Sildenafil………25mg (Phosphodiesterase type 5 inhibitors)

240ml

Rs. 69.00

Deferred till the finalization of vitamin policy

21.

-do-

10’s

Rs. 400.00

Deferred for clinical trials and it was also decided that all the new applications of this category shall be kept pending in the sections instead of putting them on the agenda. -do-

22.

-do-

Romyo 50mg Tablets Each tablet contains:Sildenafil (as citrate) eq. to Sildenafil……..50mg (Phosphodiesterase type 5 inhibitors) Romyo 100mg Tablets Each film coated tablet contains:Sildenafil (as citrate) eq. to Sildenafil………100mg (Phosphodiesterase type 5 nhibitors) Asco-CT 100mg Tablets Each chewable tablet contains:Ascorbic Acid………..100mg (Vitamin C tablet) Multivit Tablets Each sugar coated tablet contains:Vitamin A…………….2500 i.u Vitamin D2…………....300 i.u Thiamine Hydrochloride….1mg Riboflavin……………....0.5mg Nicotinamide……….…..7.5mg Ascorbic Acid………......15mg (Multivitamins) 36

10’s

Rs. 600.00

23.

-do-

10’s

Rs. 1200.00

-do

24.

-do-

1000’s

Rs. 230.00

Approved

25.

-do-

1000’s

Rs. 350.00

Deferred till the finalization of vitamin policy

44987412-613b-4366-821b-7a2f464b0dbe.doc

26.

-do-

Biohope 200mg Tablets Each film coated tablet contains:Silymarin…….200mg (Liver protecting substance) Biohope Plus Capsules Each capsule contains:Silymarin…………….105mg Vitamin B1…………….8mg Vitamin B2…………….8mg Vitamin B6……………..8mg Vitamin B12………….25mcg Nicotinamide…………..24mg Calcium Pantothenate…..16mg (Liver protecting substance with vitamins) Biohope Plus Suspension Each 5ml contains:Silymarin…………….105mg Vitamin B1…………….8mg Vitamin B2…………….8mg Vitamin B6……………..8mg Vitamin B12………….25mcg Nicotinamide…………..24mg Calcium Pantothenate…..16mg (Liver protecting substance with vitamins) Hexavit Syrup Each ml contains:L-Ornithine L- Aspartate..60mg Nicotinamide……….…4.8mg Riboflavin 5- Phosphate Sodium……………….0.153mg {(Drug acting on liver and gal blander (Amino acid combination)} Silmar 200mg Tablets Each tablet contains:Silymarin………200mg (Cholagogues & Hepatic Preparation)

15’s 30’s

Rs. 85.00 Rs. 165.00

Approved

27.

-do-

30’s

Rs. 220.00

Deferred till the finalization of vitamin policy

28.

-do-

60ml 120ml

Rs. 50.00 Rs. 90.00

-do-

29.

M/s. Medicure Labs, Karachi.

120ml

Rs. 125.00

-do-

30.

-do-

10’s 20’s

Rs. 70.00 Rs. 125.00

Approved

31.

M/s. Novins OsteoCor 5mg Tablets Int. Karachi Each tablet contains:Alendronic Acid ….5mg (as Alendronate Sodium) (Bisphosphonate) 37

1x10’s

Rs. 150.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

32.

-do-

OsteoCor 10mg Tablets Each tablet contains:Alendronic Acid ….10mg (as Alendronate Sodium) (Bisphosphonate) OsteoCor 70mg Tablets Each tablet contains:Alendronic Acid ….70mg (as Alendronate Sodium) (Bisphosphonate) Foxi -DTablets Each film coated tablet contains:Fexofenadine HCl……...60mg Pseudoephedrine HCl….120mg (Antihistamies, systemic) Liverest Syrup Each 5ml contains:L-Ornithine Aspartate..300mg Nicotinamide ………....24mg Riboflavin 5 Phosphate ………………….….0.765 mg (Alimentary Tract & Metabolism) Levocit 10mg Tablets Each film coated tablet contains:Levocetirizine Dihydrochloride……10.00mg (Antialergic agent)

1x10’s

Rs. 300.00

-do-

33.

-do-

1x10’s

Rs. 1000.00

-do-

34.

M/s. NOA Hemis, Karachi

1x10’s

Rs. 84.10

-do-

35.

-do-

60ml 120ml

Rs.50.50 Rs.97.50

Deferred till the finalization of vitamin policy

36.

M/s. Brookes Pharmaceuti cal, Karachi.

1x10’s

Rs. 175.00

Deferred for expert evaluation

37.

M/s. Bosch Dalafil 5mg Tablets Pharmaceuti Each film coated tablet cal, Karachi. contains:Tadalafil………….5.25mg (5% overage) (Erectile Dysfunction)

10’s 20’s

Rs. 682.50 Rs. 1365.00

Deferred till the finalization of policy

38.

-do-

Dalafil 10mg Tablets Each film coated tablet contains:Tadalafil…………..10.50mg (5% overage) (Erectile Dysfunction)

10’s 20’s

Rs. 1837.50 Rs. 3675.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

38

39.

-do-

Dalafil 20mg Tablets Each film coated tablet contains:Tadalafil…………….21mg (5% overage) (Erectile Dysfunction)

10’s 20’s

Rs. 3675.00 Rs. 7350.00

-do

40.

M/s. Amros Amtaje Capsules Pharmaceuti Each capsule contains:cal, Karachi Beta-Carotenen……..9mg Zinc Monomethionine Complex……………10mg Selenium……….…0.02mg Alpha Tocopherol….100mg Ascorbic Acid……..500mg (Vitamin & Antianaemic) M/s. Genix Pharma, Karachi. Denfil 25mg Tablets Each tablet contains:Sildenafil Citrate…....25mg (Eractile Dysfunction)

3x10’s

Rs. 147.00

Deferred till the finalization of vitamin policy

41.

50’s

Rs. 7500.00

- Deferred for clinical trials and it was also decided that all the new applications of this category shall be kept pending in the sections instead of putting them on the agenda. -do-

42.

-do-

Denfil 50mg Tablets Each tablet contains:Sildenafil Citrate…....50mg (Eractile Dysfunction) Denfil 100mg Tablets Each tablet contains:Sildenafil Citrate…....100mg (Eractile Dysfunction)

50’s

Rs. 12500.00

43.

-do-

50’s

Rs. 17500.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

39

44.

M/s. Mediate Pharma, Karachi

Megnovit Tablets Each tablet contains:Vit. A……………..…6000 iu Vit. D………………....500 iu Vit. E………………..…15mg Vit. C……………….…100mg Vit. B1………………....1.6mg Vit. B2………………....1.8mg Nicotinamide…………..19mg Vit. B6…………………2.6mg Vit. B12……………….4mcg Pantothenate…………...10mg Folic cid……………….0.8mg Biotin…………………….2mg Calcium Elemental)…..125mg Iron Elemental)………….60mg Magnessium Elemental.)100mg Copper (Elemental)………1mg Zinc lemental)…………7.5mg Magnese lemental)………1mg Phosphorous lemental)...125mg (Multivitamin, Multiminral supplement) Medibi Capsules Each capsule contains:Vit. A…………………2400 iu Vit. D………………..….240 iu Vit. E………………..….2mg Vit. C……………….…40mg Vit. B1………………....2.5mg Vit. B2………………...2.5mg Nicotinamide…………....20mg Vit. B6…………………....1mg Vit. B12……………….4.9mcg Calcium Pantothenate….100mg Lecithin..………………..9.5mg (Vitamin supplement) Iprofen 800mg Sustained Released Tablets Each tablet contains:Ibuprofen……..800mg (Anti-inflammatory)

30’s

Rs. 199.00

Deferred till the finalization of vitamin policy

45.

-do-

15x5’s

Rs. 650.00

-do-

46.

M/s. Platinum Pharmaceuti cal, Karachi

20’ 30’s

Rs. 125.00 Rs. 188.00

Deferred for submission of pharmaceutical data of formulation including stability studies and pharcomacokinetic data by the firm for expert evaluation

44987412-613b-4366-821b-7a2f464b0dbe.doc

40

47.

M/s. Abbott Synthroid 50mcg Tablets Laboratories Each tablet contains:Karachi Levothyroxine Sodium ..50mcg M/s. Deluxe Chemical Indus, Karachi M/s. Opal Labs, Karachi Silynum Suspension Each 5ml contains:Silymarin …………….105mg (Liver protector) Torrasam-Vit Tablets Each tablet contains:Ferrous Sulphate…….150mg Folic Acid……….0.5mg Thiamine HCl…2.00mg Riboflavin……2.00mg Nicotinamide…….10mg Pyridoxine HCl…….00mg Ascorbic Acid……..50mg (Haematinic/Vitmain) 60ml 120ml Rs.55.00 Rs.100.00

Approved

48.

Approved

49.

3x10’s

Rs.76.00

Deferred till the finalization of vitamin policy

44987412-613b-4366-821b-7a2f464b0dbe.doc

41

ITEM NO. V1 Following cases were rejected in 193rd - (A) Meeting of Me-Too Committee held on 29th September, 2005 for consideration by the Committee of different firms which were rejected:S. No. Name of firm(s) Lexicon pharmaceuticals (pvt.) Ltd. Karachi Name of Drugs Pack Size(s) Demanded Price RS. 75.00 Decision

1.

Lexitran Syrup Each 5ml syrup contains Trimethoprim ………....40mg Sulphamethoxazole…..200mg (Broad spectrum antibiotic)

450ml

Deferred for verification HVAC system, cleaning validation and campaign manufacturing.

2.

-do-

Dexalex Tablet Each tablet contains Dexamethasone….0.5mg (Corticcosteroids)

1000's

RS. 270.00

Rejected on the grounds that the firm did not posses the separate Hormonal Section

3.

-do-

Clarilex Suspension Each 5ml contains Clarithromycin…125mg (Broad spectrum antibiotic)

60ml 90ml

RS. 230.00 RS. 340.00

Rejected on the grounds that the firm did not posses separate General Antibiotic Dry Syrup Section as identified by the CL & RB.

44987412-613b-4366-821b-7a2f464b0dbe.doc

42

4.

-do-

Oxylexin Capsule Each capsule contains Oxytetracycline…250mg (Broad spectrum antibiotic)

100’s 500’s 1000’s

RS. 80.00 RS. 350.00 RS. 650.00

Deferred for verification HVAC system, cleaning validation and campaign manufacturing.

5.

M/s Semos Levoquine Tablets 250mg Pharmaceuticals Each tablet contains:, Karachi Levofloxacin …….250mg (Antibiotics)

1x10’s

415.00

Deferred for verification HVAC system, cleaning validation and campaign manufacturing. -do-

6.

-do-

Levoquine Tablets 500mg Each tablet contains:Levofloxacin …….500mg (Antibiotics) Gatix Tablets 200mg Each tablet contains:Gatifloxacin ……….200mg (Fluoroquinolones) Gatix Tablets 400mg Each tablet contains:Gatifloxacin ……….400mg (Fluoroquinolones)

1x10’s

820.00

7.

-do-

10’s

Leader price

-do-

8.

-do-

10’s

Leader price

-do-

9.

M/s Alkemy Wormnil Elixir Pharmaceuticals Each 5ml contains:, Karachi Piperazine citrate eq. to Piperazine citrate.... 750mg (Threadworm)

30ml

6.18 60ml 450ml

Rejected on the grounds that the preparation is Neurotoxicity and withdrawn in a number of counties. It was also suggested that the Drug Registration Board shall also review already registered preparations

44987412-613b-4366-821b-7a2f464b0dbe.doc

43

10.

-do-

Kemyclox 500mg Capsules Each capsule contains:Amoxicillin Trihydrate eq. to Amoxicillin base ………..500mg (Broad spectrum and penicillin)

20’s

140.00

Rejected on the grounds that the firm is not licensed for manufacturing of Penicillin Deferred for verification HVAC system, cleaning validation and campaign manufacturing. Rejected on the grounds that the firm did not possess separate sachet section. Moreover, this preparation is not registered in the reference countries. Rejected due to Neurotoxicity and it is suggested that already registered formulations may also be reviewed Rejected and referred for review of already registered formulation by Drugs Registration Board and review of other registered formulations

11.

M/s Platinum Noviclar XL Tablets 500mg Pharmaceuticals Each tablet contains:, Karachi Clarithromycin………500mg (Macrolides)

5’s 10’s

323.71 647.42

12.

- M/s. Farmaceutics, Karachi

Nimilide Granules Each sachet contains:Nimuslide…..100mg (Analgesic and antipyratic )

10’s

Rs. 90.00

13.

M/s. Zanctok Ziperazine Syrup Pharmaceutical, Each 5ml contains:Hyderabad Piprazine Citrate…..625mg (Anthelmintic)

1x30ml

Rs. 11.00

14. M/s. Nabiqasim Industries, Karachi

Mavicol Suspension Each 5ml contains:Chloramphenicol Palmitate eq. to Chloramphenical Base…125mg (Anti-Infective)

60ml

Rs. 35.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

44

15.

M/s. Indus Pharma, Karachi

Exlor 375mg Tablet Each tablet contains:Cefaclor…375mg (Antibacterial)

8’s

Rs. 230.00

Rejected on the grounds that the firm did not possess dedicated cephalosporin tablet section -do-

16.

-do-

Exlor 750mg Tablet Each tablet contains:Cefaclor…750mg (Antibacterial)

8’s

Rs. 502.00

17. M/s. Novins Int. NoviBaxin Suspension Karachi Each 5ml contains (after reconstitution):Clarithromycin USP…….125mg (Antibiotic, macrolide)

60ml

Rs. 300.00

Rejected on the grounds that the firm did not posses separate General Antibiotic Dry Syrup Section Rejection due to safety concern. I t was also decided to review the already registered formulations -do-

18.

M/s. Brookes Fantrin Tablets Pharmaceutical, Each film coated tablet contains:Karachi. Halofantrine HCl……...250mg (Antimalarial)

1x6’s

Rs. 220.00

19.

-do-

Fantrin Suspension Each 5ml contains:Halofantrine HCl……...100mg (Antimalarial) Calamine Lotion Each 100ml contains:Calamine……….15% Zinc Oxide……….5% Bentonite…………3% Sodium Citrate….0.5% Liquid Phenol…..0.5% Glycerin…………5% (Dermatological)

30ml

Rs. 140.00

20.

M/s. Risma Labs, Karachi

?

?

Rejected because the firm did not posses facility for manufacturing of external preparations

44987412-613b-4366-821b-7a2f464b0dbe.doc

45

21.

-do-

Gripe Water Each 150ml contains:Aqua Anethi Cocentrate BPC……………………....3.6% Sodii Bicarbonas BP……...1.0% Syrupus………………....22.50% Spiritus Rectificatus BP…4.92% (Children’s gripe water)

?

?

Rejected being irrational formulation. It was also suggested to review the already resisted preparation if any Rejected because the firm did not posses facility for manufacturing of external preparations

22.

-do-

Tincture Iodine Solution Each 100ml contains:Potassium Iodide………….2.50gm Iodine……………2.05% Sppecially Denatured Spirit…50ml Distilled water…………...qs (Antiseptics) Gentian Violet Each 100ml contains:Gentian Violet crystals..……1.0% Sppecially Denatured Spirit..10.0% Distilled water………….……..qs (Antiseptics) Mercurochrome Solution Contains:Mercurochrome..……2.0% Distilled water………….……..qs (Antiseptics) Castor Oil Flavoured Contains:Castor Oil..…..50ml (Purgative / laxative) Surgical Spirit Each 100ml contains:Diethyl Phthalate……….…..2.0% Castor Oil………………..…2.5% Methyl Salicylate…………..0.5% Specially Denatured Spirit…..qs (Antiseptics) 46

?

?

23.

-do-

?

?

-do

24.

-do-

?

?

-do

25.

-do-

?

?

-do

26.

-do-

?

?

-do

44987412-613b-4366-821b-7a2f464b0dbe.doc

27.

-do-

Liquid Paraffin Each 100ml contains:Liquid Paraffin BP……100ml (Purgative / laxative) Ichthammol Ointment Each 100gm contains:Ichthammol ……10% Inert Base………90% (Purgative / laxative)

?

?

-do

28.

-do-

?

?

-do

29.

M/s. Geofman Moxiquin Tablets Pharmaceutical, Each film coated tablet contains:Karachi Moxifloxacin Hydrochloride..400mg (Flouroquinolone Antibacterial)

1x5’s

Rs. 500.00

Deferred for verification HVAC system, cleaning validation and campaign manufacturing. Rejected being irrational formulation

30.

M/s. Indus Pharma, Karachi

Co-codaprin Tablets Each tablet contains:_ Codeine Phosphate….8mg Aspirin……………400mg (Analgesic & antipyretic) 1x5’s Rs. 690.00

31.

M/s. Semos Moxacin 400mg Tablets Pharmaceutical, Each tablet contains:Karachi. Moxifloxacin…….400mg (Antibiotics, Quinolones)

Deferred for verification HVAC system, cleaning validation and campaign manufacturing. -do-

32.

-do-

Sparcin 100mg Tablets Each tablet contains:Sparfloxacin…….100mg (Antibiotics, Quinolones) Buscomed Tablets Each tablet of the product contains:-Hyoscine Butylbromide……..10mg Paracetamol…………….500mg (Antispasmodic, anticholinergics)

1x10’s

Rs. 550.00

33.

M/s. Mediate Pharma, Karachi

10x10’s

Rs. 140.00

Rejected being irrational formulation. It was also decided that the Drugs Registration Board shall also review the already

44987412-613b-4366-821b-7a2f464b0dbe.doc

47

registered formulations of this category.

34.

M/s. Geofman Gatoxin 200mg Tablets Pharmaceutical, Each film coated tablet contains:Karachi Gatifloxacin (as Gatifloxacin Seaquihydrae)….……..200mg (Anti-bacterial agent)

10’s

Rs. 132.00

35.

-do-

Gatoxin 400mg Tablets Each film coated tablet contains:Gatifloxacin (as Gatifloxacin Seaquihydrae)….……..400mg (Anti-bacterial agent)

10’s

Rs. 259.00

Deferred for verification HVAC system, cleaning validation and campaign manufacturing. -do-

36.

M/s. Epoch Tisol Topical Liquid Pharmaceutical, Each 100ml liquid contains:Karachi Ciclopirox Olamine USP…..01.50% (Anti-fungal)

60ml

Rs. 140.00

Rejected due to non availability of separate section for the manufacturing of external preparations Deferred for verification HVAC system, cleaning validation and campaign manufacturing. Rejected due to toxicity

37.

M/s. Getz Pharma, Karachi

Claritek XL 500mg Tablets Each film coated tablet contains:Clarithromycin USP..….500mg (Broad spectrum antibiotic)

5’s

Rs. 274.99

38.

M/s. Deluxe Dee-Phenicol Suspension Chemical Indus, Each 5ml contains:Karachi Chloramphenicol..125mg (Anti bacterial)

60ml 120ml

Rs.19.00 Rs.70.00

39. M/s Noa Hemis, Matox Suspension Karachi Each 5ml contains:Magnesium hydroxide ….250mg Aluminium Hydroxide …..250mg Simithicone …...50mg Oxethazaine ….10mg (Antacid)

120ml

Rs.25.00

Rejected being irrational formulations

44987412-613b-4366-821b-7a2f464b0dbe.doc

48

40.

-do-

Muconol Syrup Each 100ml contains:Chlorpheniramine Maleate.100mg Terpinhydrate..200mg Pot. Bicarbonate ……..2mg Ammonium Chloride.500mg Tr. Senega ………….1.0ml Menthol …….20mg Bromhexine Hcl …….20mg Ephedrine HCl ……..100mg Pot. Guaicol Sulph …..100mg Pot. Citras ……………2mg Tr. Ipecac ……0.5ml Ext. Glycyrrhiza Liq. …..2ml (Respiratory System)

100ml

Rs.22.00

Rejected being irrational formulations. It was also suggested that Registration Board should review already registered formulation of this category.

41. M/s. Opal Labs, Roxib Tablets Karachi Each tablet contains: Rofecoxib……..25mg (Coxib, Nsaid/ Analagesic) 42. -doRoxib Tablets Each tablet contains: Rofecoxib……..12.5 mg (Coxib, Nsaid/ Analgesic)

10’s

Rs.784.00

Rejected due to safety concern

10’s

Rs.416.50

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

49

43.

M/s S.J & G Fazul Ellahie, Karachi

Co-gesic Tablets Each tablet cantons:Dextropropoxyphene HCl..32.5mg Paracetamol…….325mg (Analgesic)

10x10’s

Rs.112.00

Rejected due to reported adverse effects resulting in respiratory deprassion and acute heart failure due to Dextropropoxy phene and Hepatoxicity due to Paracetamol especailly in over dosage. Co-proxamal is to be withdrawn from the market and the CSM has advised that Co-Proxamal should no longer be prescribed, patients who are already receiving it should have reviewed their Treatment with another analgesic. The Registration Board decided that show cause notice shall be issued to the already registered formulation of this category.

44987412-613b-4366-821b-7a2f464b0dbe.doc

50

Following cases were rejected in 195th - (A) Meeting of Me-Too Committee held on 4th January, 2006 for consideration by the Committee of different firms which were rejected:S. No. Name of Manufacturer M/s. K.P.L. Karachi Name of drug(s) with Composition Epidine 30mg Tablets Each tablet contains:Ephedrine Hydrochloride……30mg (Bronchial Astham) Erni 150mg Capsules Each capsule contains:Erdosteine……….150mg {Mucolytic (treatment of chronic obstructive disorder)} Brotab Tablets Each tablet contains:Bromelain….20,000units Crystaline Trypsin………2500units (Anti-Inflammatory Enzyme) Pack size 1000’s Demanded Price Rs. 272.63 Decision

44.

Deferred for clarification of strength whether already registered or otherwise. -do-

45.

M/s. Hilton Pharma, Karachi

10’s 20’s

Rs. 81.50 Rs. 163.00

46.

M/s. Krka-Pak, Karachi

24’s 500’s

Rs. 50.00 Rs. 390.00

Rejected because of distraction of protein enzymes in the stomach these drugs have placebo effect and to review the already registered formulations by issuing show cause notices Rejected because of distraction of protein enzymes in the stomach these drugs have placebo effect -do-

47.

M/s. Tabros Pharma, Karachi

Serra Tablets Each enteric coated tablet contains:Serratiopeptidase….5mg (Anti-Inflammatory & Anti-Tumefacient) Serra DS Tablets Each enteric coated tablet contains:Serratiopeptidase…10mg (Anti-Inflammatory & Anti-Tumefacient) Muselax 4mg Capsules Each capsule contains:Thiocolchicoside…4mg (Muscle Relaxant and Decontracturant) 51

2x10’s

Rs. 55.30

48.

-do-

2x10’s

Rs. 105.80

49.

M/s. Nabiqasim, Karachi

20’s

Rs. 438.00

Deferred for clarification of strength whether already registered or otherwise.

44987412-613b-4366-821b-7a2f464b0dbe.doc

50.

M/s. Swiss Pharma, Karachi

Cloroquin Injection Each ml contains:Chloroquine Phosphate 64.5mg eq. to Chloroquine Base…….40mg (Anti-Malarial)

5mlx100’s ampoules

Rs. 195.00

Rejected due to toxicity of chloroquine in the children

44987412-613b-4366-821b-7a2f464b0dbe.doc

52

ITEM NO. VII Approval of recommendations of 195ht meeting of Me-Too Committee about the following drugs. S. No. Name of Name of drug(s) with Manufacturer Composition M/s. Tabros Pharma, Karachi Gospel Tablets Each tablet contains: Glimepride…..1mg (Anti diabetic) Gospel Tablets Each tablet contains: Glimepride…..2mg (Anti diabetic) Gospel Tablets Each tablet contains: Glimepride…..3mg (Anti diabetic) Gospel Tablets Each tablet contains: Glimepride…..4mg (Anti diabetic) Brease Tablets Each film tablet contains: Zafirlukast….…..10mg (Antagonist of Leukotriene) Brease Tablets Each film tablet contains: Zafirlukast….…..20mg (Antagonist of Leukotriene) Ceftrix 250mg Injection When reconstituted (as directed ) each vial contains:Ceftriaxone Sterile Powder BP/USP (as Sodium salt).250mg (Cephalosporin) Ceftrix 1g Injection When reconstituted (as directed ) each vial contains:Ceftriaxone Sterile Powder BP/USP (as Sodium salt) …….1000mg (Cephalosporin) 53 Pack size 2x10’s Demanded Price Rs.125.00

1.

2.

-do-

2x10’s

Rs.245.00

3.

-do-

2x10’s

Rs.350.00

4.

-do-

2x10’s

Rs.480.00

5.

-do-

14’s

Rs.286.00

6.

-do-

14’s

Rs.575.00

7.

M/s. Nawan Labs, Karachi

Vial

Rs. 95.00

8.

-do-

Vial

Rs. 300.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

9.

-do-

Ceforin 250mg Injection When reconstituted (as directed ) each vial contains:Cefotaxime Sterile Powder BP/USP (as Sodium salt) …….250mg (Cephalosporin) Ceforin 500mg Injection When reconstituted (as directed ) each vial contains:Cefotaxime Sterile Powder BP/USP (as Sodium salt) …….500mg (Cephalosporin) Lorestin Tablets Each tablet contains:Loratadine..…….10mg (Antihistamine) Vebracin Capsules Each capsule contains:Doxycycline Hyclate (as Hemihydrate Hemiethenolate)……..100mg (Broad spectrum antibiotic) Vitasin Syrup Each 5ml contains:Thiamine HCl……….…4.16mg Riboflavin 5 Phos-sod….1.66mg Pyrideoxine HCl………..1.00mg Niacinamide…………18.00mg D-Panthenol…………..2.50mg Cyancobalamin………8.33mcg Ascorbic Acid…….75.00mg Chloride……………….33.33mg Inositol………………….5.00mg (Broad spectrum antibiotic)

Vial

Rs. 76.00

10.

-do-

Vial

Rs. 120.00

11.

-do-

10’s

Rs. 115.00

12.

-do-

2x10’s

Rs. 120.00

13.

-do-

120ml

Rs. 25.00 Deferred for policy decision

14.

M/s. Elko Organization, Karachi

Levocin Tablets (alternate name Bestoflox / Bestolev) Levofloxacin……..500mg (Quinolone, Anti-bacterial)

1x10’s

Rs. 400.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

54

15.

M/s. Efroze Chemical, Karachi

Fexadin Tablets Each tablet contains:Fexofenadine Hydrochloride…60mg (Anti-Histaminic & antiBacterial) Zomax Tablets Each film coated tablet contains:Zolmitriptan….…5mg (Anti-Migraine) Arip 15mg Tablets Each tablet contains:Aripiprazole……..15mg (Anti-Depressants) Fexofen 120mg Tablets Each film coated tablet contains:Fexofendine HCl……..120mg (Proton pump inhibitor) Vasodil Tablets Each tablet contains:Isosorbide Dinitrate B.P …5mg Vasodil Tablets Each tablet contains:Isosorbide Dinitrate B.P….10mg Herpovir Tablets Each tablet contains:Acyclovir….………..…..400mg (Anti-Viral) Glizone Tablets Each film coated tablet contains:Rosiglitazone Maleate eq. to Rosiglitazone MS….……..4mg (Anti-Diabetic) Glizone Tablets Each film coated tablet contains:Rosiglitazone Maleate eq. to Rosiglitazone MS….……..8mg (Anti-Diabetic) 55

10’s

Rs. 100.00

16.

-do-

3’s

Rs. 1335.00

17.

M/s. Nabiqasim, Karachi

30’s

Rs. 2010.00

18.

M/s. Medicaids, Karachi

10’s

Rs. 110.00

19.

M/s. Roomi Enterprises, Karachi -do-

100’s

Rs. 28.00

20.

100’s

Rs. 34.00

21.

-do-

35’s

Rs. 3485.00

22.

M/s. Genix Pharma, Karachi

14’s

Rs. 1125.00

23.

-do-

14’s

Rs. 1600.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

24.

-do-

Lejont 10mg Tablets Each tablet contains:Leflunomide….……..10mg Lejont 20mg Tablets Each tablet contains:Leflunomide….……..20mg Lejont 100mg Tablets Each tablet contains:Leflunomide….……..100mg Piotab 15mg Tablets Each tablet contains:Pioglitazone HCL eq. to Pioglitazone….……..15mg (Anti-Diabetic) Piotab 30mg Tablets Each tablet contains:Pioglitazone HCL eq. to Pioglitazone….……..30mg (Anti-Diabetic) Piotab 45mg Tablets Each tablet contains:Pioglitazone HCL eq. to Pioglitazone….……..45mg (Anti-Diabetic) Borovate-N Cream Each 100 gm contains:Betamethasone Dipropionate (eq. to Betamethasone Base…….0.0525gm Neomycin Sulphate……….1gm Linopril-H Tablets Each tablet contains:Lisinopril Dinhydrate eq. to Lisinopril U.S.P……………..20mg Hydrochlorothiazide U.S.P..12.5mg (Anti-Hypertensive)

30’s

Rs. 450.00

25.

-do-

30’s

Rs. 650.00

26.

-do-

30’s

Rs. 1100.00

27.

-do-

10’s 30’s

Rs. 100.00 Rs. 300.00

28.

-do-

10’s 30’s

Rs. 168.00 Rs. 504.00

29.

-do-

10’s 30’s

Rs. 224.00 Rs. 672.00

30.

-do-

5gm 15gm

Rs. 12.50 Rs. 35.00

31.

M/s. Efroze Chemical, Karachi

20’s

Rs. 450.00

Decision:

Drugs Registration Board confirmed the recommendations of Me-Too Committee.

44987412-613b-4366-821b-7a2f464b0dbe.doc

56

TEM NO. VIII NEW AAPPLICATIONS FOR REGISTRATION S. No. 1. Name of Firms(s) M/s. Mediate Pharmaceutical, Karachi Name of drug(s) & Composition Bmflu 75mg Capsules Each capsule contains:Oseltamivir as Oseltamivir Phosphate………..75mg (Antiviral) Ozenta 75mg Capsules Each capsule contains:Oseltamivir as Oseltamivir Phosphate………..75mg (Antiviral) Ozenta 12ml Dry Suspensin Each ml contains:Oseltamivir as Oseltamivir Phosphate………..12mg (Antiviral) Pack Size(s) 10’s Demanded Price Rs. 2300.00 Decision Approved

2.

M/s. Hilton Pharma, Karachi

10’s 20’s

Rs. 1500.00 Rs. 3000.00

-do-

3.

-d-

100ml

Rs. 1800.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

57

TEM NO. VIII-A NEW AAPPLICATIONS FOR REGISTRATION S. No. 1. Name of Firms(s) M/s. Bayer Pakistan, Karachi Name of drug(s) & Composition Ciproxin XR 500mg Tablets Each film coated tablet contains:Ciprofloxacin Hydrochloride Monohydrate Pharmaceutical. Eur. USP 334.8mg and Ciprofloxacin Hydrous 253.0mg Corresp. To Ciprofloxacin……500mg (Import in bulk from M/s. Bayer HealthCare AG Leverkusen, Germany and repacked locally) 3’s 5’s 7’s Pack Size(s) 3’s 5’s 7’s Demanded Price Rs. 235.03 Rs. 390.56 Rs. 546.08 Remarks Deferred for submission of pharmaceutical data of formulation including stability studies and pharcomacokine tic data by the firm for expert evaluation -do-

2.

-do-

Ciproxin XR 1000mg Tablets Each film coated tablet contains:Ciprofloxacin Hydrochloride Monohydrate Pharmaceutical. Eur. USP 669.4mg and Ciprofloxacin Hydrous 506.0mg Corresp. To Ciprofloxacin……1000mg (Import in bulk from M/s. Bayer HealthCare AG Leverkusen, Germany and repacked locally)

Rs. 511.28 Rs. 850.96 Rs. 1190.65

3.

M/s. Hilton Pharma, Karachi

Hiclor MR 750mg Tablets Each tablet contains:Cefaclor Monohydrate eq. to Cefaclor……………750mg Tritace 10mg Tablets Each tablet contains:Ramipril ……….10mg (ACE Inhibitor) (Import in bulk from Aventis Pharma, Italy and repacked locally)

8’s

Rs. 474.15

-do-

4.

M/s Aventis Pharma, Karachi

10’s

Rs. 1252.00

Deferred due to paucity of time

44987412-613b-4366-821b-7a2f464b0dbe.doc

58

5.

M/s. Bayer Pakistan, Karachi

Trasylol Infusion Solution Each vial contains:Aprotinin concentrated solution 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)

50ml 100ml 200ml

Rs. 4,056.00 Rs. 7,701.77 Rs. 13,472.07

-do-

6.

M/s. Zafa Pharmaceutical, Karachi Mfg. Lic. 000513

Artesul Tablets for adults Each small tablet contains:Artesunate……..100mg Each large tablet contains:Sulfadoxine…………500mg Pyrimethamine……….25mg (Anti-Malarial) Artesul Tablets for adults Each small tablet contains:Artesunate……..50mg Each large tablet contains:Sulfadoxine…………500mg Pyrimethamine……….25mg (Anti-Malarial)

1x9’s

Rs. 105.00

-do-

7.

-do-

1x8’s

Rs. 60.00

-do-

44987412-613b-4366-821b-7a2f464b0dbe.doc

59

32.

M/s. Efroze Chemical, Karachi

Fexadin Tablets Each tablet contains:Fexofenadine Hydrochloride…60mg (Anti-Histaminic & antiBacterial) Zomax Tablets Each film coated tablet contains:Zolmitriptan….…5mg (Anti-Migraine) Linopril-H Tablets Each tablet contains:Lisinopril Dinhydrate eq. to Lisinopril U.S.P……………..20mg Hydrochlorothiazide U.S.P..12.5mg (Anti-Hypertensive)

10’s

Rs. 100.00

33.

-do-

3’s

Rs. 1335.00

34.

-do-

20’s

Rs. 450.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

60

EXTRACT TAKEN FROM MINUTES OF 196

TJ

MEETING OF DRUG REGISTRATION

BOARD HELD ON 22ND – 23RD FEBRUARY, 2006. (REG-II-SOUTH)
1. M/s Semos Levoquine Tablets 250mg Pharmaceuticals Each tablet contains:, Karachi Levofloxacin …….250mg (Antibiotics) 1x10’s 415.00 Deferred for verification HVAC system, cleaning validation and campaign manufacturing. -do-

2.

-do-

Levoquine Tablets 500mg Each tablet contains:Levofloxacin …….500mg (Antibiotics) Gatix Tablets 200mg Each tablet contains:Gatifloxacin ……….200mg (Fluoroquinolones) Gatix Tablets 400mg Each tablet contains:Gatifloxacin ……….400mg (Fluoroquinolones) Moxacin 400mg Tablets Each tablet contains:Moxifloxacin…….400mg (Antibiotics, Quinolones)

1x10’s

820.00

3.

-do-

10’s

Leader price

-do-

4.

-do-

10’s

Leader price

-do-

5.

-do-

1x5’s

Rs. 690.00

Deferred for verification HVAC system, cleaning validation and campaign manufacturing. -do-

6.

-do-

Sparcin 100mg Tablets Each tablet contains:Sparfloxacin…….100mg (Antibiotics, Quinolones)

1x10’s

Rs. 550.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

61

EXTRACT TAKEN FROM MINUTES OF 196TJ MEETING OF DRUG REGISTRATION BOARD HELD ON 22ND – 23RD FEBRUARY, 2006. (REG-II-SOUTH)
VITAMIN POLICY Drugs Appellate Board has directed in its 124th sitting held on 10th November, 2005 that the Drugs Registration Board should formulate comprehensive policy for the vitamins & minerals. It was also said that in some of the countries they are being regulated and in other countries these are being treated as food supplements. As far as vitamins and minerals are concerned it is submitted that it is strongly objected that there is misuse and overuse of vitamins & minerals and most of the products registered are irrational and there is wastage of money of poor people. These drugs are having lack of evidence of effectiveness and in appropriate effects are in appropriate combinations and doses. 1. In this regard BNF 49 March, 2005 edition states that vitamins are used for prevention and treatment of specific deficiencies states are where diet is to be inadequate. But not as dietary supplements there use as general “pick me ups” is of unproven value and in case of preparations containing vitamins A or D may be harmful if patient takes more than the prescribed dose. The fad for megavitamins therapy with water-soluble vitamins such as ascorbic acid and pyridoxine is unscientific and can be harmful. Bangladesh banned certain vitamin preparations on the grounds that this wastage of money of people and these are irrational stating following guidelines:a) Vitamins should be prepared as single ingredients except B-complex. b) Vitamins will not be allowed to be combined with any other ingredient such as minerals and glycerophosphate etc. c) It will be allowed that vitamins shall be produced only in tablets capsules and injectable forms. d) No liquid will be permitted because of wastage of financial resources and tremendous misuse involved. e) However, pediatric liquid of vitamins will be allowed to be manufactured in 15ml bottles only. f) Combination of vitamins with analgesic or antibiotics will not be allowed except combination of pyridoxine with INH.

2.

g) Vitamins & antacid preparations will be manufactured only by local pharmaceutical firms. 3. India in October, 1999 banned the fixed dose combinations of Vitamin B1, B6 & B12 for human use with effect from January, 2001. They also Notified standards for formulations containing vitamins that patent are proprietary medicines containing vitamins for prophylactic, therapeutic or pediatric use shall contain vitamins in the vitamins in the quantities not less than and not more than specified below in single or in two divided doses daily. 62

44987412-613b-4366-821b-7a2f464b0dbe.doc

EXTRACT TAKEN FROM MINUTES OF 196TJ MEETING OF DRUG REGISTRATION BOARD HELD ON 22ND – 23RD FEBRUARY, 2006. (REG-II-SOUTH)
1. M/s. Brookes Pharmaceuti cal, Karachi. Levocit 10mg Tablets Each film coated tablet contains:Levocetirizine Dihydrochloride……10.00mg (Antialergic agent) Fantrin Tablets Each film coated tablet contains:Halofantrine HCl……...250mg (Antimalarial) 1x10’s Rs. 175.00 Deferred for expert evaluation

2.

-do-.

1x6’s

Rs. 220.00

Rejection due to safety concern. I t was also decided to review the already registered formulations -do-

3.

-do-

Fantrin Suspension Each 5ml contains:Halofantrine HCl……...100mg (Antimalarial)

30ml

Rs. 140.00

44987412-613b-4366-821b-7a2f464b0dbe.doc

63

EXTRACT TAKEN FROM MINUTES OF 196TJ MEETING OF DRUG REGISTRATION BOARD HELD ON 22ND – 23RD FEBRUARY, 2006. (REG-II-SOUTH)
Decision: The representative of the firms were called for personal hearing on 23rd February, 2005 on the direction of honorable Sindh High Court, Division Bench, Karachi for reconsideration of rejected applications of Galenicals products and they were asked to come with clinical justification / supportive data in their defence keeping in view the reasons of rejection conveyed to them through rejection letters by the Ministry of Health. Mr. Abid Hameed Puri, Advocate appeared on behalf of following firms:5. 6. 7. 8. M/s. Medicure Labs, Karachi M/s. Regent Labs, Karachi M/s. K.P.L. Karachi. M/s. Gaba Pharma, Karachi

He also submitted wakalet nama duly signed by the said firms along with a written reply and as the firms were asked to bring clinical justification and supportive data regarding the registration of Galinicals keeping in view the reasons of rejection already conveyed to them through rejection letters dated 12th November, 2005;1. Do not bear any therapeutic indications / use. 2. Bear misuse potential as intoxicant liquor. 3. Concentrations of Alcohol in the formulations is not clinically recommended and are not safe. 4. Better alternatives with established safety and efficacy as compared to this drugs are available in the market. 5. All the expert members of the Board unanimously decided that this formulation is not required in the best public interest. “The counsel submitted written reply the grounds of rejection are completely whimsical, arbitrary and indicate a complete lack of application of mind to the available facts and data on the file, the previous history and the present status vis-avis, the pharmacopeial information etc, it was also stated as the requirement of justice demand that a party called jupon to suffer consequences of any propose action should be provided with relevant particular and documents to controvert and rebut the allegation and the proposed action. We hereby request mentioned at provided with specific information and documents vis-avis the reasons mentioned at S. No. 4 & 5 of the grounds of rejection, namely, as to what better alternatives with established
44987412-613b-4366-821b-7a2f464b0dbe.doc

64

safety and efficacy as compared to these drugs are available in the market. And, to be provided with the opinions / decisions of the expert members of the Board on the basis whereof it has been decided that the formulation is not required in the best public interest and onus of information of clinical justification and supportive data for the rejection lies on the Ministry of Health. They reserve their rights to submit their view point and explanation to refute and impugn such grounds in writing upon receiving the requisite information and details.That with regards the first three grounds we submit as follows:Regarding ground No. 1, namely, that these products do not bear any therapeutic indication / use, they invite reference to the fact that the Central licensing Board under its letter bearing No. F. 7-4A/76-QC (Lic), dated 26th June, 1978, and subsequent letters bearing No. F. 9-17/92-Lic (M-103) dated 17/08/1993, 16/11/1993, 29/02/1993, and 16/01/1994 etc., had been specifically approving the manufacture of these Galenicals.

That thereafter, under SRO No. 877 (1)/2000, dated 9/12/2000as communicated under letter No. F. 9-5/2000 (LIC), dated 11th January, 2001, by the Deputy Drugs Controller, Galenical items were required to be registered like other formulation drugs, and applications along with requisite fee of Rs. 8000/- for registration were to be made within 30 days, and if no such applications were received, the approvals granted earlier would be deemed to have been terminated.

Accordingly, in the context, on the one hand a consistent policy was pursued by the Ministry of Health for the continued manufacture of Galenicals, and in fact, they were deemed worthy of being registered like other formulation drugs, which exfacie established that these products had and have therapeutic use / utility, and on the other hand, such letter dated 11/01/2001, conveys the conveys the continuity of permission for manufacturing of Galenicals, subject to making the application for registration within 30 days.

That in the comments submitted under your signature in Writ Petition No. D-1227/2005, at annexure-B, a list of 15 Galenical items approved by the Central Licensing Board is filed and annexure-D, with such comments shows Tinctures and spirits which are subject of an individual monograph in the British Pharmacopoeia. That the British Pharmacopoeia, United States Pharmacopoeia and the British Pharmacopeutical codex, till date, in addition to the Indian Pharmacopoeia, carry these Tinctures, extracts, etc., in their monographs and also declare their actions and uses in the various and different physical conditions.

44987412-613b-4366-821b-7a2f464b0dbe.doc

65

In view of such position, the Ministry of Health is stopped from questioning in any manner the therapeutic indications / uses of these Galenicals, and indeed the burden of establishing, proving that these Galenicals do not bear any therapeutic use, in the light of conduct and admission made by the Ministry and the overwhelming international literature available, would be on the body or person asserting to the contrary. Accordingly, you may provide us with any plausible or cogent basis to dispute the therapeutic use and indications of these items.

With regards ground No. 2, namely, that these items bear misuse potential as intoxicants / liquor, it is respectfully submitted that the alcohol used in these products is as a solvent to extract the ingredients, and is in accordance with the procedure provided under the various pharmacopoeias.

That as may be known, Galenical pertains to the ancient system of medicine taught and practiced by Galenus or Galen; and Galenicals are medicines prepared according to the formulas of Galen, which term is now used to denote standard preparations containing one of several organic ingredients, as contrasted with pure chemical substances.

There can be no misuse of the actual Galenical products as Intoxicants / liquor and such misuse can only occur, if any unscrupulous manufacturer sells off the permitted alcohol acquired by him, without putting it to use in the preparation of the product, for which purpose the Excise officials maintain a record and inventory and which in ordinary course may not be possible if persons act in good faith.

Regarding ground No. 2, namely, that concentration of alcohol in the formulation are not clinically recommended and are not safe, it is submitted that the same is a totally baseless, illogical and imaginary ground as the concentrations are as per prescribed formulation given in the various pharmacopoeias, and are not dependent on the whims and fancies of any individual manufacturer.

That in any event, in the counter-affidavit filed by Mr. Ahmed Din Ansari, Federal Inspector of Drugs, Karachi, in Writ Petition No. D-1227/2005, in para 6A, he has declared Tincture Benzoin Co, surgical spirit, Tincture Iodine, and Tincture Kenocort as Galenical drugs which could not be misused, whereas alcohol content in these drugs ranges from 90-95% and establishes that the statement in such ground has not been bonafidely made. That as the manufacture of Galenical items had continued throughout, and in 2001, applications for registration were sought, these grounds, if at all, would have been available or applicable, had there been a 44987412-613b-4366-821b-7a2f464b0dbe.doc 66

change in the circumstances since 2001, which may have caused new grounds to reconsider the propriety of manufacture and use of Galenicals, based whereon these grounds for refusing registration could have been raised.

As the same circumstances have existed throughout, these grounds have no merit whatsoever, and in addition to the principle of estoppel being applicable to the raising of these grounds to refuse registration, the same would also be hit by the principles of locus-poenetentiae as the government had called upon and acted on the basis of the drugs being worthy of registration and on the basis of the government action, the answering respondents had submitted their application for registration. The Ministry thus cannot retract in the present mater unless is drastic change in the circumstances.

That the action being nearly 5 years after the submission of registration applications, reeks of malafides and bias, and is contrary to the consistent policy, practice and procedure adopted in such matters, and is thus bad at law.

It may be added that internationally there is a clear move towards organic and natural substances being used whether in foodstuff etc., and in such circumstances Galenicals being extracted from natural herbs deserve to be supported vis-à-vis synthetic elements which have a much higher and substantial risk of harmful side effects and reactions.

There must be due emphasis on indigenous production so that through research the traditional indigenous system of treatment may advance and develop.

In the above stated facts and circumstances, whilst they again request to be provided the particulars and details regarding the grounds raised at S. Nos. 4 and 5, based on the available literature, data and practice, there is no merit, justification or rationale for either refusing registration or questioning of status of Galenicals as substantive medical preparations. The reply submitted by the honorable counsel on behalf of applicants was not supported with any clinical justification or any supportive data regarding the safety efficacy and other parameters which are mandatory to be furnished by the person applying for registration as required under Section 7 (7)of Drugs Act, 1976 which clearly states that

44987412-613b-4366-821b-7a2f464b0dbe.doc

67

“A person applying for the registration of a drug shall furnish such information in respect of the drug as may be prescribed, including information relating to its efficacy safety and quality, or as may be required by the Registration Board for the purpose of evaluation of drug”.

The counsel was asked that the pharmacopia gives only specifications of the drugs enlisted in it which deal with the testing method, limits for approval and analysis of drugs. For example rectified alcohol (96%) and heroin (Diacetylmorphine) both are monograph in pharmacopias and it does not gives right of registration to the applicants in this form nor alcohol is registered any where in the World as drug. The clinical data regarding the safety and efficacy is provided by the applicants which consists of the following parameters and was asked to reply the following queries:9. After clinical trials evidence in the form of data it is proved that the drug is safe for use in the given doses.

10. That the drug applied for registration is effective against such and such diseases along with evidence of clinical trials and / or scientific justification through publication in the well known research journals or standard reference book of pharmacology, medicine and pharmacy. 11. Assessment of dose through clinical trials that the drug is effective in such doses and schedule of doses as well as period of treatment of disease is also proved with data. 12. Prescribing information like indications, contraindications, side effects and precautions are also given for applied drug which are to be evaluated by the Drugs Registration Board experts for approval. 13. Alternative medicines which are available in the market are safe and effective as compared to the these products containing vegetables extracts used for symptomatic treatment. 14. The maximum alcoholic contents clinically permissible for oral use is below 20% because the alcohol itself have pharmacological properties in addition to its solvent property. While the maximum alcoholic contents permissible under the excise act is 45% in various beverages. While on the other hand all the above applied formulations contain alcoholic content above the permissible limits of 45% and in a number of cases above 80%. 15. The alcoholic content is abused as intoxicant liquor instead of treatment. 16. The other ingredients, which are added in these drugs to develop the finished products, were not imported by these manufacturers during the last one year and quota of alcohol was claimed as admitted by the applicants in the petition, which is sufficient to believe that alcohol is misused and actual products are not produced. 44987412-613b-4366-821b-7a2f464b0dbe.doc 68

The counsel failed to reply these queries and satisfied the Drugs Registration Board. Moreover, Mr. Hanif Billo and Mr. Baber Mahmood, representing PCDA & PPMA respectively as observers also stated that Galenicals are misused as liquor intoxicants by the drinkers and are popular as kuppies in the market instead of there use for the purpose of treatment. The Board also informed the counsel that those Galenicals which are safe and effective and are meant for external use to be applied on the skin are being registered. For example Tincture, Iodine, Tincture Benzoin. Co and Surgical spirit. These could not also be taken as intoxicant liquor due to contents of the formulations. The honorable counsel requested some time instead of rejection of applications. The Drugs Registration Board after listening the arguments of the counsel and statements of observers unanimously rejected these applications of four firms under the Rule 29 (9) of Drugs (Licensing, Registering & Advertising) Rules, 1976 on the above mentioned grounds.

44987412-613b-4366-821b-7a2f464b0dbe.doc

69


				
DOCUMENT INFO
Shared By:
Categories:
Tags:
Stats:
views:568
posted:10/29/2009
language:English
pages:69