ORDER S.K. Jha, C.J. 1. In this petition under Articles 226 and 227 of the Constitution of India, the petitioners have prayed for quashing of the notifications as incorporated in Annexure A-9 and A-10 as being arbitrary, unauthorized, discriminatory and in violation of Section 26-A of the Drugs and Cosmetics Act, 1940 (Act No. 23 of 1940), (hereinafter referred to as the Act), as also in violation of Articles 14 and 19 (1) (g) of the Constitution of India, being discriminatory and wholly unreasonable. 2. Petitioner No. 1 is a private limited Company, registered under the Companies Act. Petitioner No. 2 is its permanent Managing Director. The petitioners are engaged in the manufacture, sale and distribution of drugs and medicines under licenses issued by respondent No. 3, Controller and Licensing Authority in the State of M. P. Licenses are issued by respondent No. 3 for biological preparations in Form No. 28 and for non biological preparations in Form No 25, as prescribed by the Rules framed under the Act. The petitioners are holders of License Nos. 28/6/88 in Form No. 28 and 25/8/88 in Form No. 25 which have been marked as Annexure A/3 and A/4 to the writ petition. The biological license Annexure A-3 permits manufacture for sale of specified drug formulations contained in Schedules C and C-1 under the Drugs and Cosmetics Rules, 1945, whereas the license Annexure A-4 authorizes manufacture for sale of specified drug formulations other than those in Schedule C and C-1 and these drug formulations are described as non-biological drug preparations Under the biological drug manufacturing license annexure A-3, the petitioners are authorized by respondent No 3 to manufacture for sale biological drug formulations as per the list of items attached thereto which forms part of the said license and one such drug formulation is 'Maxiphos F-12' syrup. The petitioners are further authorized to manufacture for sale the following products under the license in Form No 25: (a) HONHAR BABY TONIC (b) MAXICAL-P SYRUP. Drug formulation Honhar Baby Tonic is manufactured for sale under the initial license mentioned for sale under the initial license mentioned at S. No. 1 of the list of items attached to it, whereas drug formulation Maxical-P Syrup is authorized to be manufactured for sale by respondent No. 3 by a subsequent permission as per order dated 12-5-91, a true copy whereof has been marked as Annexure A-5.
The combination of the petitioners' biological drug 'Maxiphos F 12' syrup contains the following ingredients : MAXIPHOS F 12' SYRUP Each 5 ml. contains : Vitamin B1 IP 1 00.mg Vitamin B2 IP 1.00 mg Vitamin B6 IP 0.50 mg Vitamin B12 IP 1.00 mg Niacinamide Calcium IP 15.00 mg Glycerophosphate Sodium BPC 40.00 mg Glycerophosphate BPC 40.00 mg Flavored Syrupy Base to Q S. The combination of petitioners' non-biological Drug formulations 'Honhar Baby Tonic' and 'Maxical-P' Syrup is common as : MAXICAL-P AND HONHAR BABY TONIC Each 10 ml contains-- Calcium Gluconate IP 70 mg Calcium Lactate IP 80 mg Calcium Hypophosphite BPC 20 mg Calcium Glycerophosphate BPC 20 mg Palatable flavored base to Q. S. The printed cartons of the said two drug formulations are Annexure A-7 and A-8. 3. Section 26-A of the Act authorizes the Central Govt., respondent No. 1 in the Ministry of Public Health and Family Welfare, to prohibit specific medicinal formulation or formulations or drug or cosmetic if it is satisfied that the use of the said drug or cosmetic is likely to involve any risk to human beings or animals or that any drug does; not have the therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is therapeutic justification and that in the public interest, if it is necessary or expedient so to do, the Central Government, respondent No. 1 may, by notification in the official gazette, ban the manufacture, sale or distribution of such drug or cosmetic. 4. Respondent No. 2 is the Drugs Controller of India and is the Head of the Drugs Consultative Committee constituted by the Central Govt. u/s. 5 of the Act. It is admitted on all hands that there is a High Power Subcommittee of the Drugs Consultative Committee for weeding out harmful/ irrational/ineffective fixed dose -combinations in various drugs. This is a High Power Committee consisting of nine members to whom a reference shall be made hereinafter. The aforesaid Sub Committee sends its minutes of the deliberations held to the Drugs Consultative Committee which in its turn, considers the items which have been examined by the Sub-Committee and were discussed by the members. The Drugs Consultative Committee thereafter sends its comments to the Drugs Technical Advisory Board which is the final recommending Body on whose recommendations, the Union Govt.
The Drugs Consultative Committee thereafter sends its comments to the Drugs Technical Advisory Board which is the final recommending Body on whose recommendations, the Union Govt. issues the notifications banning the manufacture or use of various drugs. It is also admitted by the petitioners that their products, namely Honhar Baby Tonic, Maxical-P Syrup and Maxiphos F12 Syrup contain glycerophosphate sodium, glycerophosphate, calcium glycerophosphate and calcium hypophosphite. 5. From me affidavit filed on behalf of respondent No. 1, Union of India in the Ministry of Health and Family Welfare and the Drugs Controller India, respondent No. 2, duly sworn by the Dy. Drugs Controller India, it appears that there is no scientific report or data to prove the therapeutic justification in adding glycerophosphate in a tonic, as they are not of any therapeutic value. The impugned drugs containing glycerophosphates only add to the plethora of drugs formulation of questionable value. According to the reply based upon technical medical knowledge and pharmacology, glycerophosphates, are available in this country only in oral liquid preparation. The Central Govt. for the purpose of survey, screening and identifying irrational harmful drugs formed a Sub-Committee consisting of Professors of Pharmacology and Medicines under the Chairmanship of the Commissioner Food and Drug Administration, Maharashtra State. The list of such irrational and harmful fixed dose combinations were notified after getting the opinion of the Drug Industry and ratification by Drugs Technical Advisory Board which is a statutory Apex Body constituted u/s. 5.(1) of the Act. 6. It is apparent from Ex. II, annexed to the reply of the respondents that the minutes of the 7th meeting of the Sub-Committee of the Drugs Consultative; Committee for weeding out harmful/irrational/ineffective fixed dose combinations held on 7th and 7th October 1988 at Barodara, was attended by: (i) Dr M. A. Patel, Commissioner, Food and Drugs Administration, Gujarat State, Gandhinagar as the Chairman. (ii) Dr. H. H. Siddique, Associate Professor of Pharmacology, A I. I. M S., Member, New Delhi. (iii) Dr. J. P. Wali, Assistant Professor of Medicine, A. I. I. M. S., New Delhi, Member. (iv) Dr. M. Farooque, Associate Professor of Orthopedics, A. I. I. M. S., New Delhi, Member. (v) Dr. Bhavana Doshi, Consultant Pharmacologist, 251, Dr. Dada-bhai Nauroji Road, Bombay, Co-opted Member. (vi) Dr. O. D. Gulathi, Dean, Medical College, Varanasi, Co-opted Member. (vii) Dr. A. D. Joseph, Pali Hill Road, Bombay, Co-opted Member. (viii) Dr.
(iv) Dr. M. Farooque, Associate Professor of Orthopedics, A. I. I. M. S., New Delhi, Member. (v) Dr. Bhavana Doshi, Consultant Pharmacologist, 251, Dr. Dada-bhai Nauroji Road, Bombay, Co-opted Member. (vi) Dr. O. D. Gulathi, Dean, Medical College, Varanasi, Co-opted Member. (vii) Dr. A. D. Joseph, Pali Hill Road, Bombay, Co-opted Member. (viii) Dr. P. Das Gupta, Dy. Drugs Controller (India), Directorate General of Health Services, New Delhi, Co-opted Member. (ix) Shri S. M. Sharma, Technical Officer (Drugs), Directorate General of Health Services, New Delhi, Member Secretary. In Item No. 15 of the Minutes, it has been stated as : Tonic Preparations to contain Vitamins --'Prophylactic' or 'Therapeutic' content of the vitamins as per Schedule 'V' of the Drugs and Cosmetics Rules and such preparations not to contain glycerophosphates other phosphates or any other CNS stimulants and should not contain alcohol unless it can be proved that alcohol is added as a solvent for some of the permitted class of drugs in such preparations. 7. From Ex. II. it also appears that the Drug Industry was represented at the meeting of the Sub-Committee by such manufactures as M/S Merind, M/S Hoechst and East India Pharmaceuticals. These Minutes of the 7th meeting of the Subcommittee of the Drugs Consultative Committee were then placed before the Drugs Consultative Committee which held its 26th meeting at New Delhi, on 14th and 15th September 1989 and the Drugs Consultative Committee made its own recommendations with regard to tonic preparations and recommended that the Committee agreed with the recommendations made by the Experts that the tonic preparations of glycerophosphates or other phosphates or in every UNS stimulant, alcohol should not be permitted as there is no rationality for inclusion of these preparations. 8. The matter was then placed before the Drags Technical Advisory Body which is the Apex Body consisting of specialists in the different branches of physical health and hygiene. At the 41st meeting of the Drugs Technical Advisory Board held at New Delhi on 9-3-90, the Experts on the subject who constituted the Advisory Board, were : (i) Dr. A. K. Mukherjee, Incharge Director General of Health Services, New Delhi, Chairman. (ii) Dr. Anji Reddy, Managing Director, Dr. Reddy's Laboratories Ltd., Begumpet, Hyderabad, Member. (iii) Shri Ramanbhai B. Patel, M/S Cadila Laboratories Pvt. Ltd., Vetwa Road, Ghodsar, Mani-Nagar, Ahmedabad, Member. (iv) Dr. H. H. Siddique, Associate Professor, Dept.
A. K. Mukherjee, Incharge Director General of Health Services, New Delhi, Chairman. (ii) Dr. Anji Reddy, Managing Director, Dr. Reddy's Laboratories Ltd., Begumpet, Hyderabad, Member. (iii) Shri Ramanbhai B. Patel, M/S Cadila Laboratories Pvt. Ltd., Vetwa Road, Ghodsar, Mani-Nagar, Ahmedabad, Member. (iv) Dr. H. H. Siddique, Associate Professor, Dept. of Pharmacology, All India Institute of Medical Sciences, New Delhi, Member. (v) Dr. B. N. Dhawan, Director, Central Drugs Research Institute, Lucknow, Member. (vi) Dr. A. D. Nadkarni, Govt. Analyst, Drugs Control Laboratory, Food and Drug Administration, Maharashtra, Bombay, Member (vii) Dr. B. K. Roy, Director, Central Drugs Laboratory, Calcutta, Member. (viii) Smt. Janki Reddy, Govt. Analyst, Andhra Pradesh, Hyderabad, Member. (ix) Dr. P. N. Bhat, Director, Indian Veterinary research Institute, Near Bareilly, U. P., Member. (x) Dr. M. A. Patel, Commissioner, Food and Drug Administration, Gujarat State, Ahmedabad, Special Invitee. This Apex body, after having considered the recommendations of the Drugs Consultative Committee regarding weeding out irrational/harmful/ineffective fixed dose combinations, after having applied its mind, concurred with the recommendations of the Drugs Consultative Committee to weed out the following fixed dose combinations : Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and/or CNS stimulants and such preparations containing, alcohol more than 20 proof. When this final recommendation of the Drugs Technical Advisory Board was received by the Government, the drug containing glycerophosphates and/or any other phosphates and/or CNS stimulants and alcohol 20 proof (which means 20 net proof) was banned by a gazette notification of the Union Government which is the subject matter of challenge. 9. Learned counsel for the petitioners submitted that glycerophosphates or other phosphates are of therapeutic value in tonics and that the impugned gazette notification of respondent No. 1, based on the recommendations of the Apex Body, namely The Drugs Technical Advisory Board, is not correct We are afraid, we are not in a position to sit in judgment over the recommendations of such a High power Technical Body, namely Professors, Consultants, pharmacologists, Orthopedics in the Directorate General Health Services brought from all over India, forming the Drugs Technical Advisory Board. Treading such a forbidden path by us or for that matter any Court would be very hazardous from the point of view of health and hygiene of the citizens of India, contrary to the directive principles of State policy. 10.
Treading such a forbidden path by us or for that matter any Court would be very hazardous from the point of view of health and hygiene of the citizens of India, contrary to the directive principles of State policy. 10. In this connection, it is noteworthy to make a reference to the judgment of the Supreme Court dated 3-3-19987 in Writ Petition No. 3492/ 83 Vincent Panikulangara v. Union of India and others) wherein it was held as under: The technical aspects which arise for consideration in a matter of this type cannot be effectively handled by a Court. Similarly the question of policy which is involved in the matter is also one for the Union Government keeping the best of interests of citizens in view to decide. Further, the Central Government, on the basis of the expert advice, adopt and approve national policy and prescribe an adequate number of formulation which would, on the whole, meet the requirement of the people at large. 11. It is also worthwhile to mention in this regard that the Industry was represented by M/S Merind, M/S Hoechst and East India Pharmaceuticals which are Druggists and Pharmacologists of the Higher order in the country. Therefore, we cannot take open ourselves the function of overriding the recommendations of the Drugs Technical Advisory Board, the Apex Body, on whose recommendations, the impugned notification was issued by the Central Government, respondent No. 1. Indeed, any interference by us by sitting in judgment over the recommendations of such a Technical and Expert Body, would be hazardous for the citizens of India. When, therefore, it is said that liquid oral tonic preparations containing glycerophosphates or other phosphates or CNS stimulants do not have any therapeutic rationale that should be the end of the matter. The Expert Bodies have held and recommended that glycerophosphates or for that matter any other type of phosphate including the central nervous stimulants, is of no therapeutic value. That should be good enough for holding that the Central Govt. acting upon the recommendations of such highly specialized professionals, did not commit any illegality in issuing the impugned notification. 12. The next submission made by the learned counsel for the petitioners is to the effect that apart from the glycerophosphates or other phosphates, or any central nervous system stimulant must also contain 20 proof alcohol before it could be banned.
acting upon the recommendations of such highly specialized professionals, did not commit any illegality in issuing the impugned notification. 12. The next submission made by the learned counsel for the petitioners is to the effect that apart from the glycerophosphates or other phosphates, or any central nervous system stimulant must also contain 20 proof alcohol before it could be banned. We are of the view that the impugned notification issued, when in Item No. 41 it talks of banning the preparations in question of the petitioners, is quite in keeping with the letter and spirit of the notification. While issuing the notification in the Gazette of India Extraordinary, dated 13-2-1991, it is stated therein that the Central Govt. was satisfied that the use of the drug specified in the table below were likely to involve risk to human beings or purported to be claimed for them or contained ingredients and in such quantity for which there is no justification and is necessary and expedient in the public interest to do so and thereafter Item No. 41 comes in the following terms : Liquid oral tonic preparations containing glycerophosphates and/or other phosphates and/or central nervous system stimulants and such preparations containing alcohol more than 20 proof. This evidently means that this item No. 41 consists of 4 parts, namely; (i) liquid oral tonic preparations containing glycerophosphates; (ii) liquid oral tonic preparations containing other phosphates; (iii) liquid oral tonic preparations containing central nervous system stimulants; and (iv) liquid oral tonic preparations containing alcohol more than 20 proof. The interpretation put upon this clause by the Drugs Controller who has issued guidelines for the use of the Department concerned as well as the pharmacologists, is neither improper nor illegal. The Drugs Controller has construed the item in its right perspective keeping in view the fact that whereas the Subcommittee of the Drugs Consultative Committee did not say with regard to any percentage of alcohol nor for that matter, did the Drugs Consultative Committee say anything with regard to such a percentage, the Apex Body, namely the Drugs Technical Advisory Board, after due application of mind, has fixed the dose of alcohol to a maximum limit of 20 proof. One can take judicial notice of the fact that any drug containing, alcohol more than 20 proof is, by itself, hazardous enough.
One can take judicial notice of the fact that any drug containing, alcohol more than 20 proof is, by itself, hazardous enough. Therefore, the Drugs Controller has correctly construed the recommendation and the gazette notification based upon such a recommendation of the Drugs Technical Advisory Board. There is thus no substance in the submission of the learned counsel for the petitioners that any tonic, apart from containing any amount of glycerophosphate or other phosphates or nervous system stimulants, must also contain 20 proof alcohol. 13. Learned counsel for the petitioners also submitted that the Drugs Controller was not competent to put a glass over item No. 41 hereinbefore quoted. As we have earlier held, the Drugs Controller has committed no mistake in construing Item No. 41 in the manner that he has done. The question of his jurisdiction or competence and authority does not, therefore, arise, nor can it be said that the gazette notification of respondent No. 1, the Central Government, Ministry of Public Health and Family Welfare, was issued without application of mind. It would bear repetition to state that the recommendation of the Apex Body, namely the Consultative Committee, was the basis of issuance of such a notification. Therefore, to say that the Central Government acted without application of its own mind, is begging the question that the executive hierarchy in the Ministry of Health and Family Welfare could override the recommendations of the highly specialized Apex Body consisting of Experts in medicine, Pharmacology and Drug Control. 14. The last but not the least submission made by learned counsel for the petitioners was that in any event, the principles of natural justice have been violated as the petitioners have not been heard before such a ban was put on Item No 41. We have already stated earlier that the Drugs Industry was represented by some of the foremost if not the foremost in the field of Drugs and Pharmacology by M/S Merind, M/S Hoechst and East India Pharmaceuticals Having heard them in the matter and after discussing with the Industry represented by them, it is not a valid argument that each and every Druggist or Pharmacologist engaged in the business of either manufacturing or dealing in the matter, must have been consulted before such a ban was put. It is well settled that the principles of natural justice cannot be contained in a straight-jacket rigid formula.
It is well settled that the principles of natural justice cannot be contained in a straight-jacket rigid formula. That the Druggists and Pharmacologists engaged in the business were heard in the matter and after their participation in the deliberations, the conclusion was reached by the Drugs Control Board which formed the basis of the Govt. Notifications, should be sufficient to fulfill the requirements of natural justice. It was not necessary for each and every Druggist and Pharmacologist to be heard in matters of such policy decisions. 15. Learned counsel for the petitioners sought to invite our attention to the Encyclopedia of Chemicals, Drugs and Biological for the purpose of bringing home the fact that the opinion and/or recommendations of the High Power Technical and Professional Body was not correct We are afraid the submission cannot be accepted as it has already been held earlier that we cannot sit in judgment for the comments and recommendations of such highly technical and professional experts in the relevant fields. Reliance upon a Single Judge decision of the Bombay High Court in case of Unichem Laboratories Ltd. Bombay and another v. Union of India AIR 1988 Bom 134 , is of no avail to the petitioners on the facts and in the circumstances as obtaining in the instant case The Bombay decision aforementioned must be caged, cabined and confined to the facts of that particular case. 16. No other point was raised. 17. For the aforesaid reasons, we do not find any merit in this petition which is accordingly dismissed, but on the facts and in the circumstances of the case, without any costs.