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TMI Blog1993 (9) TMI 369X X X X Extracts X X X X X X X X Extracts X X X X ..... g term use of steroids in fixed dose combinations for treatment of asthma is likely to involve risk to human beings and such formulations do not have therapeutic justification and further that it is necessary and expedient in public interest to prohibit the manufacture and sale of the said drugs. 2. A number of manufacturers, including the appellants in Civil Appeals Nos. 2791-96 of 1992 and the petitioners in SLP(C) Nos. 9972 and 10745 of 1992 and Transferred Cases (C) Nos. 13-14 of 1992, filed writ petitions in various High Courts to challenge the validity of the said notification. One of these writ petitions (No. 364 of 1993), filed in the Madras High Court by Micro Labs (P) Ltd., was dismissed by a Division Bench of the said High Court by judgment dated June 18, 1991. SLP(C) No. 1538 of 1991 filed against the said decision was also dismissed by this Court on January 6, 1992 with the following observations- The special leave petition is dismissed. The petitioner, however, will be permitted to make a fresh application for permitting manufacture and sale of drugs in question which will be considered by the Technical Board which will include one or more practicing doctors spe ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... le Governments and the Board on any matter tending to secure uniformity throughout India in the administration of the Act. Section 26A, which was introduced in the Act by Drugs Amendment Act, 1982 (Act No. 68 of 1982), provides as under - 26A. Without prejudice to any other provisions contained in this Chapter, it the Central Government is satisfied, that the use of any drug or cosmetic is likely to involve any risk to human being or animals or that any drug does not have therapeutic value claimed or purported to be claimed for it or contains ingredients and in such quantity for which there is no therapeutic justification and that in the public interest it is necessary or expedient so to do, then the Government may, by notification in the official Gazette, prohibit the manufacture, sale or distribution of such drug or cosmetic. 5. In 1979, the DCC had set up an Experts Committee as a Sub-Committee of the DCC for screening the formulations of drugs prevalent in the Indian market from the point of view of therapeutic rationale in order to weed out irrational/harmful combination of drugs. The Sub-Committee examined a number of fixed dose combinations of drugs which did not appea ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... including Item 14, were fixed dose combinations of certain drugs. Item 14 in the said notification was- 14. Fixed dose combination of Steroids for internal use except combination of Steroids with other drugs for the treatment of Asthma. 9. Similar exception had been made in item No. 15 relating to fixed dose combinations of chloramphenicol for fixed dose combination of Chloramphenicol and Streptomycin. 10. It appears that there was criticism in various form of the exemption granted for fixed dose combinations of Steroids for treatment of asthma and medical critics opined that there is hardly a clinical situation where a fixed dose combination of corticosteroids with drugs like branch-dilators are required. Taking note of the criticism the Sub-Committee of the DCC at the meeting held on January 15, 1987 felt it necessary to review again the fixed dose combination of corticosteroids and it was decided that the manufacturers of such drugs be asked to establish published evidence of rationality for continued marketing of such combinations. It was also decided that the experts should also be requested to participate in the next meeting. At the next meeting held on June 3, 1987 ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... sitized mast cells in very high concentration near the target cells and antihistaminics cannot block such effect quantitatively. Besides many more chemical mediators are released in scnsitized target cells not antagonised by antihistaminics. There is a lack of published evidence to prove the higher efficacy of such combination over Corticosteroid alone. Such combinations should not be allowed. 11. The Sub-Committee at its meeting held on January 15-16, 1988, noticed that the experts have opined that little will be achieved by conducting trial on these categories and have reiterated their earlier stand of recommending withdrawal of fixed dose combination of steroids with branch-dilators for systematic use. The Sub-Committee has also recorded that the manufacturers of these formulations were asked through IDMA and OPP1 to furnish evidence justifying their continued marketing of fixed dose combinations of corticosteroids with other drugs for internal use and the literature and any other information furnished by the manufacturers were given an opportunity for pleading their case in person with the experts and that after going through the information and literature furnished by the m ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... dated November 3, 1988, manufacture and sale of fixed dose combination of corticostcroids with any other drug for internal use have been completely prohibited and the earlier exemption of such fixed dose combinations for treatment of asthma has been withdrawn. 16. In this context it may be mentioned that in writ petition No. 3554 of 1988 filed by M/s. Roussel Pharmaceuticals pending before the Bombay High Court, the following observations were made by the High Court in an order dated February 21, 1989 - the Government, even at this stage, may apply its mind afresh and hear all the persons concerned on this question and then take appropriate decision. 17. In view of the said observations, the matter of prohibition of fixed dose combination of steroids with Other drugs for internal use was considered afresh by a Committee of Experts. Five manufacturers, including the two petitioners in T.C. Nos. 13 and 14 of 1992 and M/s. Roussel Pharmaceuticals India Ltd. had sent their representatives to put forward their views in person, but apart from M/s. Roussel Pharmaceuticals, none of the other manufacturers presented any scientific paper or any fresh evidence in support of continued ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... It has also been pointed out that fixed dose combinations of corticosteroids and anti-histamine or branch-dilators are being marketed freely in a number of countries such as Germany, Japan, France, Switzerland, Australia etc. It has also been urged that where the patient has to take two different tablets together at the same time, it is always a serious problem to ensure that he takes both of them regularly, and as required that the problem of patient compliance is all the more acute in a country where the level of illiteracy is very high, as in India. Similarly, on behalf of the respondents extracts from mediacal treatises and foreign medical journals have been filed to show that fixed dose combination of corticosteroids and anti-histamines is irrational because anti-histamines have no role to play in asthma management and that in respect of bronchial asthma, the standard treatment is broncho-dilator and in cases of severe chronical asthma where broncho-dilator alone fails to give desired result corticosteroids may be resorted as a therapy but the dosage needs to be regulated carefully. It has been submitted that at no stage fixed dose combinations of corticosteroids with other d ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... erts to consider the views of the affected manufacturers who represented against the proposed withdrawal of certain formulations moving in the market which were held on September 8, 1987, October 16-17, 1987 and January 15-16, 1989 show that among the members were included Dr. O.D.Gulati, Dean, CAM Medical College, Karansad and Dr. J.P.Wali, Assistant Professor of Medicine, AIIMS, New Delhi. Dr. M.Durairaj, Consultant, Cardiologist, Director of Cardiology, Poona Hospital Research center, Pune was also member of the Sub-Committee and had attended the meeting held on January 15-16, 1988. It cannot, therefore, be said that medical experts in clinical medicine were not associated in the Experts Committee for evaluation of the material that was furnished by the manufacturers. 21. It has also been contended that in the meeting of experts held on September 8, 1987, the criteria/guidelines had been indicated for evaluation of each category of formulation and that in the said criteria/guidelines reference is made to comparative clinical trials with the formulation. It has been urged that no such clinical trials of fixed dose combinations of corticostefoids with anti-histamines or bron ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... here is complete prohibition of the manufacture and sale of fixed dose combination of corticosteroids with any other drug for internal use and that such prohibition unreasonably restricts the right of the petitioners to carry on their trade guaranteed under Article 19(1)(g) of the Constitution. The submission is that in order that the said restriction it was necessary for the authorities to consider whether a less drastic course could be adopted, namely, permitting manufacture and sale of such drugs with a warning about its use. Reliance, in this regard, has been placed on the observations of this Court in Mohd. Faruk v. State of Madhya Pradesh and Ors. [1970] 1 SCR 156 . We do not find any merit in this contention. 23. In State of Madras v. V.G. Row 1952 SCR 597, this Court, while emphasising that no abstract standard or general pattern of reasonableness can be laid down as applicable in all cases has indicated the following criteria for examining the reasonableness of the restrictions under Article 19: The nature of the right alleged to have been infringed, the underlying purpose of the restrictions imposed, the extent and urgency of the evil sought to be remedied thereby ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... e combinations of Certain drugs, was prohibited an exception was made in respect of fixed dose combinations of corticosteroids with other drugs for the treatment of asthma. At that time also the DCC had expressed the view that fixed dose combinations of corticosteroids with other drugs were considered harmful for the reason that (i) the adrenal suppression accompanying steroid therapy leads to symptoms and signs of adrenal insufficiency, if the steroid is abruptly withdrawn; and (ii) it is difficult to titrate the dose of a steroid when it is present in fixed dose combinations with other drugs. The DCC had expressed the view that fixed dose combinations of corticosteroids with other drugs are not justifiable as indiscriminate use of corticosteroids can produce serious side effects and in certain clinical conditions where administration of steroids in considered necessary, the drug can be prescribed separately. The Board, however, felt that so far as combination of steroids with other drugs for treatment of asthma are concerned, there was need for examining the matter in further details and getting wider opinion in the matter and therefore, the Board recommended that such combinatio ..... X X X X Extracts X X X X X X X X Extracts X X X X ..... om the harmful consequences. It is, therefore, not possible to hold that the prohibition which has been imposed by the impugned notification on the manufacture and sale of the drug in question imposes an unreasonable restriction so as to be violative of the right guaranteed under Article 19(1)(g) of the Constitution. 27. The learned Additional Solicitor General has pointed out that in view of the observations made by this Court in its order dated January 6,1992 in SLP(C) No. 1588 of 1989, the matter is being considered by the Technical Advisory Board in the light of the fresh material that has been placed before the Board. Having regard to the aforesaid observations in the order dated January 6, 1992, the petitioners as well as other manufacturers who have filed writ petitions in the High Court and whose writ petitions are pending in the High Court can also approach the Board and produce any fresh material in support of their claim for revocation of the ban on manufacture and sale of fixed dose combination of corticesteroids with any drug for internal use for treatment of Asthma. The Board, while considering the matter would take into account the said material which is placed be ..... X X X X Extracts X X X X X X X X Extracts X X X X
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