SYSTOPIC LABORATORIES PRIVATE LIMITED IND SWIFT LIMITED UNIMARCH PHARMA PRIVATE LIMITED Vs. PREM GUPTA:DRUGS CONTROLLER INDIA :DRUGS CONTROLLER INDIA :DRUGS CONTROLLER INDIA :DRUGS CONTROLLER 1 :DRUGS CONTROLLER 1 :S S GOTHASKAR:GHANSHYAM SHARMA AND OTHE

JUDGEMENT

(1.) These cases raise common questions involving challenge to the validity of the notification dated November 3, 1988 issued by the Government of India, whereby the earlier notification dated July 23, 1983 was amended and item No. 14 of the drugs specified in the Table in the said notification was substituted so as to prohibit completely the manufacture and sale of fixed dose combination of steroids with other drugs for internal use. The said notification has been issued in exercise of the power conferred by S. 26A of the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'the Act'). In the said notification, it has been stated that the Central Government is now satisfied that long 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. S.L.P.(C) No. 1538 of 1991 filed against the said decision was also dismissed by this Court on January 6, 1992 with the following observations-

(3.) Following the aforesaid decision of the Madras High Court in Micro Lab's case (supra), a Division Bench of the High Court of Punjab and Haryana, by judgment dated June 3, 1992, dismissed a number of writ petitions wherein the validity of the notification dated November 3, 1988 had been challenged. Civil Appeals (C) Nos. 2791-96 of 1992 and SLP (C) Nos. 9972 of 1992 and 10745 of 1992 are directed against the said decision of the High Court of Punjab and Haryana. Transferred Cases (C) Nos. 13 and 14 of 1992 relate to writ petition No. 1701 of 1984 (Fulford India Limited v. Dr. S. S. Gothoskar and Writ Petition No. 1746 of 1984.) Wyeth Laboratories Ltd. v. Dr. S. S. Gothoskar) which were originally filed in the Bombay High Court. The appellants in the appeals (who would be referred to as the petitioners for the sake of convenience) as well as the petitioners in Special Leave Petitions and the Transferred Cases have been manufacturing fixed dose combinations of corticosteroids with anti-histamines and corticosteroids with broncho-dilators under different names. The petitioner in Writ Petition No. 364 of 1992, which has been filed under Art. 32 of the Constitution holds a licence granted by Director, Drugs Control Administration of the Government of Andhra Pradesh for the manufacture and sale of medicines and drugs. The said petitioner is not manufacturing the prohibited drugs but has submitted an application for permission to manufacture the said drugs.