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S. C. AGRAWAL, M. N. VENKATACHALIAH
Systopic Laboratories Private LTD. : Ind Swift LTD. : Unimarch Pharma Private: Laurel Pharmaceuticals Private: J. B. Enterprises: J. B. Enterprises: Fulford India LTD. : Besto Chem Formulation: Franklin Laboratories Private LTD. : Chinnikem Pharma – Appellant
Versus
Prem Gupta: Drugs Controller India: Drugs Controller India: Drugs Controller India: Drugs Controller: Drugs Controller: S. S. Gothaskar: Ghanshyam Sharma: Drugs Controller: Union Of India – Respondent
Judgment
S. C. AGRAWAL, J.:- 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-
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