1. Export and manufacture of fixed dose combinations of Analgin — Modification of export permissions — Continuation of manufacture ban. (Para 1 , 2 )
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1997 Supreme(SC) 848
SUPREME COURT OF INDIA
J.S.Verma, CJI., B.N.Kirpal, S.P.Kurdukar, JJ.
Drug Action Forum
Versus
Union Of India
Case No., 698 of 1993, 422 of 1995
Date of Decision, 5/7/97
The court permitted the export of existing stocks of banned fixed-dose drug combinations across all brand names while upholding the ban on their further manufacture, rejecting requests for postponement of the ban.
Headnote:(A) Drug Regulation - Export and Manufacture of Fixed Dose Combinations - Permission granted for export of fixed dose combinations of a specific drug manufactured in India, including all existing stock, subject to the terms and conditions previously specified for stock manufactured prior to a certain date - Earlier order modified to this extent. (Para 1)
(B) Ban on Manufacture - Request for postponement of ban based on recommendations - Court not satisfied that any relaxation should be granted - Ban on manufacture of fixed dose combinations of the drug to continue. (Para 2)
Facts of the case:
A ban had been imposed on the manufacture of fixed dose combinations of a specific drug. A previous court order had granted permission for the export of certain stocks of these combinations. The court was requested to modify the export permission to cover all brand names and existing stocks and to postpone the date of the manufacturing ban based on recommendations from a specialized group.
Findings of Court:
The court modified the previous order to permit the export of fixed dose combinations of the drug under any brand name, including all existing stock, under the same terms and conditions as the previous order. However, the court found no justification to relax or postpone the ban on the manufacture of these combinations.
Issues: Whether the permission for export of fixed dose combinations of a specific drug should be extended to all brand names and existing stock, and whether the ban on their manufacture should be postponed based on external recommendations.
Ratio Decidendi: The court held that while the export of existing stocks and various brand names could be permitted under existing terms, the recommendations provided were insufficient to warrant a relaxation or postponement of the ban on the manufacture of the drug combinations.
Result: Petitions disposed of.
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Table of Contents
2. Submission that the ban on manufacture of fixed dose combinations of Analgin should be postponed in light of Core Group recommendations. (Para 2 )
3. The court found that recommendations from a Core Group were insufficient to justify the postponement of the ban on the manufacture of fixed dose combinations. (Para 2 )
4. A judicial ban on the manufacture of drug combinations remains in effect unless the court is satisfied that relaxation is warranted based on the evidence provided. (Para 2 )
5. Export of existing stocks permitted; ban on manufacture upheld; petitions disposed of. (Para 1 , 2 , 3 )
6. Can the court permit the export of drug combinations that are banned from manufacture?
Yes, the court may modify previous orders to permit the export of existing stocks of banned fixed dose combinations under specific terms and conditions. (Para 1 )
7. Does a recommendation from a Core Group automatically necessitate the postponement of a judicial ban on drug manufacture?
No, the court must be satisfied that the recommendations justify such a relaxation; otherwise, the ban on manufacture continues. (Para 2 )
(1) HAVING heard Mr F.S. Nariman, Mr N.N. Goswamy, Senior Advocates and Mr Prashant Kumar, Advocate, we modify the earlier order dated 24/2/199797( Drug Action Forum v. Union of India 1997 9 SCC 609 The permission granted by the order dated 24/2/1997 for export of the fixed dose combinations of Analgin known by any brand name manufactured by any of the companies in India and the entire existing stock with them as of today is permitted in the same manner and subject to the same terms and conditions as indicated in the order dated 24/2/1997 with regard to the stock of the drugs manufactured prior to 17/12/1997. The earlier order dated 24/2/1997 stands modified to this extent only.
(2) WE have also considered the submission of some of the learned counsel that the date of the imposition of the ban on manufacture of the fixed dose combinations of Analgin known by any brand name, be postponed in view of certain observations made in Core Group recommendations. We are not satisfied that any relaxation should be granted in this respect. The earlier order relating to imposition of ban on manufacture of fixed dose combinations of Analgin known by any brand name is, therefore, to continue.
(3) ALL the INDIAN ADMINISTRATIVE SERVICE are disposed of in terms of the above order.
(4) LIST the petitions on 20/8/1997.
