Summary
In challenges to notifications banning fixed-dose drug combinations, the Court held that prior consultation with the Drugs Technical Advisory Board was not mandatory under section 26A. On these particular facts it nevertheless directed a reasoned expert reconsideration, with distinct treatment of pre-1988 drugs, continued status quo, and separate disposal of transferred Madras cases.
Issues
- Whether section 26A required prior consultation with the statutory technical board.
- What reconsideration and interim arrangements should govern these challenged notifications.
Provisions considered
- Sections 5 and 26A, Drugs and Cosmetics Act, 1940Unlike provisions expressly requiring board consultation, section 26A conferred an additional power based on relevant material, the prescribed drug-related grounds and public interest. (¶¶ 14–25, 30)
Held
- Prior DTAB consultation was not a statutory precondition. Parliament deliberately omitted that requirement while expressly providing it elsewhere; the Government could rely on other relevant expert material. Advice might be desirable without being mandatory. (¶¶ 15–23, 30)
- Satisfaction required relevant material establishing a statutory ground and public-interest necessity or expediency. Action based on irrelevant or no material remained vulnerable to judicial review. The Court did not decide whether the power was legislative or whether natural justice was generally excluded. (¶¶ 24–25, 31)
- For these cases only, DTAB or its subcommittee was to hear the manufacturers and All India Drugs Action Network, give reasons for the statutory ground and appropriate response, and explain why prohibition rather than regulation or restriction was needed. A consolidated report was sought within six months, followed by a fresh governmental decision. (¶ 32–36)
- Notifications concerning the fifteen identified pre-21 September 1988 drugs were set aside, without preventing a fresh inquiry. The seventeen cases claiming DCG(I) approval were not excluded from expert reconsideration. Existing status quo continued, including for the five additional combinations, until fresh notifications. (¶ 37–39)
- The transferred Madras cases were disposed of in accordance with the already completed DTAB expert review, whose report the Court accepted. (¶ 40)
Result
Delhi High Court’s mandatory-consultation ruling set aside; appeals disposed of with case-specific expert reconsideration and status-quo directions. Fifteen pre-1988 bans set aside subject to fresh inquiry; Madras transferred cases disposed of under their accepted expert report.