Health Ministry proposes extending advertisement curbs on Schedule H, H1 and X drugs to retailers and wholesalers
On 9 October 2026, the Union Health Ministry highlighted a draft amendment to the Drugs Rules, 1945 (Gazette G.S.R. 861(E) dated 28 September 2026) to require prior Central Government sanction for advertisements of Schedule H, H1 and X medicines by retail and wholesale licence holders.
Summary
The Ministry of Health and Family Welfare proposed inserting sub-rule (22) under Rule 65 of the Drugs Rules, 1945 so that holders of licences to sell, stock, exhibit or distribute drugs—including retailers and wholesalers—cannot advertise Schedule H, H1 or X medicines without previous Central Government sanction. Manufacturers already faced this restriction; the draft closes the gap for the distribution chain. The proposal follows the 93rd DTAB meeting (16 February 2026). Stakeholders were invited to submit objections/suggestions within 30 days of the Gazette copies being made available.
Key facts
- Instrument
- Draft amendment to Drugs Rules, 1945 — G.S.R. 861(E) (28 Sep 2026)
- Proposed insertion
- Sub-rule (22) under Rule 65
- Schedules covered
- Schedule H, H1 and X
- Newly covered entities
- Retail/wholesale sale and distribution licence holders
- Advisory body
- 93rd DTAB meeting (16 February 2026)
Practice MCQs 2 questions
The October 2026 Health Ministry draft seeks to extend prior-sanction advertising curbs to which drug schedules for retailers and wholesalers?
Show answer
Correct answer: A — Schedule H, H1 and X
Under which rule of the Drugs Rules, 1945 does the October 2026 draft propose inserting a new sub-rule for retailer/wholesaler drug advertisements?
Show answer
Correct answer: B — Rule 65