India plans prior sanction for prescription drug ads by drug sellers

India’s Ministry of Health and Family Welfare has published a draft rule that would require the central government’s prior sanction before any drug listed in Schedule H, Schedule H1 or Schedule X of the Drugs Rules, 1945 is advertised. Draft notification G.S.R. 861(E), dated 28 September 2026 and printed in the Gazette of India Extraordinary dated 5 October 2026, proposes inserting a new sub-rule (22) into Rule 65 of the Drugs Rules.

The advertising restriction on these prescription medicines currently applies only to manufacturers, and the amendment would extend it to holders of licences to sell, stock, exhibit, offer for sale or distribute drugs, including retailers, wholesalers and distributors, according to Medical Dialogues, which reported the draft on 9 October 2026. The draft text itself does not list categories of licence holder and states no exceptions.

What the draft says

The notice is issued under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB). It is signed by Pushpendra Rajput, Joint Secretary in the Department of Health and Family Welfare. Medical Dialogues reported that the board considered the proposal at its 93rd meeting on 16 February 2026.

The new sub-rule would take effect on the date of its final publication in the Official Gazette. Objections and suggestions may be sent within 30 days from the date on which copies of the Gazette containing the draft are made available to the public, addressed to the Under Secretary (Drugs) at the ministry in New Delhi. The notice does not give a fixed closing date, and it does not set out how a seller would apply for sanction or how long a decision would take.

Which medicines are affected

Schedule H covers prescription medicines that may be sold by retail only on the prescription of a registered medical practitioner, according to Medical Dialogues. Schedule H1 covers certain antibiotics, anti-tuberculosis medicines and drugs liable to misuse, with cefixime and alprazolam cited as examples, and requires sellers to keep a separate supply register for three years. Schedule X covers tightly controlled medicines such as amphetamine, methylphenidate and certain barbiturates, which require specific sale licences, duplicate prescriptions and secure storage.

The draft states no exceptions, so as written it would not distinguish between advertising aimed at consumers and material aimed at doctors or other trade buyers. It gives no date for final publication and does not say what would happen to advertising already running when the rule takes effect.

Our reading

Analysis by The Healthcare Daily.

• Pharmacy chains, wholesalers and distributors that advertise Schedule H, H1 or X medicines would need central sanction before doing so if the rule is finalised as drafted, so marketing and compliance teams should review existing campaigns that name prescription products.
• The amendment would align the obligation on sellers with the one already placed on manufacturers, closing what Medical Dialogues described as a regulatory gap through which restricted products could be promoted further down the supply chain.
• Because the draft sets no sanction procedure or decision timeline, trade bodies for chemists and distributors have a 30-day window from public release of the Gazette to seek clarity on scope, including how the rule would treat price lists, availability notices and online listings.