India's draft Rule 65(22) would curb prescription drug advertising by drug sellers
Short answer
A draft amendment to India's Drugs Rules, G.S.R. 861(E) of 28 September 2026, would bar retail and wholesale drug licence holders, including online pharmacies and distributors, from advertising Schedule H, H1 or X medicines without prior Central Government sanction. It is a draft open for comment, not yet law, and would shape how Indian suppliers present prescription medicines online.
Key takeaways
- Draft G.S.R. 861(E) of 28 September 2026 would add sub-rule (22) to Rule 65 of India's Drugs Rules 1945.
- It would bar advertising of Schedule H, H1 and X drugs by sale and distribution licence holders without the previous sanction of the Central Government.
- Manufacturers already face a similar restriction, so the draft extends it to retailers, wholesalers, distributors and online pharmacies.
- A law firm analysis says routine product listings and factual information are unlikely to count as advertising, although the draft does not address digital advertising directly.
- The draft was open for comments for 30 days and had not been finalised when the sources for this update were published.
What changed
India's Ministry of Health and Family Welfare published draft rules, notification G.S.R. 861(E) dated 28 September 2026, to amend the Drugs Rules 1945 after consulting the Drugs Technical Advisory Board. As reported by Medical Dialogues, the draft would insert a new sub-rule (22) in Rule 65. It says that no advertisement of drugs in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.
Rule 65 sets the conditions for licences to sell, stock, exhibit or offer for sale, or distribute drugs. The draft would therefore reach retail and wholesale licence holders. Nishith Desai Associates lists retail pharmacies, wholesalers, pharmacy chains, online pharmacies, stockists and distributors, and says each would need its own sanction even where the manufacturer already has one. Manufacturers are already subject to a similar condition. Under Rule 66, a breach could lead to suspension or cancellation of the licence.
Comments were invited within 30 days of the Gazette copies being made available, addressed to the Under Secretary (Drugs) at the Ministry. The Gazette text itself was not read for this update, and these details come from the reports above.
This is a draft. It is not yet law and may change or be dropped.
Who it affects
- Indian wholesalers, distributors and exporters that hold sale licences under Rule 65 and publish product information online.
- Indian online pharmacies and retail chains.
- Indirectly, overseas hospitals, importers and NGOs that look for Indian supply information on supplier websites.
What it means for buyers
The draft does not change export approvals, documents or which medicines can be supplied. It is about promotion. If adopted, Indian suppliers holding sale licences would likely keep public pages for prescription medicines factual: availability, regulatory status, documents and access routes, without promotional claims.
Nishith Desai Associates says routine prescription drug listings and factual information are unlikely to be treated as advertisements. It also notes that the draft does not set the procedure, documents or timelines for obtaining sanction, and does not specifically address digital advertising. Until final rules appear, suppliers may take a cautious line online.
The proposal follows broader scrutiny of drug promotion in India, including a CDSCO advisory of 10 March 2026 on direct and surrogate advertising of GLP-1 receptor agonists, described in the same law firm analysis.
What to do now
- Expect Indian supplier pages to describe availability and regulatory status rather than promote prescription medicines.
- Ask for product information, certificates and regulatory documents through a formal enquiry rather than relying on public pages.
- Check later whether the Ministry publishes final rules in the Gazette, and how they define advertising.
For the export rules that do apply to Indian suppliers today, see Indian export rules buyers should know.
This page explains how regulatory routes work. It is not legal or medical advice. Confirm current requirements with the regulator or a local agent before goods ship.
Questions and answers
Is the advertising restriction in force?
No. G.S.R. 861(E) is a draft published for comments. It becomes law only if the Ministry of Health and Family Welfare publishes final rules in the Gazette, and no final notification was found when this update was written.
Would it stop Indian suppliers from listing prescription medicines?
A law firm analysis says routine listings and factual information are unlikely to count as advertising. The draft does not define the line for online content, so suppliers may keep listings factual and avoid promotional claims.
References
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