Prescription drug advertising: draft curbs on sellers and distributors
Why in the news
On 9 October 2026 the Ministry of Health and Family Welfare said it has proposed tighter control over advertising of prescription-only medicines by amending the Drugs Rules, 1945.
Key facts
- Draft notification: GSR 861(E), dated 28 September 2026.
- Change proposed: a new sub-rule (22) under Rule 65 of the Drugs Rules, 1945.
- Drugs covered: those in Schedule H, Schedule H1 and Schedule X.
- Who is covered: licence holders who sell, stock, display, offer for sale or distribute these drugs, including retailers, wholesalers and distributors.
- Rule: no advertisement of such drugs without prior approval of the Central Government.
- Consultation: objections and suggestions invited within 30 days of the draft being made public.
Current versus proposed position
| Entity | Current rules | Draft rule |
|---|---|---|
| Manufacturers | Need prior Central approval | Need prior Central approval |
| Retailers, wholesalers, distributors | Not clearly covered | Need prior Central approval |
About the proposal
The draft followed the 93rd meeting of the Drugs Technical Advisory Board (DTAB), held on 16 February 2026, which recommended provisions to control advertising by drug sale and distribution licensees. The stated aims are stronger oversight of the supply chain, discouraging unauthorised promotion of prescription drugs such as certain antibiotics and psychiatric medicines, and reducing the risks of self-medication.
Exam angle
- Schedule H, H1 and X list prescription-only drugs under the Drugs Rules, 1945.
- Manufacturers already need Central approval; the draft extends this to the supply chain.
- Note the identifiers: GSR 861(E), Rule 65(22), 30-day comment window.