Centre proposes curbs on drug advertisements by retail, wholesale licence holders
The Health Ministry has proposed extending prior approval norms for prescription drug advertisements to retailers, wholesalers and distributors. The draft amendment seeks to close a regulatory gap and curb unauthorised promotion that could encourage self-medication.
- Oct 09, 2026,
- Updated Oct 09, 2026, 1:43 PM IST
- Draft amendment seeks prior approval before circulating ads for scheduled medicines
- Proposal covers Schedule H, H1 and X drugs needing medical supervision
- New sub-rule under Rule 65 targets sellers, stockists and distributors
The Union Ministry of Health and Family Welfare has proposed stricter rules governing advertisements for prescription medicines, seeking to extend existing restrictions to retailers, wholesalers and other licensed drug distributors.
The draft amendment to the Drugs Rules, 1945, would require prior approval from the Central Government before advertisements for medicines listed under Schedule H, Schedule H1 and Schedule X can be published or circulated by entities holding licences to sell or distribute them.
The proposal was notified through Gazette Notification GSR 861(E) on September 28, 2026, following consultations with the Drugs Technical Advisory Board (DTAB).
Under the existing rules, pharmaceutical manufacturers cannot advertise medicines covered by these schedules without prior Central Government approval. However, the restrictions do not explicitly extend to licence holders involved in the retail and wholesale sale and distribution of such drugs.
To address this gap, the ministry has proposed inserting sub-rule (22) under Rule 65 of the Drugs Rules, 1945. The provision would cover entities licensed to sell, stock, exhibit or offer medicines for sale, as well as those involved in their distribution.
If finalised, the amendment would prohibit advertisements for Schedule H, Schedule H1 and Schedule X medicines without prior government approval, regardless of whether the promotion originates from a manufacturer or a licensed seller or distributor.
The ministry aims to strengthen oversight across the pharmaceutical supply chain, curb unauthorised promotion of prescription medicines and reduce the risks associated with inappropriate self-medication. The proposed restrictions would cover medicines requiring medical supervision, including certain antibiotics and psychotropic drugs.
The move follows recommendations made at the 93rd meeting of the DTAB on February 16, 2026. The board examined the need for provisions regulating advertisements issued by holders of licences for the sale and distribution of medicines.
The ministry has invited objections and suggestions from stakeholders and members of the public within 30 days of the draft rules being made available through the Gazette. The submissions will be examined by the Central Government before the proposed amendment is finalised.
