The Union Ministry of Health and Family Welfare has proposed extending restrictions on prescription medicine advertisements to licensed retailers, wholesalers and distributors, making prior Central Government approval mandatory for promotions involving specified categories of drugs.
The draft amendment to the Drugs Rules, 1945, was notified through Gazette Notification GSR 861(E) on September 28, 2026, following consultations with the Drugs Technical Advisory Board (DTAB).
Under the proposed changes, advertisements for medicines listed under Schedules H, H1 and X would require prior government approval before publication or circulation by any entity licensed to sell or distribute them.
Existing rules prohibit pharmaceutical manufacturers from advertising medicines covered by these schedules without prior approval. However, the restrictions do not explicitly cover licensed retailers, wholesalers and other distributors.
To address this gap, the ministry has proposed adding sub-rule (22) to Rule 65 of the Drugs Rules, 1945. The provision would apply to entities licensed to sell, stock, exhibit or offer the specified medicines for sale, as well as those involved in their distribution.
The proposed amendment aims to strengthen oversight across the pharmaceutical supply chain, prevent unauthorised promotion of prescription medicines and reduce the risks associated with inappropriate self-medication. The categories include medicines requiring medical supervision, such as certain antibiotics and psychotropic drugs.
The move follows recommendations made at the DTAB’s 93rd meeting on February 16, 2026, when the board examined the need to regulate advertisements issued by licensed sellers and distributors.
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 Central Government will examine the submissions before deciding whether to finalise the amendment.
