Govt plans tighter rules for prescription drug ads: what will change?

The Union Health Ministry has proposed tighter restrictions on the advertising of prescription medicines, seeking to bring drug retailers, wholesalers and distributors under the same advertising framework that applies to pharmaceutical manufacturers.

Under the proposed amendment to the Drugs Rules, 1945, advertisements for medicines listed under Schedule H, Schedule H1 and Schedule X would require prior approval from the Central government.

The draft seeks to insert a new sub-rule under Rule 65. It states, “No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.”

The proposed rule would apply to holders of licences to sell, stock, exhibit or offer drugs for sale, as well as those involved in their distribution. This would extend the advertising restriction to retailers, wholesalers and distributors of these medicines.

At present, manufacturers of drugs covered under Schedule H, H1 and X cannot advertise them without prior Central government sanction. The government said the corresponding provision does not explicitly cover entities involved in the retail and wholesale sale and distribution of these medicines.

READ THIS: Cancer drug prices may fall up to 70% as govt caps trade margins

“The measure is also intended to reduce the risks associated with inappropriate self-medication and reinforce safeguards around medicines that require medical supervision, including certain antibiotics, psychotropic medicines and other prescription-only drugs,” the government said.

The proposal follows recommendations of the Drugs Technical Advisory Board (DTAB) at its 93rd meeting held on February 16, 2026. The board considered the need for provisions governing advertisements by drug sale and distribution licence holders.

For pharmacies, wholesalers and distributors, the change could mean an additional compliance requirement for promotional activity involving medicines covered under the three schedules.

The proposal is still at the draft stage. The Health Ministry has invited objections and suggestions from stakeholders and members of the public within 30 days from the date the Gazette containing the draft rules was made available. The government will consider the submissions before deciding whether to finalise the amendment.

If finalised, the rules will come into force from the date of their publication in the Official Gazette.