The Union Health Ministry has proposed stricter curbs on the advertising of prescription-only medicines, seeking to extend the existing restrictions beyond pharmaceutical manufacturers to pharmacies, wholesalers and distributors. Under the draft rules, notified through gazette notification G.S.R. 861(E) on September 28, 2026, advertisements for medicines listed under Schedules H, H1 and X of the Drugs Rules, 1945 would need prior approval from the Central Government before they can be promoted by these entities.

The proposal was framed after consultations with the Drugs Technical Advisory Board, whose 93rd meeting in February this year recommended the change. At present, the rules prohibit pharmaceutical companies from advertising drugs covered by these schedules without the Centre’s prior sanction. But the restriction does not explicitly cover the entities that sell and distribute the medicines – a regulatory gap the ministry now wants to close.

The regulatory gap

To plug the loophole, the ministry has proposed inserting a new sub-rule (22) under Rule 65 of the Drugs Rules, 1945. The provision would extend the advertisement restriction to all holders of licences to sell, stock, exhibit, offer for sale or distribute drugs – including retail medical stores and wholesale drug dealers. The proposed wording is simple: no advertisement of drugs specified in Schedule H, Schedule H1 or Schedule X shall be made without the previous sanction of the Central Government. Schedule H covers medicines dispensed only against a valid prescription, numbering more than 500 commonly used drugs; Schedule H1 carries additional controls and record-keeping requirements for certain antibiotics and other specified medicines; and Schedule X applies stricter controls on drugs with misuse and dependence potential.

Why the curbs matter

The ministry says the amendment is meant to strengthen oversight across the pharmaceutical supply chain, discourage the unauthorised promotion of prescription medicines and reduce the risks of inappropriate self-medication. Officials believe the change will reinforce safeguards around medicines that require professional medical supervision – including several antibiotics and psychotropic substances – by ensuring they are not marketed directly to consumers without adequate checks. The draft is open for objections and suggestions from stakeholders and the public for 30 days from the date the gazette copies are made available; inputs received within that window will be considered before the amendment is finalised.