Centre Tightens Proposed Curbs on Drug Advertising

GG News Bureau
New Delhi, 9th Oct: The Union Health Ministry has proposed tighter controls on the advertising of prescription medicines, seeking to bring retail chemists, wholesalers and distributors under restrictions that currently apply to pharmaceutical manufacturers.

The proposed amendment to the Drugs Rules, 1945, aims to curb unauthorised promotion of prescription-only medicines and reduce the risks associated with inappropriate self-medication. The draft was notified through Gazette Notification G.S.R. 861(E), dated September 28, 2026, following consultations with the Drugs Technical Advisory Board (DTAB).

Under the existing framework, manufacturers cannot advertise medicines listed under Schedule H, Schedule H1 and Schedule X without prior sanction from the Central Government. However, the rules do not explicitly extend the same requirement to businesses involved in the retail and wholesale sale and distribution of these medicines.

To address this gap, the Ministry has proposed inserting sub-rule (22) under Rule 65 of the Drugs Rules, 1945. The provision would extend the advertising restriction to licence holders authorised to sell, stock, exhibit, offer for sale or distribute drugs, including retailers and wholesalers.

Under the proposed rule, advertisements for medicines covered by Schedule H, H1 and X would require prior approval from the Central Government.

The move is intended to strengthen oversight across the pharmaceutical supply chain. These schedules cover prescription medicines that require appropriate medical supervision, including certain antibiotics, psychotropic medicines and other drugs for which inappropriate use can pose health risks.

The proposal follows recommendations made at the 93rd meeting of the Drugs Technical Advisory Board on February 16, 2026. The board considered the need for specific provisions to regulate advertisements issued by drug sale and distribution licence holders.

Public Feedback Invited
The Ministry has invited objections and suggestions from stakeholders and members of the public on the draft amendment. Submissions must be made within 30 days from the date the Gazette containing the draft rules is made available to the public.

The Central Government will examine the submissions received within the prescribed period before deciding whether to finalise the amendment. The restrictions remain a proposal and should not be treated as final rules at this stage.