The Union Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945, to strengthen regulation of advertisements relating to prescription-only medicines. The proposed amendment seeks to extend the existing requirement of prior central government sanction for advertising drugs specified under Schedule H, Schedule H1 and Schedule X to entities holding licenses for the sale and distribution of drugs.

The draft amendment has been 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 regulatory framework, pharmaceutical manufacturers are prohibited from advertising drugs covered under Schedule H, Schedule H1 and Schedule X without prior sanction of the central government. However, corresponding provisions have not explicitly covered entities engaged in the retail and wholesale sale and distribution of these medicines.

To address this regulatory gap, the ministry has proposed the insertion of sub-rule (22) under Rule 65 of the Drugs Rules, 1945, extending the advertisement restriction to holders of licenses to sell, stock, exhibit or offer for sale, or distribute drugs, including retail and wholesale drug license holders.

Under the proposed provision, no advertisement of drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the central government.

The proposed amendment is intended to strengthen regulatory oversight across the pharmaceutical supply chain, discourage unauthorised promotion of prescription medicines and reduce risks associated with inappropriate self-medication.

The measure is expected to reinforce safeguards relating to medicines that require appropriate medical supervision, including certain antibiotics, psychotropic medicines and other prescription-only drugs.

The proposal follows the recommendations of the 93rd meeting of DTAB, held on February 16, 2026, which considered the need for appropriate provisions governing advertisements by drug sale and distribution license holders.

The ministry has invited objections and suggestions from stakeholders and members of the public within 30 days from the date on which copies of the Gazette containing the draft rules are made available to the public. Submissions received within the prescribed period will be considered by the central government before finalisation of the amendment.