The Union Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945, aiming to extend regulatory oversight over advertisements of prescription-only medicines to entities engaged in retail and wholesale sale and distribution.
On October 9, 2026, the Union Ministry of Health and Family Welfare announced a proposed amendment to the Drugs Rules, 1945, with the intention of strengthening regulation over advertisements relating to prescription-only medicines. The draft amendment 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 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 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 licences to sell, stock, exhibit or offer for sale, or distribute drugs, including retail and wholesale drug licence 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 proposal follows the recommendations of the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, 2026, which considered the need for appropriate provisions governing advertisements by drug sale and distribution licence 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. The link to the Official Gazette is provided below for reference.
Source:
Press Information Bureau
