The Union Ministry of Health and Family Welfare has proposed stricter regulations on the advertising of prescription medicines by extending existing restrictions to retailers, wholesalers and distributors.
The proposed amendment to the Drugs Rules, 1945, seeks to make prior approval of the Central Government mandatory for advertisements relating to medicines listed under Schedule H, Schedule H1 and Schedule X.
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 framework, pharmaceutical manufacturers are prohibited from advertising medicines covered under these schedules without prior approval from the Central Government. However, the provisions do not explicitly extend the same restriction to entities involved in the retail and wholesale sale and distribution of these drugs.
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 restrictions to licence holders authorised to sell, stock, exhibit or offer medicines for sale, or distribute them.
The proposed measure aims to strengthen regulatory oversight across the pharmaceutical supply chain, curb unauthorised promotion of prescription medicines and reduce the risks associated with inappropriate self-medication.
The restrictions would cover medicines requiring medical supervision, including certain antibiotics, psychotropic medicines and other prescription-only drugs.
The proposal follows recommendations made at the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, 2026, which examined the need for provisions regulating 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 the Gazette notification containing the draft rules is made available to the public.
The submissions received within the prescribed period will be considered by the Central Government before the amendment is finalised.
The draft notification is available on the official Gazette website.
