Prescription Drug Ads: Health Ministry Proposes Tighter Rules for Retailers, Wholesalers
The Union Health Ministry has proposed extending advertising restrictions on prescription medicines to retailers, wholesalers and distributors, bringing them under an approval requirement that already applies to pharmaceutical manufacturers.
Under the draft amendment to the Drugs Rules, 1945, entities licensed to sell and distribute drugs would need prior central government sanction to advertise medicines covered by Schedule H, Schedule H1 and Schedule X.
The proposal seeks to close a regulatory gap: while manufacturers face this restriction, the corresponding provisions do not explicitly cover retail and wholesale sellers and distributors.
WHAT WOULD CHANGE?
The ministry has proposed inserting sub-rule (22) under Rule 65 of the Drugs Rules. It would cover licence holders authorised to sell, stock, exhibit or offer drugs for sale, or distribute them.
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Under the proposed provision, these entities could advertise medicines listed under Schedules H, H1 and X only after obtaining central government sanction.
The draft was notified through Gazette Notification GSR 861(E), dated September 28, 2026, following consultations with the Drugs Technical Advisory Board (DTAB).
WHY THE MINISTRY IS PROPOSING CURBS
The amendment aims to strengthen oversight of prescription drug advertising across the pharmaceutical supply chain, discourage unauthorised promotion and reduce the risks of inappropriate self-medication.
The medicines covered include certain antibiotics, psychotropic medicines and other drugs that require medical supervision.
The proposal follows recommendations from the DTAB’s 93rd meeting, held on February 16, 2026, which considered provisions to regulate advertisements by drug sale and distribution licence holders.
The amendment has not yet been finalised. The ministry has invited objections and suggestions from stakeholders and the public within 30 days of the date on which copies of the Gazette containing the draft rules are made available to the public.
The central government will consider submissions received within that period before finalising the amendment.
With inputs from ANI