NEW DELHI: The Union Ministry of Health and Family Welfare has proposed stricter regulations on the advertising of prescription medicines by explicitly extending existing restrictions to cover retailers, wholesalers, and distributors.
The proposed amendment to the Drugs Rules, 1945, seeks to make prior approval from the Central Government strictly mandatory for any advertisements relating to medicines listed under Schedule H, Schedule H1, and Schedule X.
The draft amendment has been officially notified through Gazette Notification G.S.R. 861(E), dated September 28, 2026, following thorough consultations with the Drugs Technical Advisory Board (DTAB).
Closing the Regulatory Gap
Under the existing legal framework, pharmaceutical manufacturers are strictly prohibited from advertising medicines covered under these specific schedules without prior approval from the Central Government. However, the current provisions do not explicitly extend the same restrictions to entities involved in the retail, wholesale, and distribution of these drugs.
To address this regulatory gap, the Ministry has proposed inserting sub-rule (22) under Rule 65 of the Drugs Rules, 1945. This new provision will comprehensively extend the advertising restrictions to all license holders authorized to sell, stock, exhibit, offer for sale, or distribute medicines.
The restrictions will comprehensively cover medicines requiring active medical supervision, including certain antibiotics, psychotropic medicines, and other prescription-only drugs.
Rationale and Next Steps
The proposed regulatory measure aims to strongly fortify oversight across the entire pharmaceutical supply chain, curb the unauthorized promotion of prescription medicines, and significantly reduce the severe health risks associated with inappropriate self-medication.
The proposal follows key recommendations made during the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, 2026, which formally examined the pressing need for provisions regulating advertisements by drug sale and distribution license holders.
The Ministry has invited objections and suggestions regarding the draft amendment from stakeholders and members of the general public. Submissions can be made within 30 days from the date the Gazette notification was made available to the public. The Central Government will review all received feedback before the amendment is officially finalized.
