Union Health Ministry Proposes Tighter Curbs on Advertising of Prescription Drugs by Retailers and Wholesalers

Key Highlights:

• The Union Health Ministry has proposed an amendment to the Drugs Rules, 1945, to tighten curbs on advertising prescription drugs.
• The amendment aims to extend the requirement of prior Central Government sanction for advertising to drug retailers and wholesalers.
• This restriction applies to drugs specified under Schedule H, Schedule H1, and Schedule X.
• The draft amendment was notified via Gazette Notification G.S.R. 861(E) on 28 September 2026.
• The proposal follows recommendations from the 93rd meeting of the Drugs Technical Advisory Board (DTAB).

Detailed Insights:

• The proposed amendment addresses a regulatory gap, as existing provisions primarily covered pharmaceutical manufacturers but not distributors.
• It seeks to insert sub-rule (22) under Rule 65 of the Drugs Rules, 1945, to cover all licence holders involved in drug sale and distribution.
• The measure aims to strengthen regulatory oversight, discourage unauthorized promotion, and reduce risks of inappropriate self-medication.
• It will reinforce safeguards for medicines requiring medical supervision, such as certain antibiotics and psychotropic drugs.
• Public and stakeholders have been invited to submit objections and suggestions within 30 days for consideration.

Key Concepts Involved:

• Drugs Rules, 1945: Rules framed under the Drugs and Cosmetics Act, 1940, governing drug manufacturing, sale, and distribution in India.
• Schedule H, H1, X: Categories within the Drugs and Cosmetics Rules, 1945, listing drugs that require a prescription and have specific dispensing regulations.
• Drugs Technical Advisory Board (DTAB): A statutory body that advises the Central and State Governments on technical matters arising from the administration of the Drugs and Cosmetics Act, 1940.