Health Ministry proposes curbs on prescription drug ads by pharmacies
Synopsis
Key Takeaways
The Union Ministry of Health and Family Welfare on 9 October 2026 released a draft amendment proposing stricter controls on the advertisement of prescription medicines, extending existing restrictions beyond pharmaceutical manufacturers to cover pharmacies, wholesalers, and other licensed drug sellers across India. The proposal marks a significant widening of regulatory oversight over prescription drug promotion in the country.
What the Draft Rules Propose
Under the draft amendment, medicines listed under Schedules H, H1, and X of the Drugs Rules, 1945 — which include several antibiotics, psychotropic substances, and other prescription-only drugs — would require prior approval from the Central Government before being advertised. The ministry has proposed inserting a new sub-rule (22) under Rule 65 of the Drugs Rules to formalise this wider scope.
Currently, advertisement restrictions apply primarily to pharmaceutical companies that manufacture these medicines. The proposed change would bring retail medical stores and wholesale drug dealers — entities licensed to sell, stock, exhibit, offer for sale, or distribute drugs — under the ambit of advertisement controls for the first time.
Why This Matters
Officials believe the proposed changes will reduce the risk of self-medication and ensure that medicines requiring professional medical supervision are not marketed directly to consumers without adequate safeguards. Schedule H alone covers more than 500 medicines commonly used in medical treatment, making the scope of the proposal significant.
Notably, the move is part of a broader effort to tighten controls over the sale of prescription drugs. Last month, the Health Ministry separately proposed making CCTV surveillance mandatory at all medical stores, with recordings required to be preserved for at least three months — a measure also aimed at curbing unauthorised access to Schedule H, H1, and X medicines.
Background: DTAB Recommendations
The draft amendment follows recommendations made during the 93rd meeting of the Drugs Technical Advisory Board (DTAB), held in February 2026. The board had identified a regulatory gap — existing law addressed advertisement by manufacturers but lacked explicit provisions covering licensees engaged in the sale and distribution of drugs. The current proposal is the ministry's legislative response to that gap.
What Happens Next
Stakeholders and members of the public have been invited to submit objections and suggestions within 30 days from the date copies of the Gazette notification containing the draft rules are made available. If notified in final form, the amendments are expected to strengthen regulatory safeguards around prescription drugs and enhance accountability across India's drug distribution network.