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Govt Moves to Control Prescription Drug Ads Across Supply Chain
10 Oct
Summary
- New rules propose extending ad restrictions to drug retailers and wholesalers.
- Amendment targets unauthorized promotion of prescription medicines.
- Stakeholders have 30 days to submit objections to the proposed changes.
The Union Health Ministry has initiated a move to amend the Drugs Rules, 1945, by proposing new restrictions on the advertisement of prescription medicines. This proposed amendment specifically targets drug retailers, wholesalers, and distributors, aiming to extend regulations that currently apply only to pharmaceutical manufacturers. The goal is to close a significant regulatory gap concerning the promotion of drugs listed under Schedules H, H1, and X.
The draft amendment, notified on September 28, 2026, seeks to prohibit any entity holding a license to sell, stock, exhibit, offer for sale, or distribute these scheduled drugs from advertising them without prior Central government approval. This extension across the drug supply chain is intended to enhance oversight and mitigate risks associated with the inappropriate self-medication of prescription drugs.
These scheduled medicines often require medical supervision, such as certain antibiotics and psychotropic substances. The unauthorized promotion of such drugs can lead to their misuse without proper medical advice, posing risks to patient safety. The proposal stems from recommendations made by the Drugs Technical Advisory Board (DTAB) on February 16, 2026.
Objections and suggestions from the public and stakeholders are invited within 30 days of the Gazette notification's availability. The Central government will consider all submissions before finalizing the amendment, ensuring a comprehensive review of the proposed regulatory changes.
