India
Centre Proposes Expanding Advertising Restrictions to Include Retailers and Wholesalers of Schedule H, H1, and X Drugs
The government has announced draft rules that would extend advertising restrictions on potent medicines to include retailers and wholesalers, not just manufacturers. The draft, notified in the official gazette on 28 September, follows consultations with the Drugs Technical Advisory Board (DTAB). Under the current framework, manufacturers of drugs listed in Schedule H, H1 and X cannot advertise without central government approval, but the rules do not explicitly cover entities that sell, stock, exhibit, offer for sale or distribute these medicines. The health ministry says the new measures, to be implemented under Rule 65 of the Drugs Rules, 1945, will bring brick‑and‑mortar chemists, large distributors and online pharmacy platforms under central scrutiny. The ministry has invited objections and suggestions from stakeholders and the public for 30 days; submissions received will be considered before the amendment is finalized. Mint reported on 21 November 2025 that the amendment aims to strengthen oversight across the pharmaceutical supply chain, discourage unauthorized promotion of prescription medicines and reduce risks of inappropriate self‑medication. The change comes after the DTAB’s 93rd meeting on 16 February, where experts noted the lack of advertising provisions for distribution licence holders. The amendment is intended to reinforce safeguards for medicines that require medical supervision, including certain antibiotics, psychotropic medicines and other prescription‑only drugs.