The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to extend restrictions on prescription drug advertising to retailers, wholesalers and distributors. The move aims to prevent unauthorised promotion of prescription medicines and reduce the risks associated with inappropriate self-medication.

The draft amendment, notified through Gazette Notification G.S.R. 861(E), dated September 28, 2026, proposes inserting a new sub-rule under Rule 65. It would require prior Central Government approval for advertisements of medicines covered under Schedules H, H1 and X by entities licensed to sell or distribute these drugs.

Schedule H medicines generally require a valid prescription, while Schedule H1 includes specified medicines subject to additional controls and record-keeping requirements, including certain antibiotics. Schedule X medicines are subject to stricter regulatory controls because of their potential for misuse and dependence.

The proposed amendment seeks to address a regulatory gap by extending advertising restrictions to licensed pharmacies, wholesalers, distributors and other drug-sale licence holders. Existing provisions already restrict pharmaceutical manufacturers from advertising these medicines without prior government approval.

The proposal follows recommendations made during the 93rd meeting of the Drugs Technical Advisory Board (DTAB), held on February 16, 2026. The government has invited objections and suggestions from stakeholders and members of the public within 30 days of the draft rules being made available in the Gazette.

The proposed changes aim to strengthen oversight across the pharmaceutical supply chain and discourage promotional practices that could encourage inappropriate medicine use. Unsupervised antibiotic use can contribute to antimicrobial resistance, while misuse of certain controlled medicines can lead to dependence and other adverse health outcomes.

The amendment remains at the draft stage and is not yet a finalised rule. Stakeholder feedback will be considered before the Central Government decides whether to implement the proposed changes.