New Delhi : HL October 09, 2026
The Union Ministry of Health and Family Welfare has proposed stricter regulations on the advertising of prescription medicines by expanding existing restrictions to cover retail chemists, wholesale drug dealers and distributors. The proposed amendment to the Drugs Rules, 1945, aims to prevent unauthorised promotion of prescription-only medicines and strengthen public health safeguards.
The draft amendment was notified through Gazette Notification G.S.R. 861(E), dated September 28, 2026, following consultations with the Drugs Technical Advisory Board (DTAB).
Proposed Amendment to the Drugs Rules, 1945
Under the existing regulatory framework, pharmaceutical manufacturers are prohibited from advertising medicines listed under Schedule H, Schedule H1 and Schedule X without prior approval from the Central Government. However, the corresponding restrictions have not explicitly covered all entities involved in the retail and wholesale sale and distribution of these medicines.
To address this gap, the Ministry has proposed inserting sub-rule (22) under Rule 65 of the Drugs Rules, 1945. The proposed provision would extend the advertising restrictions to holders of licences for selling, stocking, exhibiting or offering medicines for sale, as well as distributing drugs.
If finalised, the amendment would require retailers, wholesalers and other licensed drug distributors to obtain prior Central Government sanction before advertising medicines covered under Schedule H, H1 and X.
Focus on Preventing Unauthorised Promotion of Prescription Medicines
The proposed measure seeks to strengthen regulatory oversight across the pharmaceutical supply chain and discourage promotional activities that could encourage inappropriate use of prescription medicines.
Schedule H, H1 and X include medicines subject to prescription-related restrictions, including certain antibiotics, psychotropic medicines and other drugs that require appropriate medical supervision. Unregulated promotion of these medicines may contribute to inappropriate self-medication, misuse and other potential health risks.
By extending advertising restrictions to licensed drug sellers and distributors, the Ministry aims to ensure that the promotion of prescription medicines remains subject to appropriate regulatory control.
DTAB Recommendation Led to the Proposal
The proposed amendment follows recommendations made during the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, 2026. The Board considered the need for suitable provisions governing advertisements issued by entities holding licences for the sale and distribution of medicines.
The latest proposal seeks to address the regulatory gap by applying the existing advertising approval requirement more consistently across the pharmaceutical supply chain.
Public Invited to Submit Objections and Suggestions
The Ministry of Health and Family Welfare has invited objections and suggestions from stakeholders and members of the public regarding the draft amendment.
Submissions may be made within 30 days from the date on which copies of the Gazette notification containing the draft rules are made available to the public. The Central Government will consider the representations received within the prescribed period before deciding on the finalisation of the amendment.
Official Gazette Notification: https://egazette.gov.in/WriteReadData/2026/276941.pdf
