NEW DELHI, October 9 – The Union Ministry of Health and Family Welfare has put forth a proposal to amend the Drugs Rules, 1945, aiming to enhance regulatory control over advertisements for prescription-only medicines. The proposed changes seek to extend existing restrictions on advertising certain drugs to entities involved in their sale and distribution, including retailers and wholesalers.
Information was available with The Chenab Times that the draft amendment was notified via Gazette Notification G.S.R. 861(E) on September 28, 2026, following deliberations with the Drugs Technical Advisory Board (DTAB). This move addresses a regulatory gap where, despite a prohibition on drug manufacturers advertising Schedule H, H1, and X drugs without Central Government sanction, similar provisions did not explicitly cover retail and wholesale distributors.
The Ministry intends to introduce sub-rule (22) under Rule 65 of the Drugs Rules, 1945. This addition would specifically prohibit holders of licences for selling, stocking, exhibiting, or offering for sale, or distributing drugs, from making advertisements without prior Central Government approval. This would encompass all drug licence holders, including those operating at the retail and wholesale levels.
The primary objective behind this proposed amendment is to strengthen oversight across the entire pharmaceutical supply chain. Authorities aim to discourage the unauthorised promotion of medicines that require a prescription and to mitigate the risks associated with individuals self-medicating without appropriate medical guidance. The measure is designed to reinforce the safeguards surrounding medicines that necessitate professional medical supervision, such as certain antibiotics, psychotropic drugs, and other prescription-only formulations.
This regulatory proposal stems from recommendations made during the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, 2026. At this meeting, the board underscored the necessity for explicit provisions to govern advertisements made by drug sale and distribution licence holders.
The Ministry has officially invited objections and suggestions from all stakeholders and members of the public. These inputs must be submitted within a 30-day period commencing from the date the Gazette containing the draft rules becomes accessible. All submissions received within this stipulated timeframe will be carefully considered by the Central Government before the amendment is finalised and implemented.
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The Chenab Times News Desk
