Centre Moves To Bar Retailers, Wholesalers From Advertising Prescription Drugs

(MENAFN- Live Mint) NEW DELHI: The health ministry has moved to plug a major regulatory loophole in the pharmaceutical supply chain by proposing stringent curbs on advertisements of prescription drugs by retailers, wholesalers and distributors, the government said on Friday.

The government wants to ensure that marketing curbs on potent medicines are no longer restricted to pharmaceutical manufacturers.

It said the draft rules proposing the change have been notified in the official gazette on 28 September. The draft rules have been issued following detailed consultations with the Drugs Technical Advisory Board (DTAB).

“Under the existing regulatory framework, pharmaceutical manufacturers are prohibited from advertising drugs covered under Schedule H, Schedule H1 and Schedule X without prior sanction of the Central Government. However, corresponding provisions have not explicitly covered entities engaged in the retail and wholesale sale and distribution of these medicines,” the health ministry said in a statement.

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As part of the plan, the health ministry has proposed new regulatory measures under Rule 65 of the Drugs Rules, 1945.

“No advertisement of drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government,” the ministry said.

The Centre has invited objections and suggestions from stakeholders and members of the public on the proposed rules within 30 days. Submissions received within the prescribed period will be considered by the Central government before the amendment is finalized.

The measures cover all entities holding licences to sell, stock, exhibit, offer for sale or distribute medicines, effectively bringing brick-and-mortar chemists, large distributors and online pharmacy platforms under central scrutiny.

Mint reported on 21 November 2025 about the growing regulatory concerns over prescription drug promotions and the government's intent to restrict advertising by distributors and retailers.

Stronger oversight

“The proposed amendment is intended to strengthen regulatory oversight across the pharmaceutical supply chain, discourage unauthorized promotion of prescription medicines and reduce risks associated with inappropriate self-medication,” the health ministry said.

The intervention is critical as Schedule H, Schedule H1, and Schedule X encompass potent substances that require strict medical oversight, ranging from critical antibiotics and anti-tuberculosis medicines to psychotropic and habit-forming drugs.

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Highlighting these clinical risks, the ministry said the measure is expected to“reinforce safeguards relating to medicines that require appropriate medical supervision, including certain antibiotics, psychotropic medicines and other prescription-only drugs.”

The amendment stems from recommendations finalized during the 93rd meeting of the DTAB on 16 February, where drug experts flagged the absence of advertising provisions for distribution licence holders.

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