The center moves to the bar of retailers, wholesalers of prescription drug advertising

NEW DELHI: The health ministry has decided to plug a major regulatory gap in the pharmaceutical supply chain by proposing strict restrictions on prescription drug advertisements by retailers, wholesalers and distributors, the government said on Friday.

The government wants to ensure that marketing restrictions on effective drugs are no longer limited to drug manufacturers.

It said the draft rules proposing the change were announced in the official gazette on September 28. The draft rules were issued after detailed consultations with the Drugs Technical Advisory Board (DTAB).

“Under the existing regulatory framework, drug manufacturers are prohibited from promoting drugs included in Schedule H, Schedule H1 and Schedule X without prior approval from the central government. However, the corresponding provisions do not explicitly cover entities involved in the retail and wholesale sale and distribution of these drugs,” the health ministry said in a statement.

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As part of this plan, the Ministry of Health proposed new regulatory measures under Rule 65 of the Drugs Rules, 1945.

“No advertisement shall be made for medicines listed in Schedule H, Schedule H1 or Schedule X, except with the prior sanction of the Central Government,” the ministry said.

The center solicited objections and suggestions from stakeholders and the public on the proposed rules within 30 days. Submissions received within the stipulated period will be considered by the Central Government before finalizing the change.

The measures apply to all entities licensed to sell, store, display, offer for sale or distribute medicines, effectively bringing brick-and-mortar pharmacies, large distributors and online pharmacy platforms under central control.

Mint reported on 21 November 2025 about growing regulatory concerns about prescription drug promotion and the government’s intention to restrict advertising by distributors and retailers.

Stronger surveillance

“The proposed amendment is intended to strengthen regulatory oversight of the pharmaceutical supply chain, deter unauthorized promotion of prescription drugs, and reduce risks associated with inappropriate self-medication,” the Ministry of Health said.

Intervention is critical because Schedule H, Schedule H1 and Schedule X include active substances that require close medical supervision, from critical antibiotics and anti-tuberculosis drugs to psychotropic and addictive drugs.

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Highlighting these clinical risks, the ministry said the measure is expected to “enhance safeguards for medicines that require proper medical supervision, including some antibiotics, psychotropic medicines and other prescription medicines”.

The amendment is based on recommendations finalized during the 93rd meeting of the DTAB on February 16, where drug experts pointed out the absence of advertising provisions for distribution license holders.