New Delhi: The Union Ministry of Health and Family Welfare has proposed tighter restrictions on advertisements for prescription medicines, seeking to extend existing regulatory requirements to pharmacies, wholesalers and other licensed drug distributors.
The proposed amendment to the Drugs Rules, 1945, would require prior approval from the Central Government before advertisements for medicines covered under Schedules H, H1 and X can be issued by entities licensed to sell or distribute them.
The draft 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 Cover Retailers and Wholesalers
Under the existing framework, pharmaceutical manufacturers cannot advertise medicines listed under Schedules H, H1 and X without prior Central Government approval. However, the corresponding restriction does not explicitly cover all licensed entities involved in retail and wholesale sales and distribution.
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To address this gap, the government has proposed inserting a new sub-rule, Rule 65(22), into the Drugs Rules, 1945.
If finalised, the provision would extend the advertising restriction to holders of licences to sell, stock, exhibit or offer drugs for sale, or distribute them.
The proposed changes would cover:
- Retail pharmacies: Drug retailers holding licences to sell prescription medicines.
- Wholesalers: Licensed businesses supplying medicines to pharmacies and other authorised buyers.
- Distributors: Entities holding licences for the distribution of the specified medicines.
Under the proposal, advertisements for medicines covered by Schedules H, H1 and X would require prior Central Government sanction.
Which Medicines Would Be Covered?
The proposed restrictions concern medicines listed under three schedules of the Drugs Rules, 1945.
- Schedule H: Prescription medicines that can be sold only under the applicable prescription requirements.
- Schedule H1: Specified medicines subject to additional controls, including certain antibiotics and anti-tuberculosis drugs.
- Schedule X: Certain medicines subject to stricter controls, including specific narcotic and psychotropic drugs.
The proposed amendment is intended to strengthen oversight of how these medicines are promoted and reduce risks associated with inappropriate self-medication.
Proposal Follows Drugs Technical Advisory Board Recommendations
The proposal follows discussions at the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, 2026.
The board considered the need for specific provisions to regulate advertisements issued by entities licensed to sell and distribute medicines covered under Schedules H, H1 and X.
The amendment seeks to extend regulatory oversight beyond pharmaceutical manufacturers to other businesses involved in the medicine supply chain.
Government Invites Public Feedback
The Health Ministry has invited objections and suggestions from stakeholders and members of the public on the draft amendment.
Submissions can be made within 30 days from the date on which copies of the relevant Gazette notification are made available to the public. The government will consider the submissions before finalising the amendment.
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