{"id":13367,"date":"2026-10-09T06:35:03","date_gmt":"2026-10-09T06:35:03","guid":{"rendered":"https:\/\/theeaglenews.co.in\/?p=13367"},"modified":"2026-10-09T06:35:03","modified_gmt":"2026-10-09T06:35:03","slug":"centre-proposes-tighter-restrictions-on-prescription-drug-advertisements-by-retailers-and-wholesalers","status":"publish","type":"post","link":"https:\/\/theeaglenews.co.in\/?p=13367","title":{"rendered":"Centre Proposes Tighter Restrictions on Prescription Drug Advertisements by Retailers and Wholesalers."},"content":{"rendered":"
<\/div>

Centre Proposes Tighter Restrictions on Prescription Drug Advertisements by Retailers and Wholesalers.<\/h1>\n

Draft amendment seeks to extend advertising restrictions on Schedule H, H1 and X medicines to retailers, wholesalers and distributors; public and stakeholders invited to submit suggestions within 30 days.<\/h2>\n

 <\/p>\n

New Delhi:<\/p>\n

 <\/p>\n

The Union Ministry of Health and Family Welfare has proposed stricter regulations on the advertising of prescription-only medicines by extending existing restrictions to retailers, wholesalers and distributors of drugs. The proposed amendment to the Drugs Rules, 1945, aims to prevent unauthorised promotion of prescription medicines, strengthen regulatory oversight and protect public health.<\/p>\n

The draft amendment has been notified through Gazette Notification G.S.R. 861(E), dated September 28, 2026, following consultations with the Drugs Technical Advisory Board (DTAB).<\/p>\n

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 do not explicitly cover entities involved in the retail and wholesale sale and distribution of these medicines.<\/p>\n

To address this regulatory gap, the Ministry has proposed inserting a new sub-rule, Rule 65(22), into the Drugs Rules, 1945. The proposed provision would extend the advertising restrictions to holders of licences to sell, stock, exhibit or offer for sale, or distribute drugs, including retail and wholesale licence holders.<\/p>\n

Prior Government Approval Proposed for Drug Advertisements<\/h4>\n

Under the proposed amendment, advertisements for medicines covered under Schedule H, Schedule H1 and Schedule X would not be permitted without the prior sanction of the Central Government.<\/p>\n

The move is intended to ensure that restrictions on the promotion of prescription medicines apply more comprehensively across the pharmaceutical supply chain, rather than being limited to manufacturers.<\/p>\n

The Ministry aims to discourage unauthorised advertising that could encourage inappropriate use of prescription medicines or lead people to take drugs without proper medical supervision.<\/p>\n

Focus on Public Health and Responsible Medicine Use<\/h4>\n

The proposed amendment is expected to strengthen safeguards for medicines that require medical supervision, including certain antibiotics, psychotropic medicines and other prescription-only drugs.<\/p>\n

Unauthorised promotion of such medicines can contribute to inappropriate self-medication and their use without adequate professional guidance. By extending the restrictions to retailers, wholesalers and distributors, the government intends to reinforce responsible medicine practices and improve compliance with existing drug regulations.<\/p>\n

The proposal also seeks to establish more consistent regulatory oversight of advertising activities undertaken by different categories of businesses involved in the sale and distribution of medicines.<\/p>\n

Proposal Based on DTAB Recommendations<\/h4>\n

The proposed amendment follows recommendations made during the 93rd meeting of the Drugs Technical Advisory Board, held on February 16, 2026.<\/p>\n

The Board considered the need for appropriate regulatory provisions governing advertisements issued by holders of licences for the sale and distribution of drugs. Following these deliberations, the Ministry initiated the process to amend the existing rules.<\/p>\n

The proposed changes are intended to close the gap in the current regulatory framework and ensure that businesses dealing in prescription medicines are subject to the applicable advertising restrictions.<\/p>\n

Public Invited to Submit Objections and Suggestions<\/h4>\n

The Union Health Ministry has invited objections and suggestions from stakeholders and members of the public on the draft amendment.<\/p>\n

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 finalising the amendment.<\/p>\n

The proposal is currently at the draft stage. Its final provisions will depend on the government’s consideration of the objections and suggestions received during the consultation process.<\/p>\n

If finalised, the amendment would expand the scope of existing restrictions on prescription drug advertising and strengthen safeguards against the unauthorised promotion of medicines across the pharmaceutical distribution network.<\/p>\n","protected":false},"excerpt":{"rendered":"

Centre Proposes Tighter Restrictions on Prescription Drug Advertisements by Retailers and Wholesalers. Draft amendment seeks to extend advertising restrictions on Schedule H, H1 and X […]<\/p>\n

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