New Delhi, 09 October (H.S.):

The Union Ministry of Health and Family Welfare is preparing to tighten regulations governing the advertising of prescription medicines, proposing to extend advertising restrictions beyond pharmaceutical manufacturers to include retailers, wholesalers and distributors.

According to a statement issued by the Ministry on Friday, the proposed measure aims to prevent unauthorised drug promotion and protect people from the potential health risks associated with taking medicines without medical advice.

The Ministry has notified a draft amendment to the Drugs Rules, 1945. Under Gazette Notification No. G.S.R. 861(E), issued on September 28, 2026, the government has proposed the insertion of a new sub-rule (22) under Rule 65. The amendment is currently at the draft stage, and objections and suggestions have been invited from stakeholders and the public.

Retailers and Wholesalers Also to Face Restrictions

Under the existing rules, pharmaceutical manufacturers are required to obtain prior permission from the Central Government to advertise medicines covered under Schedules H, H1 and X. However, the advertising restrictions were not explicitly extended to businesses holding licences for the retail sale, wholesale sale or distribution of these medicines.

Under the proposed amendment, the restrictions would also apply to establishments licensed to sell, stock, exhibit, offer for sale or distribute medicines falling under these categories. Such businesses would not be permitted to advertise the medicines concerned without obtaining prior approval from the Central Government.

According to the Ministry, the initiative would strengthen regulatory oversight across the pharmaceutical supply and distribution chain. It would also help curb promotional activities that could encourage people to take medicines without consulting a qualified medical practitioner.

Schedules H, H1 and X cover medicines that require medical supervision and are subject to specific regulatory controls. These include certain antibiotics, psychotropic medicines and other controlled drugs. Their inappropriate or unsupervised use can pose significant risks to public health.

The Ministry has prepared the proposal following recommendations made at the 93rd meeting of the Drugs Technical Advisory Board (DTAB), held on February 16, 2026. During the meeting, the Board considered the need for appropriate regulatory provisions to govern advertisements issued by businesses holding licences for the sale and distribution of medicines.

The Ministry has invited objections and suggestions from members of the public and other stakeholders on the draft rules. Submissions may be made within 30 days from the date on which copies of the Gazette notification are made publicly available.

After examining the objections and suggestions received within the prescribed period, the Central Government will decide on the finalisation of the proposed amendment.

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Hindusthan Samachar / Jun Sarkar