Health Ministry Proposes Ban on Prescription Drug Advertisements Without Prior Approval
New Delhi: The Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945, requiring drug retailers, wholesalers and distributors to obtain prior sanction from the Central Government before advertising medicines listed under Schedule H, Schedule H1 or Schedule X.
The proposal would extend an existing advertising restriction on pharmaceutical manufacturers to drug sale and distribution licence holders.
The Department of Health and Family Welfare issued the draft through notification G.S.R. 861(E), dated September 28, 2026, after consultation with the Drugs Technical Advisory Board (DTAB). The notification invokes the powers conferred by sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940).
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.
To address this regulatory gap, the Ministry has proposed the insertion of sub-rule (22) under Rule 65 of the Drugs Rules, 1945, extending the advertisement restriction to holders of licences to sell, stock, exhibit or offer for sale, or distribute drugs, including retail and wholesale drug licence holders.
The amendment proposes inserting a new sub-rule (22) in Rule 65, immediately after sub-rule (21). The proposed provision reads:
“(22) No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.”
The three schedules identify medicines subject to prescription and other regulatory controls, with additional safeguards applying to Schedule H1 and Schedule X drugs.
Schedule H covers prescription medicines that may be sold by retail only on and in accordance with a registered medical practitioner’s prescription. It is a statutory list of drug substances rather than a single therapeutic category.
Schedule H1 includes specified antibiotics, anti-tuberculosis medicines and certain medicines liable to misuse, with examples including cefixime and alprazolam. Besides requiring a prescription, their supply must be recorded in a separate register containing the prescriber’s name and address, the patient’s name, the drug name and the quantity supplied. These records must be retained for three years and remain available for inspection.
Schedule X includes tightly controlled medicines such as amphetamine, methylphenidate and certain barbiturates. These require specific sale licences and additional records. Retail prescriptions must be issued in duplicate, with one copy retained by the licensee for two years. Storage must be in a dedicated locked cupboard or drawer, or a separate area accessible only to responsible persons.
According to the Ministry, extending advertising oversight across the supply chain is intended to discourage unauthorised promotion and reduce risks associated with inappropriate self-medication.
The proposed amendment is intended to strengthen regulatory oversight across the pharmaceutical supply chain, discourage unauthorised promotion of prescription medicines and reduce risks associated with inappropriate self-medication.
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 proposal follows the recommendations of the 93rd meeting of the Drugs Technical Advisory Board, held on 16 February 2026, which considered the need for appropriate provisions governing advertisements by drug sale and distribution licence holders.
The notification invites objections and suggestions from any person likely to be affected by the proposal. The Central Government will consider submissions received within 30 days from the date on which copies of the Gazette containing the draft rules are made available to the public. The draft rules will be taken into consideration on or after the expiry of that period.
Objections and suggestions may be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall-C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001, or emailed to drugsdiv-mohfw@gov.in.
To view the official notice, click the link below:
https://medicaldialogues.in/pdf_upload/2026/10/09/gsr-861e-479003.pdf
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