The Union Ministry of Health and Family Welfare has proposed tighter controls on the advertising of prescription medicines by retail chemists, wholesalers and other drug distributors through a draft amendment to the Drugs Rules, 1945.
The proposal, notified through Gazette Notification G.S.R. 861(E), dated 28 September 2026, seeks to extend advertising restrictions for medicines listed under Schedule H, Schedule H1 and Schedule X to entities holding licences for the sale and distribution of drugs.
The draft amendment proposes inserting a new sub-rule (22) under Rule 65 of the Drugs Rules, 1945. Under the proposed provision, advertisements for drugs specified in these schedules would not be permitted without the previous sanction of the Central Government.
The proposal is intended to strengthen regulatory oversight of prescription medicine promotion across the pharmaceutical supply chain and address the existing gap in provisions applicable to drug retailers and wholesalers.
The proposed sub-rule states: “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 provision would extend the advertising restriction to drug sale and distribution licence holders, including retailers and wholesalers, rather than limiting the relevant regulatory requirement to pharmaceutical manufacturers.
If finalised in its proposed form, the amendment would introduce an explicit restriction under Rule 65 for advertisements by these licence holders. The draft does not itself establish that the amendment is already in force.
The proposal covers medicines listed under three schedules of the Drugs Rules, 1945.
Schedule H: Prescription medicines that are subject to specified sale restrictions.
Schedule H1: Medicines subject to additional prescription and record-keeping requirements, including certain antibiotics and other specified drugs.
Schedule X: Specified medicines subject to stringent controls on sale and related record-keeping.
These categories include medicines for which appropriate medical supervision is important. The proposed restriction concerns advertising and does not, by itself, change the existing prescription, dispensing or sale requirements applicable to the medicines.
The proposal follows recommendations considered at the 93rd meeting of the Drugs Technical Advisory Board (DTAB), held on 16 February 2026. The amendment is intended to strengthen safeguards against unauthorised promotion of prescription medicines by entities involved in their sale and distribution. The government aims to improve regulatory oversight and reduce the potential risks associated with inappropriate self-medication.
By extending the explicit advertising restriction to drug licence holders, the proposal seeks to establish a more comprehensive framework covering different participants in the pharmaceutical supply chain.
The Ministry has invited objections and suggestions from stakeholders and members of the public regarding the draft rules. Under Gazette Notification G.S.R. 861(E), submissions may be made within 30 days from the date on which copies of the Gazette containing the draft rules are made available to the public. The government will consider submissions received within the prescribed period before finalising the amendment.
The proposal represents a step towards strengthening controls over the advertising of prescription medicines in India. Its final scope and implementation will depend on the government's consideration of stakeholder submissions and publication of the final amendment.
Until the final rules are published and brought into force, the proposal should be treated as a draft amendment rather than an already implemented regulatory change.
