Source: Press Information Bureau (PIB), Government of India — Ministry of Health and Family Welfare · PIB Delhi · Read the original release on pib.gov.in
- Draft extends Centre's prior sanction rule for prescription drug ads to licence holders
- શેડ્યૂલ H, H1 અને X દવાઓ વેચતા છૂટક, જથ્થાબંધ અને વિતરણ લાયસન્સ ધારકોને આવરી લે છે
- Proposed as Rule 65 sub-rule (22) of the Drugs Rules, 1945
- Public has 30 days from Gazette availability to file objections and suggestions
The Centre has proposed extending its prior sanction rule for prescription drug advertisements to retailers and wholesalers. The Union Ministry of Health and Family Welfare has issued a draft amendment to the Drugs Rules, 1945, to tighten oversight of ads for prescription-only medicines.
What the draft changes
દવા ઉત્પાદકોને શેડ્યૂલ H, શેડ્યૂલ H1 અને શેડ્યૂલ X દવાઓની જાહેરાત કરવા માટે પહેલાથી જ કેન્દ્ર સરકારની મંજૂરીની જરૂર છે. નિયમો સ્પષ્ટપણે આ દવાઓના છૂટક અને જથ્થાબંધ વિક્રેતાઓ અથવા વિતરકોને આવરી લેતા નથી. ડ્રાફ્ટ તે અંતરને ભરે છે.
It proposes a new sub-rule (22) under Rule 65 of the Drugs Rules, 1945. Under it, no advertisement of these drugs can be made without the previous sanction of the Central Government. The restriction would apply to holders of licences to sell, stock, exhibit, offer for sale or distribute drugs.
Why the Ministry wants it
The move aims to curb unauthorised promotion of prescription medicines. It also seeks to reduce risks linked to inappropriate self-medication.
The Ministry expects the change to strengthen safeguards for medicines that need proper medical supervision. These include certain antibiotics, psychotropic medicines and other prescription-only drugs.
Background and next steps
The proposal follows recommendations from the 93rd meeting of the Drugs Technical Advisory Board, held on 16 February 2026. The draft was notified through Gazette Notification G.S.R. 861(E), dated 28 September 2026, after consultations with the board.
The Ministry has invited objections and suggestions from stakeholders and the public. The window is 30 days from the date copies of the Gazette containing the draft rules are made available to the public. The Central Government will consider all submissions before finalising the amendment.
This report is based on an official press release issued by the Press Information Bureau (PIB). The original release is linked above.
