Archive · 9 Oct 2026
Centre Proposes Tighter Prescription Drug Advertising Curbs Across Supply Chain
The government has proposed new rules about advertising some medicines that need a prescription.
Right now, manufacturers need government permission before advertising these medicines.
The draft would extend that rule to licensed retailers, wholesalers and distributors too.
It covers medicines listed in Schedules H, H1 and X. The Health Ministry says this could help stop unauthorised promotion and reduce unsafe self-medication.
The proposal follows a recommendation from a government advisory board.
It is still only a draft, so it is not yet a final rule.
People and organisations can send comments within 30 days after the draft notice is made available.
The Health Ministry proposes requiring prior Central Government approval to advertise Schedule H, H1 and X medicines.
The draft would extend existing advertising restrictions from manufacturers to licensed retailers, wholesalers and distributors.
The proposal would add a new sub-rule under Rule 65 of the Drugs Rules, 1945.
The move follows recommendations made at the Drugs Technical Advisory Board’s 93rd meeting on February 16, 2026.
The draft was notified on September 28, 2026, and invites public and stakeholder comments within 30 days of its availability.
- Who
- The Union Health Ministry proposed the draft; it would cover licence holders including retailers, wholesalers and distributors.
- What
- The proposal would require prior Central Government approval for advertisements of Schedule H, H1 and X medicines.
- When
- The Gazette notification is dated September 28, 2026; the proposal followed a DTAB meeting on February 16, 2026.
- Where
- India, under the Drugs Rules, 1945.
- Why
- The ministry says the change would close a regulatory gap, strengthen oversight, curb unauthorised promotion and reduce risks from inappropriate self-medication.
Government’s stated rationale
Potential impact on regulated businesses
Purpose and effect
Government’s stated rationale
The ministry says extending approval requirements across the supply chain would strengthen oversight, discourage unauthorised promotion and help reduce inappropriate self-medication.
Potential impact on regulated businesses
The proposal would add a compliance requirement for retailers, wholesalers and distributors seeking to promote the covered medicines; the articles do not report a formal opposition from these businesses.
Finalisation
Government’s stated rationale
The government says it will consider public and stakeholder submissions before deciding whether to finalise the amendment.
Potential impact on regulated businesses
The change remains a draft, and its final form and implementation depend on the government’s decision after the comment period.
- Draft notification
- G.S.R. 861(E)
- Notification date
- September 28, 2026
- Rules affected
- Drugs Rules, 1945
- Proposed provision
- New sub-rule (22) under Rule 65
- Medicines covered
- Schedule H, Schedule H1 and Schedule X medicines
- DTAB recommendation
- 93rd meeting, held February 16, 2026
- Comment period
- 30 days after the draft Gazette notification is made available
- Status
- Draft; submissions will be considered before any final decision
