Health Ministry Draft Rule: Chemists, Wholesalers Need Govt Nod to Advertise Schedule H, H1, X Drugs; Comments in 30 Days
The Health Ministry has proposed amending Rule 65 of the Drugs Rules, 1945 so that retailers, wholesalers and distributors need Central Government approval to advertise Schedule H, H1 and X drugs. The public can comment within 30 days.
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Health Ministry Proposes Curbs on Prescription Drug Ads by Chemists: Overview
The Union Ministry of Health and Family Welfare has proposed a new rule to stop chemists, pharmacies, wholesalers and distributors from advertising prescription-only medicines without government approval. The proposal was announced through a Press Information Bureau (PIB) release on 9 October 2026. It is part of a draft notification, G.S.R. 861(E) dated 28 September 2026, published in the Gazette of India to amend the Drugs Rules, 1945.
At present, the requirement of prior approval from the Central Government for advertising such medicines applies to manufacturers. The new draft extends it to the retail and wholesale chain as well. Since this is a draft, the public and stakeholders can send objections and suggestions within 30 days. Here is a simple explanation of what is proposed and why it matters for common people.
| Particular | Details |
|---|---|
| Ministry | Ministry of Health and Family Welfare |
| Announced through | PIB press release, 9 October 2026 |
| Draft notification | G.S.R. 861(E), dated 28 September 2026 |
| Law being amended | Drugs Rules, 1945 |
| Proposed change | Insertion of new sub-rule (22) in Rule 65 |
| Medicines covered | Drugs in Schedule H, Schedule H1 and Schedule X |
| Who is covered | Licence holders who sell, stock, exhibit, offer for sale or distribute drugs, including retail and wholesale licence holders |
| Basis | Recommendations of the 93rd meeting of the Drugs Technical Advisory Board (DTAB), held on 16 February 2026 |
| Status | Draft, open for public comments |
| Comment period | 30 days from the date copies of the Gazette are made available to the public |
Key Dates
| Event | Date |
|---|---|
| 93rd DTAB meeting | 16 February 2026 |
| Draft notification G.S.R. 861(E) | 28 September 2026 |
| PIB press release | 9 October 2026 |
| Objections and suggestions | Within 30 days from the date the Gazette copies are made available to the public |
The PIB release does not give a fixed calendar end date for comments, so readers should check the Gazette notification for the exact details.
What Exactly Is Being Proposed?
As per the PIB release, the Ministry proposes to insert a new sub-rule (22) under Rule 65 of the Drugs Rules, 1945. Under the proposal:
- The existing requirement of prior sanction of the Central Government for advertising drugs in Schedule H, H1 and X will be extended beyond manufacturers.
- It will now also cover holders of licences to sell, stock, exhibit, offer for sale or distribute drugs, including retail and wholesale licence holders.
- In simple words, a chemist shop, pharmacy chain, wholesaler or distributor will not be able to advertise these prescription medicines without first getting Central Government approval.
The PIB release says the existing provisions do not clearly cover retailers, wholesalers and distributors, and this draft aims to close that gap.
Why Has the Government Proposed This?
The Health Ministry has given these reasons in its release:
- To strengthen regulatory oversight across the entire drug supply chain.
- To discourage unauthorised promotion of prescription-only medicines.
- To reduce the risks of self-medication.
- To strengthen safeguards for medicines that need medical supervision, such as certain antibiotics and psychotropic drugs.
The proposal follows the recommendations of the 93rd meeting of the Drugs Technical Advisory Board (DTAB), held on 16 February 2026.
What Does It Mean for Common People?
- Fewer ads pushing prescription medicines: If the rule is finalised, sellers cannot promote Schedule H, H1 or X medicines on their own without approval.
- Safer use of medicines: The government's stated aim is to reduce self-medication, especially for antibiotics and psychotropic drugs that need a doctor's supervision.
- Focus is on advertising: As described in the PIB release, the draft deals with advertisements of these medicines by sellers and distributors.
- Your voice counts: Since it is a draft, any citizen can send objections or suggestions within the 30-day period.
What Does It Mean for Chemists, Pharmacies and Distributors?
Retail and wholesale drug licence holders, including distributors, will need prior Central Government approval before releasing any advertisement for Schedule H, H1 or X drugs, once the rule is notified in final form. Businesses that run promotions, banners or online campaigns for such medicines should study the draft and send their views within the comment period.
Related Recent Draft Rules
This is not the only recent draft on drug sales. The CDSCO Gazette Notifications page lists G.S.R. 791(E), released on 8 September 2026, a draft amendment to the Drugs Rules, 1945 on mandatory CCTV surveillance at sales premises. Readers can track all such notifications on the CDSCO website.
How to Read the Draft and Send Your Comments
- Read the PIB press release dated 9 October 2026 (links below).
- Open the Gazette of India draft notification G.S.R. 861(E) from egazette.gov.in.
- Check the address and method for objections given in the Gazette notification.
- Send your objections or suggestions within 30 days from the date the Gazette copies are made available to the public. The Ministry says comments received in this period will be considered before finalising the rule.
- Track the final notification on the CDSCO Gazette Notifications page.
Important Official Links
| Document | Link |
|---|---|
| PIB press release (English) | Read Release |
| PIB press release (Hindi) | Read Release |
| Gazette draft G.S.R. 861(E) | View Gazette |
| CDSCO Gazette Notifications | CDSCO Page |
Frequently Asked Questions
Has the rule come into force?
No. It is a draft (G.S.R. 861(E) dated 28 September 2026). It will be finalised only after considering public comments.
Which medicines are covered?
Drugs listed in Schedule H, Schedule H1 and Schedule X of the Drugs Rules, 1945, which are prescription-only medicines.
Who will need government approval to advertise?
Licence holders who sell, stock, exhibit, offer for sale or distribute such drugs, including retail and wholesale licence holders. Manufacturers already need prior approval.
How long can people send objections?
Within 30 days from the date copies of the Gazette containing the draft are made available to the public.
Why is the government doing this?
To strengthen oversight of the supply chain, stop unauthorised promotion of prescription drugs and reduce the risks of self-medication.
Conclusion
The Health Ministry's draft amendment to Rule 65 of the Drugs Rules, 1945 aims to stop chemists, wholesalers and distributors from advertising prescription-only medicines without Central Government approval. It is a consumer safety step against self-medication. Since it is still a draft, citizens and traders can send their views within 30 days of the Gazette being made public.
References
- https://www.pib.gov.in/PressReleasePage.aspx?PRID=2321172 – PIB, "Union Health Ministry Proposes Tighter Curbs on Advertising of Prescription Drugs by Retailers and Wholesalers", Ministry of Health and Family Welfare, 9 October 2026
- https://www.pib.gov.in/PressReleasePage.aspx?PRID=2321260 – PIB (Hindi), same press release, Ministry of Health and Family Welfare, 9 October 2026
- https://egazette.gov.in/WriteReadData/2026/276941.pdf – Gazette of India, draft notification G.S.R. 861(E), 28 September 2026 (as linked in the PIB release)
- https://www.cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notifications – CDSCO, Gazette Notifications list (G.S.R. 791(E), released 8 September 2026), accessed 9 October 2026