The Union Ministry of Health and Family Welfare has proposed an amendment to the Drugs Rules, 1945, to prevent retail chemists, wholesalers and drug distributors from advertising prescription medicines without prior approval from the Central Government. The move aims to close a regulatory gap by extending existing restrictions on pharmaceutical manufacturers to all entities in the supply chain. The draft amendment was published in the Gazette on 28 September 2026.
Key facts
- Draft amendment notified as G.S.R. 861(E) on 28 September 2026
- Applies to Schedule H, Schedule H1 and Schedule X medicines
- Proposed insertion of sub-rule (22) under Rule 65 of the Drugs Rules, 1945
- 30-day public consultation period for objections and suggestions
- Recommendation from 93rd meeting of Drugs Technical Advisory Board held on 16 February 2026
- Covers retail drug licences, wholesale licences and distributors
What the current rules say
Under existing regulations, pharmaceutical manufacturers have been prohibited from advertising drugs in Schedules H, H1 and X without obtaining prior sanction from the Central Government. These three schedules cover prescription-only medicines that require medical supervision, such as certain antibiotics, psychotropic drugs and other controlled substances. However, the rules have not explicitly extended this restriction to chemists, drug wholesalers and distributors who sell these medicines to the public.
What the new rule will change
The proposed amendment will explicitly ban retailers, wholesalers and distributors holding drug sale and distribution licences from advertising any Schedule H, H1 or X medicines unless they first obtain Central Government approval. This means a chemist shop cannot advertise such medicines in newspapers, online, on boards outside the shop, or through any other medium without prior permission. The rule will apply across the pharmaceutical supply chain and aims to prevent unauthorised promotion of medicines that should only be sold on medical prescription.
Why this matters
The change addresses a loophole in the current regulatory framework. While manufacturers face restrictions, retailers and wholesalers have been able to advertise these prescription-only medicines directly to consumers without government oversight. Such advertising can encourage people to self-medicate without consulting a doctor, leading to inappropriate use of antibiotics, psychotropic medicines and other dangerous drugs. This can result in antibiotic resistance, addiction, adverse health outcomes and other public health risks. By extending the restriction across all supply chain entities, the Ministry aims to strengthen safeguards for medicines that require professional medical guidance.
Who this affects
The primary impact will be on retail chemists, drug wholesalers and distributors. They will need to obtain Central Government sanction before advertising any Schedule H, H1 or X medicines. In practice, most small and medium retailers are unlikely to seek such approval, effectively preventing them from advertising these medicines. Patients and consumers will also be affected because they will see fewer advertisements promoting prescription medicines, reducing the risk of inappropriate self-medication. Pharmaceutical manufacturers were already subject to this restriction, so their operations remain largely unchanged.
Public consultation period
The draft amendment is open for public feedback. The Ministry has invited objections and suggestions from stakeholders, industry bodies, professional associations and members of the public for 30 days from the date copies of the Gazette notification become available to the public. All submissions received within this period will be considered by the Central Government before the rules are finalised and notified. The full text of the draft amendment is available in the Official Gazette.
What happens next
The Ministry will review all public comments and feedback received during the consultation period. After considering the responses, the Central Government will finalise the amendment and issue it as a binding rule. Once notified as final, the amendment will become law, and all drug retailers, wholesalers and distributors will be legally required to comply with the new advertising restrictions on prescription medicines.