Why in the News?
The Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945 to strengthen oversight of Schedule H, H1 and X drugs.
A key proposal is mandatory CCTV surveillance at medical stores to improve transparency and prevent unauthorized sale.
Key Highlights
- Draft Gazette Notification: G.S.R. 791 (E) dated 8 September 2026.
- Focus: Prevent unauthorized access and sale of Schedule H, H1 and X drugs.
- Mandatory CCTV surveillance has been proposed for medical stores.
- Objective:
- Strengthen monitoring of drug sales.
- Prevent sale without valid prescriptions.
- Improve transparency and accountability.
- Strengthen public-health safeguards.
Regulatory Process
- Proposal was initially deliberated by the Drugs Consultative Committee (DCC).
- It was subsequently circulated to the Drugs Technical Advisory Board (DTAB).
- DTAB recommended approval of the proposal.
- The Ministry has invited objections and suggestions from stakeholders and the public.
Schedule H, H1 and X
Schedule H
- Prescription-based medicines.
- Sale is subject to prescription requirements.
Schedule H1
- Contains specified medicines requiring stricter record-keeping and prescription controls.
- Includes certain medicines for which misuse and antimicrobial resistance are concerns.
Schedule X
- Drugs subject to particularly stringent controls.
- Prescription and storage requirements are stricter than ordinary prescription medicines.
Prelims Quick Revision
- Drugs Rules, 1945: regulatory framework for drugs and cosmetics.
- Draft notification: G.S.R. 791 (E).
- Proposed safeguard: CCTV surveillance at medical stores.
- Targeted categories: Schedule H, H1 and X.
- DCC: Drugs Consultative Committee.
- DTAB: Drugs Technical Advisory Board.
