14:I[94367,["/_next/static/immutable/chunks/4370mg0uq-myq.js","/_next/static/immutable/chunks/0q7ni_ir0mogv.js","/_next/static/immutable/chunks/0q9_4lzwjwc3f.js","/_next/static/immutable/chunks/1p8rnjckwz-06.js","/_next/static/immutable/chunks/3zikwth1q5z_-.js","/_next/static/immutable/chunks/0eigul57_x91p.js","/_next/static/immutable/chunks/3r0kxtkfnobr8.js","/_next/static/immutable/chunks/260mvqou7a4l3.js","/_next/static/immutable/chunks/14bkwvgoktej3.js"],"NewsDetailPage"] 15:T1010,

The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, to strengthen monitoring of medicines classified under Schedule H, H1 and X. The proposal, issued through draft Gazette Notification G.S.R. 791(E) dated September 8, 2026, includes mandatory CCTV surveillance at medical stores as an additional regulatory measure.

The proposed changes are aimed at addressing concerns related to the unauthorised sale and access of these prescription medicines. Under the existing regulatory framework, Schedule H and Schedule X medicines are required to be sold only against prescriptions from registered medical practitioners, while Schedule H1 medicines are subject to additional record-keeping and prescription-monitoring requirements

The draft amendment proposes mandatory CCTV surveillance at medical stores to improve transparency and accountability in the retail sale of Schedule H, H1 and X medicines. The surveillance mechanism is intended to provide an additional layer of oversight over the dispensing and sale of these medicines. The move could also help regulatory authorities monitor compliance and investigate instances involving unauthorised access or sale without a valid prescription.

Drugs categorised under Schedule H need a prescription from a registered medical practitioner to be sold through retail outlets. Drugs that are listed under Schedule H1 are more tightly controlled than the other drugs in Schedule H. In addition to the requirement of a prescription, the process of supplying these drugs requires the maintenance of a document that contains information related to the purchaser, prescriber, drug name, and quantity of drug supplied. There is a requirement to maintain these records for a period of three years and make them available for inspection. Drugs under the category of Schedule X require a prescription as well as strict record maintenance by traders. Earlier, the government took strict action when it came to individual drugs under Schedule H1. For instance, pregabalin was changed from Schedule H to H1 in May 2026 after the government learned that it was improperly used and sold.

As stated by the Ministry, the Drugs Consultative Committee (DCC) made an initial deliberation on the proposal and asked the Drugs Technical Advisory Board (DTAB) for further consideration. As a result of the DTAB's recommendation, the proposal was approved. Thus, if the amendment is executed, CCTV surveillance will be added to the regulations pertaining to the trade and distribution of Scheduled H, H1, and X drugs. This initiative is part of larger plans to improve the monitoring of pharmaceutical supply. In the past, QR codes were introduced in 2026 for the purposes of drug tracking.

The Ministry has invited objections and suggestions from stakeholders and members of the public on the proposed amendment. The draft is therefore a proposal at this stage, and the final regulatory requirements may depend on the consultation process and subsequent government action.

If implemented in its proposed form, the CCTV requirement would provide regulators with an additional mechanism for monitoring retail medicine sales while complementing existing prescription, record-keeping and licensing requirements.

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