Union Health Ministry Proposes Amendments to Drugs Rules, 1945

The Union Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, through a draft notification (G.S.R. 791(E)) dated 8 September 2026. The move aims to tighten regulatory control over how Schedule H, H1, and X drug categories that require valid prescriptions are sold and monitored across the country.

Mandatory CCTV surveillance proposed at medical stores

The centrepiece of the proposal is a requirement for retail medical stores to install CCTV cameras. Wholesalers, notably, are kept outside this requirement; the focus is squarely on the retail point of sale, where over-the-counter misuse of restricted drugs is most likely to happen. Stores would also need to retain the recorded footage for a minimum of three months, giving regulators a usable trail to check compliance whenever needed.

New Amendments to Drug Rules, 1945

Before reaching this stage, the proposal went through the Drugs Consultative Committee (DCC) for initial discussion and was then sent to the Drugs Technical Advisory Board (DTAB) for further review. The DTAB has since given its recommendation for approval. Now, the ministry has opened the draft up for public feedback, inviting objections and suggestions from stakeholders before it's finalised.

Target Medicines of New Amendments to Drug Rules, 1945

The rules are specifically aimed at Schedule H, H1, and X drug categories that include habit-forming and potentially dangerous medicines that can only legally be sold against a doctor's prescription. These are exactly the drugs most vulnerable to unauthorized access when oversight is weak.

Why the Government Proposed the New Amendments to Drug Rules, 1945

1. Prescription-only drugs: The core worry driving this proposal is simple: prescription-only drugs sometimes end up in the wrong hands without any prescription at all. CCTV surveillance is meant to close that gap, adding a visible layer of accountability across the pharmaceutical supply chain. 
2. Stopping illegal sales: Beyond curbing illegal sales, the government hopes this will make the entire retail medicine system more transparent and easier to monitor, ultimately protecting public health. For now, the proposal remains open for public and expert comment before it becomes a formal rule.