Published Sep 17, 2026 | 3:44 PM ⚊ Updated Sep 17, 2026 | 3:45 PM
Drugs. (iStock)
Synopsis: Schedule H, H1 and X medicines are subject to varying degrees of regulatory control, with their sale and dispensing governed by prescription and record-keeping requirements. The proposed CCTV requirement would add a surveillance layer at the retail point where these medicines are dispensed to consumers.
The Union Ministry of Health and Family Welfare has proposed making CCTV surveillance mandatory at medical stores as part of tighter controls on the sale and distribution of Schedule H, H1 and X drugs, all of which cannot be sold without a prescription.
The proposal, issued through Draft Gazette Notification G.S.R. 791 (E) dated September 8, 2026, seeks to strengthen regulatory oversight of medicines that are subject to prescription and other restrictions under the Drugs Rules, 1945.
The proposed amendment comes amid concerns over the unauthorised access to and sale of Schedule H, H1 and X drugs. Mandatory CCTV surveillance at medical stores has been proposed as an additional safeguard to monitor transactions and improve accountability.
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Under India’s Drugs and Cosmetics Rules, 1945, Schedule H, H1 and X are categories of medicines subject to prescription and additional regulatory controls. Schedule H drugs are prescription medicines that generally cannot be sold without a prescription from a registered medical practitioner.
Schedule H1 drugs face tighter controls, with pharmacies required to maintain a separate record of their sale, including details of the patient, prescriber, drug and quantity, and preserve these records for three years. These controls are intended to regulate medicines such as certain antibiotics, anti-TB drugs and medicines with potential for misuse.
Schedule X drugs are subject to stricter controls than Schedule H and H1 drugs, including requirements around prescriptions, record-keeping and storage. Retail sale generally requires a prescription in duplicate, with one copy retained by the pharmacist.
The three categories therefore represent medicines for which the government has prescribed varying degrees of oversight, particularly to prevent unauthorised sale, misuse and diversion.
The proposal for CCTV was first deliberated upon by the Drugs Consultative Committee (DCC) and was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB) for consideration.
Following its deliberation, the DTAB recommended approval of the proposal, according to the ministry.
If implemented, the amendment would provide regulators with an additional mechanism to monitor the sale and distribution of Schedule H, H1 and X medicines and help detect instances where such drugs are sold without valid prescriptions.
The ministry said the proposed surveillance mechanism would also improve transparency and accountability in the pharmaceutical supply chain and strengthen safeguards for public health.
The draft notification has now been opened for objections and suggestions from stakeholders and members of the public. The ministry has given a period of 30 days for submitting feedback on the proposed changes.
Objections and suggestions can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi-110001.
Stakeholders can also email their submissions to drugsdiv-mohfw@gov.in.
The proposed changes will be considered by the government after examining the objections and suggestions received during the consultation period. The draft notification does not by itself bring the proposed requirements into force.
(Edited by Sumavarsha, with inputs from Sumit Jha)
