CCTV at Medical Stores Proposed as Govt Tightens Regulatory Watch on Schedule H, H1 and X Drugs

Moneylife Digital Team 18 September 2026

Life

The Union ministry of health has proposed tighter regulatory oversight of the sale and distribution of Schedule H, H1 and X drugs, including mandatory CCTV surveillance at medical stores as an additional safeguard against unauthorised sales. The ministry said the proposed changes are intended to address concerns over unauthorised access to and sale of Schedule H, H1 and X medicines, particularly sales made without valid prescriptions.

The proposal has been made through draft gazette notification GSR791 (E), dated 8 September 2026, seeking amendments to the Drugs Rules, 1945. The move is aimed at improving the monitoring of prescription drugs and other regulated products.

If implemented, the CCTV requirement would add another layer of oversight at medical stores. The ministry said surveillance could improve transparency and accountability in the pharmaceutical supply chain while helping regulators monitor the handling and sale of these medicines.

The proposal has already gone through the drugs consultative committee (DCC) and the drugs technical advisory board (DTAB). The health ministry said the proposal was first considered by the DCC before being circulated among DTAB members for deliberation. Following its consideration, the DTAB recommended approval of the proposal.

The draft notification, however, is not yet a final rule. The ministry has invited objections and suggestions from stakeholders and members of the public before proceeding with the proposed amendment.

Under the existing regulatory framework, Schedule H, H1, and X medicines are subject to specific controls due to the risks associated with their use and distribution. The proposed surveillance mechanism is intended to strengthen enforcement at the point of dispensing medicines to consumers.

The move comes as the government has also taken recent regulatory measures concerning the safety of medicines for children.

Last month, the health ministry restricted the manufacture, sale, and distribution of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children under four years of age.

The ministry directed manufacturers of such formulations to prominently carry a warning stating: “Fixed dose combination shall not be used in children below four years of age.” The warning is required on the label, package insert and promotional material associated with the medicines.

The restriction was issued under Section 26A of the Drugs and Cosmetics Act, 1940, citing public health concerns, and took effect from the date of publication in the Official Gazette.

The latest proposal takes the government's regulatory focus beyond the composition and labelling of medicines to the way certain drugs are sold and monitored at retail outlets.

The ministry has asked those wishing to submit objections or suggestions on the draft amendment to write 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. Submissions can also be sent by email to [email protected].

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