Government proposes tighter controls on Schedule H, H1 and X drugs

The government has proposed tighter regulatory controls on the sale and distribution of Schedule H, H1 and X drugs, including mandatory CCTV surveillance at medical stores, to prevent their unauthorised access and sale without valid prescriptions.

Ministry of Health and Family Welfare has proposed amendments to the Drugs Rules, 1945, through a draft gazette notification dated 8 September. The proposed changes are aimed at strengthening oversight of medicines classified under Schedules H, H1 and X and improving monitoring across the pharmaceutical supply chain.

Under the proposed framework, CCTV surveillance at medical stores would serve as an additional regulatory safeguard, with the government stating that the measure would improve transparency and accountability while helping curb unauthorised sales.

The proposal was initially 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 review, the DTAB recommended approval of the proposal.

The health ministry has invited objections and suggestions from stakeholders and members of the public on the proposed amendments.

The move comes amid other recent regulatory measures aimed at strengthening drug safety. Last month, the government restricted the manufacture, sale and distribution of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.

The ministry directed manufacturers to prominently display the warning — “Fixed Dose Combination shall not be used in children below four years of age” — on the label, package insert and promotional literature accompanying such medicines.

The restriction was imposed under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and came into effect from the date of its publication in the Official Gazette.

With IANS inputs