Govt Strengthens Schedule Drugs Regulation, Recommends CCTV Surveillance at Medical Stores
Summarized by AI; it may make mistakes. Check important info
Summarized by AI; it may make mistakes. Check important info
The government has proposed amendments to strengthen regulatory oversight of Schedule H, H1 and X drugs, including a recommendation for CCTV surveillance at medical stores as an additional safety measure.
The Union Health Ministry proposed amendments to the Drugs Rules, 1945, through a draft gazette notification dated September 8. The move seeks to address concerns over the unauthorised access to and sale of these medicines without valid prescriptions.
CCTV surveillance proposed at medical stores
The proposed amendments are expected to strengthen monitoring of the sale and distribution of Schedule H, H1 and X drugs and help prevent their unauthorised sale.
“The proposed CCTV surveillance mechanism will also enhance transparency and accountability across the pharmaceutical supply chain, thereby strengthening safeguards for public health,” the Health Ministry said.
The proposal was initially discussed by the Drugs Consultative Committee (DCC) and subsequently circulated among members of the Drugs Technical Advisory Board (DTAB) for consideration. Following deliberations, the DTAB recommended approval of the proposal.
The ministry has invited objections and suggestions from stakeholders and members of the public regarding the draft amendments.
Restrictions on medicines for children
The development comes weeks after the government imposed restrictions on the manufacturing, sale and distribution of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.
Through a notification issued under Section 26A of the Drugs and Cosmetics Act, 1940, the Health Ministry mandated a warning stating that these medicines must not be used for children under four.
Manufacturers have been directed to display the warning—“Fixed Dose Combination shall not be used in children below four years of age”—on the product label, package insert and promotional literature.
The notification, issued in the interest of public health, came into effect from the date of its publication in the Official Gazette, according to the ministry.
