The government on Thursday said it has proposed amendments to strengthen regulatory oversight over Schedule H, H1 and X drugs, along with recommending mandatory CCTV surveillance at medical stores as an additional regulatory safeguard. 

Health Ministry proposed amendments to the “Drugs Rules, 1945,” through a draft gazette notification dated September 8. The proposed amendment seeks to address concerns relating to unauthorised access to and sale of Schedule H, H1 and X drugs.

After implementation, the amendments are expected to help strengthen monitoring of the sale and distribution of Schedule H, H1 and X drugs and curb their unauthorised access and sale without valid prescriptions.

“The proposed CCTV surveillance mechanism will also enhance transparency and accountability across the pharmaceutical supply chain, thereby strengthening safeguards for public health,” said Health Ministry.

The proposal was initially deliberated upon by the Drugs Consultative Committee (DCC) and was subsequently circulated among the members of the Drugs Technical Advisory Board (DTAB) for deliberation.

Following consideration of the proposal, the DTAB recommended its approval.

The Ministry has invited objections and suggestions from stakeholders and members of the public on the proposed amendment.

Last month, the government imposed restrictions on the manufacturing, sale and distribution of all fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.

Health Ministry, in a notification, mandated a clear warning that these medicines shall not be used in children below four years of age, in a significant step to safeguard the health and safety of young children.

The government directed manufacturers to clearly 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 associated with these formulations.

The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and is effective from the date of its publication in the Official Gazette, said the ministry.