The Union Health Ministry has announced a proposal for mandatory CCTV surveillance in medical stores. This initiative aims to curb the unauthorized sale of Schedule H, H1, and X drugs, which are often sold without valid prescriptions. The move is part of a broader effort to enhance monitoring of the sale and distribution of these controlled medications at the retail level.
Schedule H drugs are medicines that can be sold only against a valid prescription from a registered medical practitioner. Schedule H1 is a sub-category of prescription medicines for which the sale is subject to additional documentation and record-keeping requirements. Schedule X covers drugs that are subject to particularly stringent controls, including certain habit-forming, psychotropic and narcotic substances. The proposed CCTV requirement is intended to provide an additional safeguard for monitoring the sale of these medicines and checking whether medical stores are complying with the prescription and record-keeping requirements. The mandatory CCTV surveillance is being proposed as an additional regulatory measure to strengthen monitoring of the sale and distribution of Schedule H, H1 and X drugs at medical stores. The proposal was first deliberated by the Drugs Consultative Committee (DCC) and was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB) for consideration. Following deliberation, the DTAB recommended approval of the proposal. With CCTV surveillance, the government is seeking to create an additional mechanism for monitoring the handling and sale of medicines covered under these schedules at the retail level. The proposed measure would supplement the existing regulatory safeguards governing prescription drugs. The proposed requirement would give regulators an additional means of monitoring compliance with the rules governing the sale of prescription medicines at medical stores. It would also strengthen oversight of how Schedule H, H1 and X drugs are handled and sold at the point where they reach consumers.
The proposal is part of amendments to the Drugs Rules, 1945, aimed at strengthening regulatory oversight of prescription drugs and adding another safeguard to ensure medical stores comply with existing requirements governing their sale. In a statement, the ministry said it has proposed the amendments through a Draft Gazette Notification dated September 8 to strengthen regulatory oversight over Schedule H, H1 and X drugs.
The ministry said the measure is expected to help curb the unauthorised sale and access to such medicines, while also improving transparency and accountability in the pharmaceutical supply chain.
Public Feedback Invited on Health Regulatory Amendment
The Ministry of Health and Family Welfare has proposed an amendment aimed at enhancing regulatory oversight for public health. Stakeholders and the general public are encouraged to share their objections and suggestions regarding the proposed changes. Feedback will be considered before finalizing the amendment.
Comments can be directed to the Under Secretary (Drugs) at the ministry or emailed to [email protected]. The draft notification was released on September 8.
