Schedule H, H1 and X drugs include prescription medicines used to treat conditions ranging from infections and chronic diseases to mental health conditions and other serious medical disorders. Their sale is subject to regulatory controls.
The proposal was initially deliberated by the Drugs Consultative Committee (DCC) and was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB). Following its consideration, the DTAB recommended approval of the proposal, the central government said in a statement.
“The proposed amendment seeks to address concerns relating to unauthorised access to and sale of Schedule H, H1 and X drugs and recommends mandatory CCTV surveillance at medical stores to enhance transparency and accountability,” the government said.
“Upon implementation, the proposed amendment is 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 government said.
The proposal has, however, raised concerns among pharmacy retailers over the cost and practical difficulties of putting such infrastructure in place.
The All India Organisation of Chemists & Druggists (AIOCD) has urged the government to reconsider the proposal, particularly its application to small and medium-sized chemists.
“Making six to eight CCTV cameras, DVR/NVR, storage, wiring, internet connectivity and maintenance mandatory could impose an additional financial burden of approximately ₹50,000 to ₹1 lakh or more on small and medium-sized chemists,” AIOCD President J.S. Shinde and General Secretary Rajiv Singhal said.
The organisation said the requirement could be particularly difficult for pharmacies in rural and remote areas. “In rural and remote areas, frequent power failures, poor internet connectivity and the non-availability of trained technicians make continuous CCTV recording difficult and impractical,” AIOCD said.
AIOCD has asked the government to provide the necessary infrastructure for installation and maintenance if CCTV surveillance is considered essential for public safety and regulatory monitoring. Alternatively, it has sought reconsideration of the mandatory requirement and adoption of a practical and proportionate mechanism.
The government has invited objections and suggestions from stakeholders and members of the public on the proposed amendment before taking it forward.