CCTV proposed at medical stores for sale of prescription drugs

The Union Health Ministry has proposed new regulations that would require CCTV surveillance at licensed premises selling prescription drugs. These proposed changes would be made to the existing Drugs Rules, 1945, specifically in Rule 65. The draft notification, G.S.R. 791(E), was issued on September 8, 2020. The new provision would require that drugs dispensed on a registered medical practitioner's prescription, other than through wholesale dealing, must be supervised by a CCTV surveillance system installed and maintained at the licensed premises.

These recordings would need to be kept for a minimum of three months. The proposal emerged from discussions at the Drugs Consultative Committee (DCC), which then presented the matter to the Drugs Technical Advisory Board (DTAB). The DCC had previously recommended that CCTV cameras be made mandatory in medical stores, with the aim of enhancing oversight of the sale of prescription medicines and providing a method to verify transactions in cases of suspected unauthorized sales.

Currently, the sale of medicines under Schedules H, H1, and X requires a prescription from a registered medical practitioner, with additional record-keeping rules for certain drugs. However, this draft rule has not yet been finalized. The Ministry has opened a 30-day window for accepting objections and suggestions from affected individuals and other stakeholders following the publication of the draft in the Gazette.

The proposed rule is not limited to Schedule H, H1, and X medicines; it applies to any drug supplied on a registered medical practitioner's prescription, except for wholesale transactions. According to a senior health official, the draft rule's wording is more extensive than the name might suggest. The draft rules will be reviewed after the conclusion of the 30-day objection period.

Interested parties can submit their comments or suggestions to the Under Secretary (Drugs) at the Ministry of Health and Family Welfare or email them to drugsdiv-mohfw@gov.in. The Ministry emphasized that the draft rule applies broadly to any drug sold on a prescription basis, not just Schedule H, H1, and X medicines.