Getting prescription medicines from a pharmacy could soon involve another layer of monitoring, as the Union Health Ministry has proposed making CCTV surveillance mandatory at licensed premises that supply medicines prescribed by registered medical practitioners.
The proposal is part of a draft amendment to the Drugs Rules, 1945. Issued through G.S.R. 791(E) on September 8, the draft proposes inserting a new sub-rule, 2A, under Rule 65.
The move comes amid concerns over the “unauthorised access to and sale of Schedule H, H1 and X drugs”.
The draft states that the supply of any drug against a prescription from a registered medical practitioner, other than through wholesale dealing, must take place under a CCTV system installed and maintained at the licensed premises.
If the proposal is notified in its current form, pharmacies would have to ensure that prescription-based sales are covered by surveillance cameras. The recordings would also have to be retained for at least three months.
The proposed system is intended to strengthen monitoring of prescription medicine sales and provide a verifiable record of transactions at the point where medicines are supplied. It comes amid concerns over the unauthorised sale and access of prescription drugs.
While the ministry cited concerns involving these categories, the proposed CCTV requirement refers to any drug supplied on the prescription of a registered medical practitioner, as long as it is not a wholesale transaction.
This could have wider implications for retail pharmacies if the provision is finalised without changes.
Schedule H, H1 and X medicines already have specific controls under the Drugs Rules. These include prescription requirements and record-keeping provisions for certain categories. The proposed CCTV system would add another layer of monitoring at the retail level.
For pharmacies, the measure would also bring additional compliance requirements. They would need to install and maintain cameras and preserve recordings for the specified period. The technical and operational requirements will depend on the final rules and any directions issued after the consultation process.
The proposal follows discussions among expert committees under the country’s apex drug regulator, CDSCO, on using CCTV systems to track and trace the movement and sale of Narcotic Drugs and Psychotropic Substances (NDPS) medicines.
The objective is to create a reliable record of sales at retail medical stores and strengthen safeguards already governing prescription medicines.
The issue was discussed at a meeting two months ago in August with the experts under the drug regulator. The meeting examined the possible use of CCTV cameras to track and trace NDPS drugs across the supply chain after it was noted that the drugs were being misused.
A Joint Action Plan was also proposed by the National Commission for Protection of Child Rights (NCPCR), which had raised concerns over the unregulated sale of certain medicines through retail pharmacies and called for stronger surveillance and information systems.
A separate expert body had also considered the proposal in April. The Drugs Consultative Committee (DCC) agreed that CCTV cameras at medical stores could be made mandatory through an amendment to the Drugs Rules.
The committee also stressed that cameras should be positioned appropriately within the premises so that sales could be verified.
