The Union Ministry of Health & Family Welfare has proposed amendments to the Drugs Rules, 1945, to enhance regulatory accountability for some prescription drugs and curb their unauthorized access and sale. One of the key proposals would be to implement CCTV surveillance at medical stores dealing with Schedule H, H1 and X drugs.
The proposed changes are intended to enhance the monitoring of prescription drug sales and to make pharmacies and other businesses working with drugs subject to stricter regulatory controls more accountable. The Drugs Consultative Committee (DCC) has considered the proposal, as well as the Drugs Technical Advisory Board (DTAB).
Schedule H, H1 and X medicines are subject to specific requirements under India’s drug regulatory framework because of greater control over their sale and distribution. The medicines are those that are only to be sold on a prescription or require more record-keeping and regulatory requirements.
Under the plan, CCTV surveillance would give regulators another way to monitor the activities at medical stores where prescription medicines are sold. The recorded footage could help in inspections and investigations into suspected violations of prescription medicines.
That comes at a time when the unauthorized sale and access of prescription drugs is still an issue. More aggressive monitoring at the retail level might help the authorities identify where medicines are given without the necessary prescriptions or where regulatory processes are not followed.
Mandatory surveillance could also create a more detailed record of transactions and activities going on at pharmacies. Prescription records and other documentation are already part of the regulatory framework for controlled categories of medicines, but CCTV footage could add another layer of oversight.
The proposal follows discussions in the country's statutory drug advisory system. The Drugs Consultative Committee considered the problem before it was discussed by members of the Drugs Technical Advisory Board, reflecting the government's desire to review the regulatory framework.
However, the proposed amendment is a regulatory proposal and should not be interpreted as an immediate nationwide requirement unless and until the necessary rule-making process is completed and the amendments are formally notified.
If implemented, pharmacy operators handling Schedule H, H1 and X drugs would face additional compliance duties with the installation and maintenance of surveillance systems. The rules would be expected to clarify key operational details, including the scope of establishments covered, surveillance requirements, storage of recordings and access to regulatory authorities.
The proposed policy could affect pharmacy owners and consumers. CCTV installation for pharmacies may be more expensive and infeasible. Surveillance footage could be evidence to support evidence during inspections or investigations; regulators might discover it. For consumers, the aim is to enhance controls over medicines that need to be monitored by medical personnel.
The government is more interested in making sure prescription medicines are supplied through the legitimate channels and in accordance with legal requirements. So the government will be able to enhance oversight of medical stores to reduce the number of unauthorized sales and therefore to comply with India's drug regulations.
The proposed CCTV requirement is part of a wider regulatory approach to strengthening monitoring of medicines covered under Schedule H, H1 and X. Further details will depend on the final amendments and notifications issued by the Ministry of Health & Family Welfare.
