Why Health Ministry has proposed CCTV surveillance at medical stores for prescription drugs

The proposed amendment is intended to prevent the unauthorised access to and sale of Schedule H, H1 and X drugs without valid prescriptions.

The Union Health Ministry has proposed mandatory CCTV surveillance at medical stores to prevent the unauthorised sale and access of Schedule H, H1 and X drugs without valid prescriptions, while strengthening monitoring of how these medicines are sold and distributed at the retail level.

These categories include medicines that are subject to stricter controls and can only be sold in accordance with the prescription requirements prescribed under the Drugs Rules. (Representative Image)

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.

Deep Dive

What types of drugs fall under Schedule H, H1, and X?

Why is the Health Ministry implementing mandatory CCTV at medical stores?

How will the proposed CCTV surveillance improve pharmaceutical safety?

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What are Schedule H, H1 and X drugs?

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.

Why has the Health Ministry proposed CCTV surveillance?

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 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.

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.

What happens next?

The proposed amendment is part of efforts to strengthen regulatory oversight and safeguards for public health, the ministry said.

The ministry has invited objections and suggestions from stakeholders and members of the public on the proposed amendment. The feedback will be considered as part of the process before the proposed changes are finalised.

Comments and suggestions can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or emailed to [drugsdiv-mohfw@gov.in](mailto:drugsdiv-mohfw@gov.in).

The draft notification was issued on September 8, according to the ministry.