The Union Health Ministry has proposed making CCTV surveillance mandatory at licensed premises selling prescription drugs, as part of proposed amendments to the Drugs Rules, 1945.
The draft notification, G.S.R.
791(E), issued on September 8, proposes inserting a new provision in Rule 65 requiring the supply of drugs on the prescription of a registered medical practitioner, other than through wholesale dealing, to take place under a CCTV surveillance system installed and maintained at the licensed premises.
The recordings would have to be preserved for at least three months.
Govt. amends rules to strengthen regulation of drug formulations with high alcohol content The proposal follows deliberations by the Drugs Consultative Committee (DCC) and subsequent consideration by the Drugs Technical Advisory Board (DTAB).
The DCC had earlier recommended that CCTV cameras be made mandatory at medical stores and that they be positioned so that drug sales could be verified.
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Under the existing Drugs Rules, medicines covered by Schedules H, H1 and X cannot be sold at retail without a prescription from a registered medical practitioner, with additional record-keeping requirements for certain drugs.
The draft, however, is not yet a final rule.
The Ministry has invited objections and suggestions from affected persons and other stakeholders for 30 days from the date the Gazette was made available.
The proposed rules will be considered after the expiry of this period.
Health Ministry expands QR code-based drug traceability to vaccines, antimicrobials, and cancer medicines The Ministry has said submissions may be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, U-6, Work Hall-C Wing, First Floor, Kartavya Bhawan-1, New Delhi, or emailed to drugsdiv-mohfw@gov.in.
“The draft does not merely propose CCTV for Schedule H, H1 and X medicines by name.
Its wording is broader — it covers any drug supplied on a registered medical practitioner’s prescription, except wholesale transactions,” said a senior health official.