Union health and family welfare ministry has proposed amendments to the Drugs Rules, 1945, to mandate medical stores to install CCTV cameras to monitor the unauthorised sale of drugs, which must only be sold with a prescription from a registered medical practitioner. This comes amid complaints about pharmacists selling prescription drugs over the counter.
In a statement, the ministry said it has proposed amendments to the Drugs Rules, 1945, through a Draft Gazette Notification on September 8 to strengthen regulatory oversight over Schedule H, H1 and X drugs.
Schedule H drugs require a valid prescription for sale. Schedule H1 is a sub-category, where the sale must be well-documented. Schedule X includes habit-forming, psychotropic, and narcotic substances.
Deep Dive
What are the proposed amendments to the Drugs Rules, 1945 regarding CCTV installation in medical stores?
Why is the Ministry of Health and Family Welfare advocating for CCTV surveillance in pharmacies?
How can the public provide feedback on the proposed amendment to the Drugs Rules?
The statement said the proposed amendment seeks to address concerns relating to unauthorised access to and sale of Schedule H, H1 and X drugs. It added that it recommends mandatory CCTV surveillance at medical stores as an additional regulatory safeguard.
The statement said the Drugs Consultative Committee (DCC) first deliberated the proposal. It was subsequently circulated among members of the Drugs Technical Advisory Board (DTAB) for consideration. The DTAB has recommended approval of the proposal.
The ministry expects the proposed measure will help curb the unauthorised sale and access to such medicines and improve transparency and accountability in the pharmaceutical supply chain. It said the proposed amendment is part of efforts to strengthen regulatory oversight and safeguards for public health.
{{/usCountry}}The ministry expects the proposed measure will help curb the unauthorised sale and access to such medicines and improve transparency and accountability in the pharmaceutical supply chain. It said the proposed amendment is part of efforts to strengthen regulatory oversight and safeguards for public health.
{{/usCountry}}“Upon implementation, the proposed amendment is expected to help strengthen monitoring of the sale and distribution of Schedule H, H1 and X drugs and curb their unauthorized access and sale without valid prescriptions. The proposed CCTV surveillance mechanism will also enhance transparency and accountability across the pharmaceutical supply chain, thereby strengthening safeguards for public health,” said the statement.
The ministry has invited objections and suggestions on the proposed amendment. “The comments can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare or emailed to drugsdiv-mohfw@gov.in,” said the ministry in its draft notification.