In order to sell prescription drugs, outlets at pharmacies and other licensed retail premises will need CCTV surveillance, as the central government proposes a new requirement to make prescription drug sales verifiable.
As per a draft issued by the Ministry of Health and Family Welfare on September 8, the supply of any drug made on the prescription of a registered medical practitioner, and wholesale retailing, will have to take place under a CCTV surveillance system installed and maintained at the licensed premises.
Under the proposed rules, the CCTV recordings of the outlet must be preserved for a minimum of three months.
As per sources, the proposed measure is aimed at curbing the unauthorised sale of prescription medicines over the counter, strengthening monitoring and improving accountability in drug dispensing.
The move comes against the backdrop of medicines being given to children without appropriate medical supervision.
The draft seeks to amend Rule 65 of the Drugs Rules, 1945, by inserting a new sub-rule.
The Gazette states that the supply of any drug prescribed by a registered medical practitioner, except through wholesale dealing, must take place under a closed-circuit television surveillance system installed and maintained at the licensed premises.
In practical terms, the proposal could create a visual record of prescription drug dispensing at pharmacies and other licensed retail premises. In this way, the regulators could have greater traceability when checking whether prescription medicine was supplied against a valid prescription and investigating suspected violations.
Wholesale dealers are specifically excluded from the proposed CCTV requirement.
As per government sources, the proposal is intended to address the unauthorised sale of prescription medications, including medicines that should not be supplied without a valid prescription.
It has pointed out instances when cough syrup and other medicines intended for adults are given to children despite differences in formulation, doses and safety.
Earlier this year, the Centre revised the drug rules to remove the exemption that had allowed cough syrup to be supplied without a prescription.
The Centre has invited objections and suggestions on the proposed amendment.
The draft will be considered after 30 days the draft rules before public. The notification also mentions the proposed rules will come into force only from a date specified by the government at the time of their final publication in the official gazette.