Partner: Ashwin Sapra
This is a link enhanced version of the article that first appeared on PharmaBiz.
Trilegal, a leading law firm in the country now sees that the Union government’s proposed surveillance requirement by installing CCTV across all pharmacies will only partially prevent unauthorised sale of prescription drugs.
CCTV may provide useful retrospective evidence, but it does not verify the prescription, authenticate the prescriber, validate the quantity or establish that the correct medicine was dispensed. It should therefore complement not replace effective prescription verification and dispensing controls, said Ashwin Sapra, Partner-Corporate (Pharmaceuticals, Healthcare & Life Sciences), Trilegal.
On the legal and compliance obligations that could arise for pharmacies if the amendment is implemented, Sapra said that pharmacies would face obligations around installation, maintenance, recording and retention of footage, with potentially significant additional requirements once technical, storage, security and audit standards are prescribed. Therefore, the Union government’s draft notification should clearly define the scope and standards so that compliance is objectively determinable, he added.
Delving into the privacy, data retention, access and usage considerations around footage, Sapra said that CCTV installed in the pharmacy can reveal sensitive information about an individual’s medicines and treatment. “The final framework should therefore prescribe purpose limitation, authorised access, security, disclosure controls, retention and deletion, rather than merely mandating three-month retention. All said, patient privacy is utmost.”
No doubt, CCTV could provide corroborative evidence for regulatory investigations, but its evidentiary value depends on being capable of correlation with the prescription, dispensing and transaction records. The rules should also clearly define the scope of access to footage to avoid subjective or inconsistent enforcement. The extent to which drug inspectors can act needs to be expressly clarified. A regulation that sans limits of action is often misused, he said.
Practical challenges for pharmacies, particularly smaller establishments, in implementing and maintaining the proposed infrastructure will be there. We see compliance could impose significant costs for installation, storage, maintenance, power backup, replacement and data security, with a disproportionate impact on smaller pharmacies. A risk-based approach would better recognise differences in the nature, scale and risk profile of dispensing operations. Where regulation increases fiscal burden on business, compliance may take a backseat, pointed out Sapra.
Sapra observed that the draft framework requires greater clarity around implementation, responsibility and compliance standards. The rules should clearly define the drugs and premises covered; minimum CCTV specifications; responsibility for compliance; access, security and retention requirements; a protocol for technical failures; and the treatment of hospitals, institutional pharmacies, e-pharmacies and fulfilment centres. The objective should be an auditable chain linking prescription, dispensing, transaction and CCTV, rather than surveillance in isolation.
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