Sun Pharma eyedrop recall exposes gaps in enforcement, experts say

Rishi Agrawal, co-founder and CEO of TeamLease Regtech, called the current approach “patchwork-oriented.” He said the flow of information and enforcement is fragmented and poor. When food aggregators and airline companies can push real-time alerts to consumers, he argued, drug companies and regulators should be able to do the same for a product recall – a simple text message to patients’ phones.

Agrawal said whether a recall is voluntary or mandated by the drug regulator, there needs to be a transition period that accounts for financial impact and logistics. But if there is an immediate threat to health or life, the withdrawal should be immediate, he said. He also called for consequences when companies fail to comply.

The “classical problem is information asymmetry,” Agrawal said. He wants regulators and companies to have complete digital visibility into supply chains and recalls across the country. Such a system, he said, creates “regulatory memory” that would help identify fraudulent companies that resurface under a different name after being blacklisted.

Businessline reached out to the All India Ophthalmological Society and the Health Ministry to ask whether an alert had been issued on the 11 withdrawn eye drops. Neither had responded at the time of publication.

Sun Pharma said it is working closely with healthcare professionals, hospitals, and authorities, and has taken all necessary steps under applicable regulatory requirements. The company declined to comment further on the effectiveness of the recall.