The recent voluntary withdrawal of Sun Pharmaceutical’s eye drops has raised concerns on the implementation and enforcement of recalled products – as some retailers and regulatory officials claim they did not have information on the recall.
Sun had initiated a voluntary withdrawal mid-July on 11 eye drops as a “precautionary measure”, it said in a letter to partners. A month on, businessline was able to procure a couple of the recalled products, for example, from local chemists.
Drug regulatory experts call for a realtime system to communicate product recalls across the supply chain, and consumers, in public interest. Pointing to the “patchy” implementation of the recall, and subsequent enforcement, they said, regulatory action should ensure the recall is effective.
Udaya Bhaskar, with the All India Drugs Control Officers’ Confederation, points out that ophthalmologists had flagged concerns involving certain eye drops in June, followed by the company’s voluntary recall in July.
In the absence of a public alert by regulatory authorities, Bhaskar told businessline, if a company takes back a product for some reason, “regulators should promptly identify the underlying reasons and take regulatory action on the respective manufacturing unit,” ensuring that the product is recalled from the end-user.
In June, opthalmologists had cautioned against using certain batches of “Predmet” eye drops, due to “microbiological findings”.
Businessline reached out to the All India Opthalmological Society on their advisory, and the Health Ministry to check if an alert had been issued on the 11 withdrawn eye drops. A response is awaited.
Sun Pharma told the correspondent, “At Sun, we take patient safety very seriously. Out of an abundance of caution, we have voluntarily withdrawn some ophthalmic products and informed the central and state regulatory authority. We are working closely with healthcare professionals, hospitals and concerned authorities and have taken all necessary steps in accordance with applicable regulatory requirements. A helpline has been established to address queries from patients and healthcare professionals.”
Realtime recall messaging
Pointing to the “patchwork-oriented approach”, Rishi Agrawal, Co-founder and Chief Executive at TeamLease Regtech, says, “the flow of information ..and the flow of enforcement is very fragmented and poor.” When food aggregators and airline companies are able to inform consumers in real-time, he says, surely drug companies and regulatory authorities should also be able to communicate a recall across the system, and to end-users, through messages on their phones, for example.
Whether the recall is voluntary or mandated by the drug regulator, there needs to be a transition period taking into account the financial impact, logistics etc, he says, adding that the withdrawal should be immediate if there is an immediate threat to health or life. And, there should also be consequences for transgressions by companies, he says.
The “classical problem is information asymmetry”, he says, calling on regulatory authorities and companies to have complet digital visibility on supply chains and recalls – anywhere in the country. Such a system creates “regulatory memory”, he says, helping regulators identify fraudulent companies that may resurface in a different avatar, despite being blaclisted earlier.