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Kilitch Healthcare’s eyedrops recall in US: Spotlight back on good manufacturing practices 

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The recall of 27 eyedrop products from Kilitch Healthcare in the United States, makes it the second such incident from an Indian drugmaker in about 10 months.

The Mumbai-based company “voluntarily” recalled these products due to potential safety concerns after the US Food and Drug Administration’s investigators found unsanitary conditions. “For those patients who use these products, there is a potential risk of eye infections or related harm,” the USFDA said.

In February, Chennai’s Global Pharma Healthcare voluntarily recalled its Artificial Tears Lubricant Eyedrops, distributed by EzriCare LLC and Delsam Pharma. The action followed the US Centers for Disease Control and Prevention (CDC) investigations into drug-resistant infections possibly linked to contaminated eyedrops, they then said, pointing to adverse events including eye infections, permanent loss of vision and death.

The latest Kilitch Healthcare incident has put the spotlight back on good manufacturing practices, along with the need for good supply chain and storage practices as well, to keep such products sterile and contamination-free, say industry and eye specialists. And it comes against the backdrop of global incidents, including deaths, linked possibly to cough-syrups from India.

Good practices

In its latest communication on Kilitch Healthcare, the USFDA said, “These products are intended to be sterile. Ophthalmic drug products pose a potentially heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses.”

Dr Ajay Sharma, Founder and Chief Medical Director of Eye-Q super speciality eye hospitals, explains that fluid products, eyedrops, IV injections etc need sterile manufacturing. “In products like artificial tears, even the slightest bacterial presence can cause infection,” Sharma said. While sterile manufacturing is critical, so is the logistics involving transportaion and the temperature at which it is stored etc, he added. At the point of use by doctors, para-medics or consumers, he said, care needs to be taken to prevent contamination. Eye drops should not be used if its over a month old, he said, adding that it also needs to be kept in a cold place, possibly refrigerated.

Screen time

Several eyedrop products are sold over-the-counter, and are popular given the extended screen time in people’s lives, an industry insider said. It is unclear if Kilitch Healthcare’s recalled brands are sold in India. A response is awaited from the company to queries sent by businessline.

The USFDA note said Kilitch Healthcare had not received reports of adverse events related to this recall. The company was voluntarily recalling all lots of its eyedrops products listed by it, with expiry dates ranging from November, 2023 to September 2025, the USFDA said.



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