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Mumbai: Kasturba Hospital‘s laboratory was testing medical devices without a licence for the past eight years, but has only now drawn action from the Food and Drug Administration (FDA).
FDA officials said an inspection of the hospital’s central analytical laboratory revealed the facility continued to test products such as gauze, sutures, cotton and bandages without regulatory clearance even after new rules came into force in 2017. Until then, the lab held an umbrella licence to test drugs and cosmetics, which also covered these devices.
These devices are supplied to BMC hospitals only after being tested for sterility, safety, and quality. While the hospital halted the activity in March, according to FDA, it is unclear whether alternative third-party testing was carried out, as hospital officials were unavailable for comment.
Nishigandha Pashte, a drug inspector with FDA’s Zone 1, said, “When rules changed, the hospital continued as before. They are now claiming they were unaware of the new regulations.”
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