Mumbai: Kasturba Hospital’s laboratory was testing medical devices without a license 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 that 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 license to test drugs and cosmetics, which also covered these devices.
These medical devices are supplied to BMC-run hospitals only after being tested for sterility, safety, and quality. While the hospital halted the activity in March, according to the FDA, it remains unclear whether alternative third-party testing was carried out, as hospital officials were unavailable for comment.
Nishigandha Pashte, a drug inspector with the FDA’s Zone 1, said, “When the rules changed, the hospital continued as before. They are now claiming they were unaware of the new regulations.”
The inspection was carried out with the Central Licensing Authority after complaints from one of the medical device suppliers. Pashte said Kasturba Hospital is now trying to restart the service by applying for a new license but is awaiting approval from its higher authorities.
