FDA freezes Rs 1.26 crore of unsterilised medical gloves supplied to hospitals
The Food and Drug Administration (FDA) has raided a Palghar-based manufacturer for supplying unsterilised surgical gloves falsely labeled as "sterile" to state-run medical colleges, including JJ Hospital and St George. Following the action, authorities froze stock worth Rs 1.26 crore pending an investigation into the supply chain, which includes a storage unit in Bhiwandi.
The gloves were originally imported from Malaysia by Saachi Medic, a firm with units in Saki Naka and Bhiwandi. Saachi Medic sold the gloves to Mediearth Lifecare Pvt Ltd, which then distributed them to government hospitals. The supply occurred during a period when Mediearth's sterilisation machine was malfunctioning.
Abhay Pandey, president of the All Food and Drug Licence Holders, defended both companies, stating that they are being unfairly targeted. According to Pandey, Mediearth had initiated a recall of the product a day before the FDA raids after learning that non-sterilised gloves were included in the supply.
Pandey explained that Mediearth was under pressure to dispatch the order on an urgent basis. The company's sterilisation machine could not handle the load and began beeping near the end of the bulk order. Because the client could not immediately identify which gloves were sterile, the company assumed any non-sterile products would be flagged by pharmacies using internal chemical strips, prompting a recall.
Pandey stated that only half of the batch had reached the hospitals when the recall was ordered. However, FDA officials stated that no such recall order was presented to them during their raids.
In a related action, the FDA seized gloves valued at Rs 74.85 lakh from Saachi Medic’s godown in Saki Naka for storing and selling medical devices without a license. Pandey acknowledged that the Saki Naka facility lacked the sales license required under rules updated in 2023, but maintained that the goods supplied from there to BMC hospitals were sterile.
