Mumbai: The state 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 raid, authorities froze Rs 1.26 crore worth of stock pending investigation.The stock was imported from Malaysia by Saachi Medic, which has units in Saki Naka and Bhiwandi, and sold to Mediearth Lifecare Pvt Ltd, which in turn sold them to govt hospitals at a time when its sterilization machine was malfunctioning.Abhay Pandey, president of the All Food and Drug Licence Holders, said both firms are being unfairly targeted.He said a day before the FDA raids, Mediearth had recalled the product after it was brought to its notice that the supply included non-sterilised gloves.“The company was expected to dispatch the order on urgent basis. Their sterilisation machine could not take the load and had started beeping towards the end of the bulk order. The client was unable to tell which was sterile and which wasn’t. There are chemical strips inside the boxes for pharmacies to be sure of sterility. The assumption was it would be flagged if the product was not sterile and recall would be issued accordingly,” said Pandey, who represents the companies as a lawyer.Pandey said only half the batch had reached the hospitals when a recall was ordered. On the other hand, FDA officials said no such recall order was shown to them at the time of the raids.The FDA also seized gloves valued at Rs 74.85 lakh from Saachi Medic’s Saki Naka godown for storing and selling them without a license. Pandey insisted that the products supplied to BMC hospitals were sterile goods, but he acknowledged they were stored and sold from the Saki Naka facility which lacked a sales license. He said, “rules changed in 2023, requiring a license even for sale of medical devices. My client’s only mistake here is that he did not possess that license.”
