FDA Raids Firms Over Unsterilised Surgical Gloves Supplied to State Hospitals
The state Food and Drug Administration (FDA) has raided a Palghar-based manufacturer and frozen Rs 1.26 crore worth of stock after detecting that unsterilised surgical gloves, falsely labeled as 'sterile', were supplied to state-run medical colleges. The supply chain of the unsterilised medical gloves involved Saachi Medic, which operates packaging and storage units in Bhiwandi and Saki Naka, and Mediearth Lifecare Pvt Ltd, which distributed the gloves to government hospitals.
The contaminated gloves were distributed to major government medical facilities, including JJ Hospital and St George. According to reports, the distribution occurred at a time when Mediearth Lifecare's sterilisation machine was malfunctioning. The machine reportedly could not handle the load of the bulk order and began beeping toward the end of the process, leaving the company unable to distinguish between sterilised and unsterilised gloves.
Abhay Pandey, president of the All Food and Drug Licence Holders and the legal representative for the firms, defended the companies, arguing they are being unfairly targeted. Pandey stated that Mediearth had initiated a recall of the product a day before the FDA raids occurred, once they realized non-sterilised gloves were part of the shipment.
Pandey explained that only half of the batch had actually reached the hospitals before the recall was issued. He added that the company assumed hospital pharmacies would use the chemical strips inside the boxes to verify sterility and flag any issues. However, FDA officials disputed this claim, stating that no such recall order was presented to them at the time of their raids.
In a related action, the FDA also seized gloves valued at Rs 74.85 lakh from Saachi Medic's Saki Naka godown for storing and selling medical devices without a proper license. Pandey acknowledged that the Saki Naka facility lacked the necessary sales license due to a regulatory change in 2023, but maintained that the goods supplied from there to BMC hospitals were sterile.
