The Maharashtra Food and Drug Administration (FDA) conducted a raid on a Palghar-based manufacturer accused of supplying unsterilised surgical gloves falsely labeled as 'sterile' to state-run medical colleges, including JJ Hospital and St George. Authorities froze stock valued at Rs 1.26 crore pending further investigation.
Details of the Raid
The gloves were imported from Malaysia by Saachi Medic, which operates units in Saki Naka and Bhiwandi. The company sold them to Mediearth Lifecare Pvt Ltd, which subsequently supplied them to government hospitals while its sterilization machine was malfunctioning. The FDA also seized gloves worth Rs 74.85 lakh from Saachi Medic's Saki Naka godown for storing and selling them without a license.
Company's Defense
Abhay Pandey, president of the All Food and Drug Licence Holders and legal representative for both firms, argued that they are being unfairly targeted. He stated that a day before the FDA raids, Mediearth had recalled the product after being informed that the supply included non-sterilised gloves. Pandey explained that the company was required to dispatch the order urgently, and the sterilization machine could not handle the load, beeping towards the end of the bulk order. He added that chemical strips inside the boxes allow pharmacies to verify sterility, and the assumption was that any non-sterile product would be flagged and recalled accordingly.
FDA's Response
FDA officials, however, claimed that no recall order was presented to them at the time of the raids. Pandey acknowledged that the products supplied to BMC hospitals were sterile but admitted they were stored and sold from the Saki Naka facility, which lacked a sales license. He noted that rules changed in 2023, requiring a license for the sale of medical devices, and his client's only mistake was not possessing that license.
