FDA Seizes Unsterilised Gloves Supplied From Bhiwandi and Saki Naka Units
The state Food and Drug Administration (FDA) has raided a Palghar-based manufacturer and frozen Rs 1.26 crore worth of stock after detecting unsterilised surgical gloves, falsely labeled as 'sterile', being supplied to government hospitals. The gloves were imported from Malaysia by Saachi Medic, which operates units in Bhiwandi and Saki Naka, before being distributed to major state-run medical colleges including JJ Hospital and St George.
The FDA launched the crackdown following concerns over potential infection and health risks to patients and healthcare workers. The non-sterile medical gloves had been sold to Mediearth Lifecare Pvt Ltd, which then supplied them to the government hospitals while its own sterilisation machinery was malfunctioning.
In addition to the primary seizure, the FDA confiscated gloves valued at Rs 74.85 lakh from Saachi Medic’s godown in Saki Naka for storing and selling medical devices without a license.
Abhay Pandey, president of the All Food and Drug Licence Holders and legal representative for the firms, defended the companies, claiming they are being unfairly targeted. According to Pandey, Mediearth had initiated a recall of the product a day before the FDA conducted its raids, after discovering that non-sterilised gloves were mixed into the urgent dispatch.
Pandey explained that the company was under pressure to complete a bulk order on an urgent basis. During the process, the sterilisation machine could not handle the load and began beeping toward the end of the run. Because the client could not distinguish which gloves were sterile, they assumed any issues would be flagged by pharmacies using internal chemical indicators, prompting a recall if necessary.
According to the defense, only half of the batch had actually reached the hospitals before the recall was ordered. However, FDA officials stated that no evidence of a recall order was presented to them at the time of the raids.
Regarding the unlicensed Saki Naka godown, Pandey admitted that the facility lacked a sales license, attributing the lapse to a rule change in 2023 that mandated licenses for selling medical devices. He asserted that the gloves supplied to BMC hospitals from that batch were sterile, and that the lack of a license was the company's only error.
