FDA freezes stock after unsterilised surgical gloves are supplied to hospitals
The state Food and Drug Administration (FDA) has raided a manufacturer for supplying unsterilised surgical gloves falsely labeled as "sterile" to state-run medical colleges, with part of the supply chain linked to a facility in Bhiwandi. Following the enforcement action, authorities froze stock worth Rs 1.26 crore pending a full investigation into the contamination risk posed to patients and healthcare workers.
The gloves were supplied to major government medical colleges, including JJ Hospital and St George.
According to the FDA, the surgical gloves were imported from Malaysia by Saachi Medic, a company with operational units in Bhiwandi and Saki Naka. The gloves were then sold to Mediearth Lifecare Pvt Ltd, which distributed them to the state-run hospitals. The distribution took place while Mediearth's sterilisation machinery was malfunctioning.
Abhay Pandey, president of the All Food and Drug Licence Holders, spoke on behalf of the companies as their lawyer and argued that both firms are being unfairly targeted. Pandey stated that Mediearth had already started recalling the products a day before the FDA conducted its raids, after discovering that unsterilised gloves were mixed into the supply.
Pandey explained that the company was rushing to dispatch an urgent bulk order. The sterilisation machine could not handle the load and began beeping towards the end of the process, leaving the operators unable to distinguish which boxes were sterile. He added that only half of the batch had actually reached the hospitals before the recall was ordered.
FDA officials, however, stated that no evidence of a recall order was shown to them during their raids.
In addition to the main seizure, the FDA confiscated gloves valued at Rs 74.85 lakh from Saachi Medic’s Saki Naka godown for storing and selling items without a license. Pandey acknowledged the lack of a license, citing a 2023 rule change requiring licenses for medical devices, but maintained those specific goods were sterile.
