Maharashtra FDA seizes medical devices, gloves worth ₹2.17 cr in crackdown on irregularities
Thane/Palghar: The Maharashtra Food and Drug Administration has seized medical devices and medicine stocks worth more than ₹2.17 crore as part of a crackdown in Mumbai, Bhiwandi, Thane, and Palghar, an official said on Friday.
Maharashtra FDA seizes medical devices, gloves worth ₹2.17 cr in crackdown on irregularities
The extensive enforcement campaign was initiated under the Drugs and Cosmetics Act 1940 and Medical Devices Rules 2017, he said.
It also led to the uncovering of a racket involving non-sterile gloves being labelled as sterile for supply to hospitals and medical colleges, the official informed.
“A specialized team inspected a medical device manufacturing facility in Bhiwandi, which revealed critical violations of manufacturing protocols, including absence of Quality Management Systems, Standard Operating Procedures , and Plant Master File. Surgical glove stock worth ₹9.88 lakh has been seized, while the firm was issued a show-cause notice,” he said.
The FDA also raided Saachi Medic in Saki Naka in Mumbai, which was operating without registration and had illegally imported millions of surgical gloves from Malaysia and stored them without a licence, he said.
“These non-sterile gloves were being supplied to units in Bhiwandi and Wada for packaging, labelling, and subsequent unauthorized sale. FDA teams seized surgical gloves worth ₹74.85 lakh, with records indicating supplies had already been made to Mumbai civic hospitals,” he said.
A raid at Mediearth Lifecare Pvt. Ltd in Wada in Palghar revealed the firm purchased non-sterile gloves and supplied these to government hospitals and medical colleges as sterile without any processing, an FDA release said.
At the Wada facility, the FDA prohibited a stock of non-sterile bandage cloths, rolled bandages, and absorbent cotton gauges worth ₹1.26 crore, all marked with ‘Government of Maharashtra supply – Not for Sale’, it said.
Additionally, allopathic medicines worth ₹6.17 lakh, bearing the same government supply text, were seized as the facility lacked a valid wholesale drug licence, it said.
FDA Commissioner Tukaram Mundhe advised doctors, hospitals, and medical colleges to purchase medical devices and surgical gloves exclusively from licensed, authorized manufacturers.
“Buyers must meticulously verify license numbers, batch details, manufacturing/expiry dates, and compliance with the Medical Devices Rules, 2017, while avoiding damaged packaging,” he said.
Given the gravity of the threat to patients’ lives, the FDA is formally notifying the State Health Department and Brihanmumbai Municipal Corporation for further action as verification of seized records continues, he said.
