Maharashtra FDA Uncovers ₹2.17 Crore Medical Device Supply Violations Linked To Government Hospitals; Surgical Gloves, Gauze Seized

Mumbai, June 5: In a shocking revelation, the Maharashtra Food and Drug Administration (FDA) has uncovered alleged illegal supply of surgical gloves, bandages, absorbent cotton gauze, and medicines worth over Rs 2.17 crore to government hospitals, including BMC-run hospitals, during raids conducted in Mumbai, Bhiwandi, and Palghar, officials said on Thursday.

Violations in medical device storage and supply

According to FDA officials, the raids exposed large-scale violations involving storage, packaging, and supply of medical devices without valid licences and mandatory quality standards under the Drugs and Cosmetics Act, 1940, and Medical Devices Rules, 2017.

Officials also suspect that non-sterile gloves were falsely labelled and supplied as sterile surgical gloves to government hospitals and medical colleges.

FDA officials said surgical gloves worth Rs 74.85 lakh were seized from M/s Saachi Medic in Sakinaka after the firm was allegedly found storing and selling imported gloves without valid licences.

“The company had imported surgical gloves from Malaysia and supplied them to units in Bhiwandi and Wada for packaging and labelling before distribution,” an official said.

Documents recovered during the inspection allegedly revealed that the products had been supplied to Brihanmumbai Municipal Corporation (BMC) hospitals, officials added.

Major violations at Bhiwandi and Palghar units

During subsequent inspections at a Bhiwandi-based manufacturing unit linked to the firm, FDA teams found major violations of Medical Devices Rules, 2017, including absence of a Quality Management System, Standard Operating Procedures (SOPs), and Plant Master File, officials said. Surgical gloves worth Rs 9.88 lakh were subsequently restricted, and production at the facility was ordered to be stopped.

In another major raid at M/s Mediarth Lifecare Pvt Ltd in Wada, Palghar, FDA officials alleged that the company procured non-sterile gloves and supplied them as sterile products to government hospitals despite sterilisation equipment being non-functional.

“The company owner has given a written admission during the inquiry,” an FDA official claimed.

Officials said the FDA also found non-sterile bandage cloth, rolled bandages, and absorbent cotton gauze labelled “Government of Maharashtra (MMGPA) Supply – Not for Sale.” The stock worth Rs 1.26 crore has been prohibited from sale and distribution.

Additionally, allopathic medicines worth Rs 6.17 lakh were seized from the premises for allegedly being stored without a valid wholesale drug licence. Further investigation and legal action are underway, officials said.

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Guidance for hospitals and medical colleges

“The matter is being communicated to the State Health Department and the Brihanmumbai Municipal Corporation (BMC). We appeal to all hospitals, doctors, and medical colleges to procure medical devices and medicines only from authorised vendors and mandatorily verify licence numbers, batch numbers, manufacturing dates, and expiry dates before purchase,” FDA officials said.

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