MUMBAI, Oct. 3 -- For more than eight years, the civic administration potentially risked the health and lives of patients as it did not have a licence to test medical devices, drugs and other supplies at its four major hospitals and 16 peripheral hospitals. Quality checks had been conducted at the BMC's lone central analytical laboratory at Kasturba Hospital, but the centre ceased testing medical devices after an FDA crackdown in March. The FDA found that the lab did not have the licence to conduct the tests as it had ignored changes in regulations issued in 2017. As mandated - although without a licence - the laboratory used to conduct random sampling of stocks supplied to civic hospitals. Device types tested include stents and balloons used in heart procedures, body implants, sutures, urine bags, syringes, bandages, gloves and plaster of paris, among many other items. Although testing had already been taking place, the ministry of health and family welfare introduced the Medical Devices Rules in 2017, which laid down enhanced parameters for testing and quality control. The rules also increased the scope of devices tested and regulated under them. The BMC was now required to procure a new licence under the MDR, 2017, without which it was not authorised to conduct testing. "The new rules standardised the testing process and increased the types of items that needed to be tested for quality. This is essential in the interest of public health," said Abhay Pandey, national president of the All Food and Drug License Holders Foundation. But, in 2024, a medical supplier brought a shocking truth to light. He informed the Central Licensing Authority that the BMC did not possess the licence to conduct the testing, a situation that had persisted for eight years. After inspections in March, the Food and Drugs Administration (FDA) of Maharashtra issued a notice to Kasturba Hospital and its testing centre. After this, the laboratory stopped testing medical devices but continued to test drugs as these did not require an additional licence. An FDA officer told HT that the hospital had claimed it wasn't aware that it needed a new licence after 2017. "They are in the process of acquiring one now," said the FDA official. A visit by HT to Kasturba Hospital revealed the dire condition of the laboratory. The doors were cracked and broken, and conditions were far from sanitary, raising questions about the quality of tests it had been conducting. Pandey alleged that the BMC is risking the lives of patients. For example, bad quality sutures can cause stitches to break; sometimes implants in the body can lead to contamination; bandages not bleached properly can lead to infections, he said. Meanwhile, BMC officials said they are in the process of procuring the mandatory licence. "We will restart testing at our laboratory once we get it," said a senior BMC health official. Tushar Jagtap, Maharashtra convenor of Healing hands unity panel and health activist, said, "This is a matter of concern as there is now centralised regulation on the quality of materials supplied, especially consumables. Maharashtra has a history of spurious drugs and consumables, which has had adverse effects on patients. Since they know that they have to acquire the licence now, BMC should direct those who supply the materials to conduct rigorous quality testing."...