Delay in land allotment hits progress of TN's first medical devices testing lab

New Indian Express

22-04-2025

COIMBATORE: The state government is set to establish the first Medical Devices Testing Laboratory in Coimbatore district for Rs 29.67 crore. However, sources said the project is yet to commence due to delay in land identification process by the district administration.
The Medical Devices Rules, under the Drug and Cosmetics (D&C) Act, came into effect in January 2018, bringing medical devices under the broader umbrella of the Act. It required manufacturers, importers and sellers to obtain necessary permissions for their activities.
Testing medical devices at government-owned laboratories is also a part of the rules. However, the drug administration department in Tamil Nadu has not performed any tests on medical devices due to the lack of a specialised laboratory in the state. After long, the project was officially announced in December 2024. Health Minister Ma Subramanian officially announced the project during demands for grants, sources said.
Based on the proposal from the Director of Drugs Control, Tamil Nadu, the central government approved the plan of establishing a well-equipped NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratory for testing medical devices, including in-vitro diagnostics, exclusively in Coimbatore. In a Memorandum of Understanding (MoU) between the central and state government under the Strengthening of State Drug Regulatory System scheme, Rs 29.67 crore was allocated for the project in mid-2024-25, in a fund sharing ratio of 60:40 by the centre and the state, respectively.
Sources said there has been no progress in setting up the laboratory. "Considering the importance of the standard of medical devices, the central government introduced separate rules to them, and this mandates proper testing at laboratories. Even after the rule came into force, it could not be followed as there is no proper lab facility. While the establishment of the laboratory is expected to play a major role in testing medical devices across the state, the ongoing delay in land identification has raised concerns that the allocated funds might be returned as they remain unused," said sources.
"There are well-equipped laboratories for drugs in Chennai and Madurai. As we have medical device manufacturers in Coimbatore region, and it is also an industrial hub, we chose to establish the device testing laboratory here. This lab is to test class A and B category medical devices. We need around one acre, including 20,000 sqft for the laboratory. Once the Coimbatore district administration identifies the land, we can start work through the Public Works Department. We sent a letter to the Coimbatore district collector, and a communication through the health secretary. We hope to get the land allotment soon," said MN Sridhar, Director of Drugs Control.
Coimbatore District Collector Pavankumar G Giriyappanavar said, "We have shortlisted few parcels of lands, and will finalise it at the earliest as we are in the final stage of confirming the land."