Tender process complete for TN's first medical devices testing lab

Sources said progress had been slow owing to delays in land identification, raising concerns that funds might be returned if unused.
Image used for representational purposes only.
Image used for representational purposes only.File Photo
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COIMBATORE: The health department has completed the tender process for Tamil Nadu's first medical devices testing laboratory, which will be set up in Coimbatore at an outlay of Rs 29.67 crore. Officials said work will begin this month.

Of the total allocation, Rs 8 crore will be used for construction, and the remaining amount will be set aside for infrastructure and equipment procurement. The laboratory will be set up on a one-acre plot inside the Coimbatore Medical College (CMC) campus on Avinashi Road.

The Medical Devices Rules, notified under the Drugs and Cosmetics Act, came into effect in January 2018. The rules mandate that manufacturers, importers and sellers obtain necessary permissions and that those medical devices be tested at government-owned laboratories. However, Tamil Nadu's drug administration department has not conducted any tests on medical devices due to the lack of a specialised laboratory. The project was officially announced in December 2024.

Based on a proposal from the director of Drugs Control, the centre approved setting up a NABL-accredited laboratory for testing medical devices, including in-vitro diagnostics, in Coimbatore. Under the 'Strengthening of State Drug Regulatory System' scheme, Rs 29.67 crore was allocated in mid-2024-25, with a 60:40 fund-sharing ratio between the centre and state.

Sources said progress had been slow owing to delays in land identification, raising concerns that funds might be returned if unused. "Considering the importance of device standards, the centre introduced separate rules mandating proper testing. However, without a lab, rules could not be enforced," a source said.

"There are well-equipped drug testing laboratories in Chennai and Madurai. Since Coimbatore is an industrial hub with several medical device manufacturers, we chose to establish the device testing laboratory here. The lab will test Class A and B category medical devices. We need around an acre, including 20,000 sq ft for the laboratory," an official said.

After several hurdles, the department identified one acre inside the CMC campus. In the final stage of the fund utilisation period, it received clearance from the Directorate of Medical Education to use the land. The tender process is complete and will be approved by the department once the new government is formed. Meanwhile, DTCP approval is under way. Construction is expected to begin within a month, sources said.

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