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Gujarat FDCA gets Rs 14 crore to set up med device testing lab

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The first-of-its-kind medical device testing lab in the country will be commissioned by end of the year

The Ministry of Commerce and Industry, Government of India through Engineering Export Promotion Council India (EEPC) has sanctioned Rs 14 crore to set up a medical device testing laboratory at Gujarat Food and Drugs Control Administration (FDCA), Gandhinagar.

Giving more details, Dr Hemant Koshia, Commissioner, Food & Drugs Control Administration says, “Almost two months back, experts from the Ministry of Health and Welfare along with Dr. Jitendra Sharma, Sr Consultant, NHSRC, MoHFW, GOI, and Director, WHO Collaborating Centre for Priority Medical Devices & Health Technology Policy, visited and inspected our lab. We received positive feedback from them on this visit. The authorities involved in this project from the state as well as the Centre are working towards signing an MoU to set up the lab at Gujarat FDCA and I am expecting the lab to be commissioned by the end of this year.”

The proposed medical device testing lab in Gujarat aims to help curb the malpractices and use of substandard medical devices across the country. Koshia informs, “At present, not a single medical device testing lab exists in India. Companies need to go to Singapore or other developed countries for such medical device testing facilities. This takes a lot of time as well as money. With the help of this lab, the industry will save approximately Rs 250 crore in fees for any kind of quality test of medical devices. So, annually the country will save this huge sum and offer much affordable devices.”

Gujarat FDCA was the first state Food and Drug Laboratory to receive the National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation and also the first to start e-Governance to initiate online issuance of sales and manufacturing licenses.

Presently, the CDSCO website lists 253 approved hi-tech medical device companies in India, of which Gujarat has the largest share (135) followed by Haryana (24), Uttar Pradesh (14) and Maharashtra (12).

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