Ingredients News - Gujarat FDCA writes to health ministry to accelerate process of setting up much awaited medical device testing lab at Vadodara


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Gujarat FDCA writes to health ministry to accelerate process of setting up much awaited medical device testing lab at Vadodara

Shardul Nautiyal, Mumbai September 27 , 2017

The Gujarat Food and Drug Control Administration (FDCA) has written to the union health ministry to accelerate the process of setting up the much awaited medical device testing lab at Vadodara in Gujarat, MoU for which has recently been signed between the Government of India and Gujarat Government.

The drug testing lab project, which was originally recommended by the Union commerce ministry, will be developed with technical support from Healthcare Technology Division of National Health Systems Resource Centre (NHSRC) of the union health ministry.

“Ministry of Commerce has also sanctioned an amount of Rs.15 crore for the flagship project for which the site at drug testing lab at Vadodara has already been approved based on a recently concluded audit. The Union health ministry has also appointed HLL, a central government agency for procurement of equipment through a global tendering process,” according to an official associated with the development.

Gujarat FDCA in the past had also sent a proposal to HLL for urgent procurement of testing equipment towards setting up the testing lab.

Setting up of a dedicated medical device testing lab in the country would be a boon for the Indian manufacturers to help adhere to compliance towards patient safety as the country today lacks in registering and thereby reporting adverse events due to faulty medical devices at the point of care.

Proposal for setting up a testing lab is the culmination of an Engineering Export Promotion Council (EEPC) Meet at Ahmedabad one and a half years ago which realised the need for setting up a dedicated medical device testing lab to ensure quality assurance of medical devices manufactured in the country.

Till date, products are usually sent to foreign countries for testing due to lack of a reliable and advanced medical device testing facility in the country. Though the government plans to set up two medical device testing labs in the country at Vadodara in Gujarat and another at Noida subject to getting approvals, medical device testing lab in Gujarat would be the first and the only dedicated biomaterials and implants testing lab in the country. The lab at Noida will be set up primarily to test electrical and electronic medical devices in the country.

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