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Shardul Nautiyal, Mumbai January 30 , 2018
The Union health ministry's ambitious medical device testing lab project at Vadodara in Gujarat which was supposed to be implemented last year under the ASIDE scheme of the commerce ministry has been stalled due to inordinate delay in its implementation.

Now the commerce ministry has asked the Central Government Procurement agency HLL to send a fresh proposal for again sanctioning India’s first medical device testing lab at Vadodara.

The Union health ministry had appointed HLL for procurement of equipment through a global tendering process under the ASIDE scheme last year. The scheme, however, got closed and the money was not disbursed on time as HLL could not procure equipment as per stipulated timelines, according to a senior official associated with the development.

Department of Commerce was administering Assistance to States for Infrastructure Development of Exports (ASIDE) Scheme since 2002-03, with the objective to involve the states in the export by providing assistance to the state governments for creating appropriate infrastructure for the development and growth of exports. The outlay of the scheme had two components i.e. 80% of the funds (state component) and 20% (central component).

Recommended and promoted by the union commerce ministry, the country’s flagship project was developed in partnership with union health ministry with technical support from healthcare technology division of National Health Systems Resource Centre (NHSRC), a technical support institution under the Union health ministry.

The Gujarat Food and Drug Control Administration (FDCA) and NHSRC had also jointly sent a report asking HLL for the equipment and infrastructure required for the lab project but could not get the desired response.

Gujarat government also followed with 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 was signed between the Government of India and Gujarat Government last year.

Ministry of Commerce had sanctioned an amount of Rs.15 crore for the flagship project for which the site at drug testing lab at Vadodara was also approved based on an audit. 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 was suggested at an Engineering Export Promotion Council (EEPC) Meet at Ahmedabad 2 years ago which realised the need for setting up a dedicated medical device testing lab. 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.

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