In a strategic development, experts from the National Institute of Health (NIH) recently visited the Gujarat Food and Drug Control Administration (FDCA)'s office to examine the proposal for setting up the country’s first government biocompatibility and medical device testing lab in the state, a pet project of the FDCA. The main purpose of this visit was to explore and study the feasibility of the proposal submitted by the state drug regulator.

This move comes in the wake of persistent follow-up by the Gujarat FDCA to the Engineering Export Promotion Council (EEPC), urging them to sanction a budgetary allocation of Rs.15 crore for the same. The state drug regulator had in fact sent a strong representation to the Centre two weeks back urging them to consider the proposal, prompting the government to take this action.

This move by the Centre stands as a huge boost to the proposal as it is understood that EEPC, the trade promotion council under the commerce ministry constituted to aid the growth of the Indian engineering sector like medical devices is seriously deliberating over this matter.

Dr H G Koshia, commissioner of Gujarat FDCA informed that the meeting with the experts from the NIA team, which was headed by Dr Jitendra Sharma went exceedingly well. “They were impressed by our vision to establish this testing lab dedicated for the medical device sector, a much needed factor for the growth of the industry and gave us positive feedback on the same. Keeping in view of dire need in the country to have a government lab for the medical devices, we are positive that our demands will get through at the Centre. Especially since it goes with the Prime Minister’s ‘Make In India' campaign and aims to strengthen the industry further. We are confident that based on our proposal and their observations the Centre would certainly sanction the requisite funds to set up this lab within the food and drug testing facility in Baroda, which is located in the middle of the thriving industrial belt,” Dr Koshia added.

Once the budget is sanctioned by the Centre, the state regulatory body plans to utilise the same to develop the infrastructure as required, to acquire high tech equipments for testing and get trained manpower for the same. Incidentally, India does not have a biocompatibility and medical device-testing lab today, in spite of it being one of the growing sectors in the healthcare.

As of now domestic manufacturers are forced to send their devices to other countries like Singapore to get their products tested before marketing it. International testing agencies do the biocompatibility study for them, generating the data and filing the reports for the manufacturers, a process which is not only time consuming but also very costly for domestic manufacturers.