To encourage medical device sector in the country, the Gujarat Food & Drugs Control Administration (FDCA) recently made a representation to the Centre urging them to sanction a budgetary allocation of Rs. 15 crore for setting up the country’s first government biocompatibility and medical device testing lab.

It is understood that Engineering Export Promotion Council (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.

Gujarat FDCA plans to set up this lab within the food and drug testing facility in Baroda. In fact, they have already identified a suitable location within the building, which is located in the middle of the thriving industrial belt. Once the requisite budget is sanctioned by the Centre, the state regulatory body plans to utilize the same to develop the infrastructure as required, acquire high tech equipment’s for testing and get trained manpower for the same.

Incidentally, India does not have a biocompatibility and medical device testing lab in the country today, in spite of it being one of the growing sector in the healthcare. Dr Koshia, commissioner of Gujarat FDCA informed that as of now domestic manufacturers are forced to send in 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.

“We have decided to embark on this project keeping in mind the interest of the medical device manufacturers, who are paying hefty sum for their products to be tested by international testing agencies. This move will not only give an affordable option for the manufactures but will also instill confidence among the stakeholders as well. 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.”

He added that the if things go as planned, then the state regulatory body plans to start the operations of the country’s first compact and high tech lab by end of this year.