Even as the government directives for the quality testing of medical devices that were recently notified as drugs are yet to materialise, the National Institute of Biologicals (NIB), Noida has announced its intentions to begin quality testing of all implantable medical devices for regulatory purposes.

The approvals from the institute may soon become a pre-condition for a marketing approval from the office of the Drugs Control General of India (DCGI). According to sources, NIB is to begin testing of medical devices for quality, efficacy and safety profile during the current year itself.

Dr V K Kashyap, director NIB told Pharmabiz that the institution, an autonomous institute established by the Ministry of Health and Family Welfare for providing regulatory R&D in biologicals, is to play a significant role in asserting the quality of all medical devices that are imported or manufactured for marketing in the country.

"We are currently testing 35 biologicals for quality standards. This would be increased to 200 within the next six months. We would also start testing medical devices, including a variety of implantables during the current year," Kashyap said.

Interestingly, there are about 2000 biologicals that are currently being marketed all over the world. While most of the products are available in India, the safety testing parameters are not completely developed for all kinds of devices. The current approvals, given after batch-wise testing, are carried out by various institutions spread across the country. With the active entry of NIB, most of the regulatory testing jobs are likely to come under a single organisation.

Responding to a Pharmabiz query, state drug controllers of various states informed that they are yet to begin the quality inspection activities related to medical devices.

"The quality approval should come from the central drug regulatory authority. The notification, declaring 10 types of medical devices as drugs also mention about a concurrent method of regulation. This means joint inspections by the central and state drug officials. We also need to know how they intend to do it. No guidelines have been issued yet," they explained.

Many of the state drug control authorities are of the opinion that they should confine themselves to the registration of dealers, manufacturers and importers of medical devices. The medical devices industry and trade are coming forward to get themselves registered, drug officials informed.