New Delhi: The government has proposed to do away with clinical trials for in-vitro diagnostic (IVD) devices that have been approved and marketed for at least two years in the UK, US, Australia, Canada, and Japan, with the aim of speeding up availability of such devices in India.

The Union health ministry will now come out with the notification to this effect, following a meeting in May of the Drug Technical Advisory Board (DTAB) at which the board agreed to the proposal to amend the provisions of the medical devices rules for waiver of clinical performance evaluation of IVDs.

IVDs include all blood testing techniques, tests that can detect diseases, conditions or infections for major conditions such as HIV, HBV (Hepatitis B), HCV (Hepatitis C).

“The board deliberated the matter and agreed to the proposal to amend the provisions in Rule 64 making it identical for waiver of clinical performance evaluation of in-vitro diagnostic medical devices in line with waiver given for medical devices under Rule 63 of the Medical Device Rules," said the minutes of the meeting, which Mint has reviewed.

According to senior officials in the Central Drug Standard Control Organization (CDSCO), the new proposal is an effort to provide foreign device manufacturers increased access to India’s huge medical device market.

“The new rules seek to remove regulatory bottlenecks to make in India, facilitate ease of doing business while ensuring availability of better medical devices for patient care and safety. Hence it was proposed to exempt IVDs from the clinical trial requirements," said an official, requesting anonymity.

Medical device experts believe that the move will help importers to a large extent as the exemption of trials would also mean accelerating approval of state-of-the-art devices, which can land in the country in four to six weeks.

However, questions are being raised about the government’s motive. “We welcome the steps taken to ease regulatory approval for IVD on line of medical devices. However, the question is whether the US, Japan and EU (European Union) will give similar reciprocal advantage to Indian exporters and waive off need for clinical evaluation if such devices are sold in India for two years? Regulation is not only about patients safety. It is also about parity. Indian regulators are seeking to ease business mainly for imported devices but are they negotiating with the EU and US FDA regulators on our behalf? That is the moot question." said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry.

Medical devices under local rules are classified based on associated risks, into Class A (low risk), Class B (low moderate risk), Class C (moderate high risk) and Class D (high risk). The manufacturers of medical devices are required to meet risk proportionate regulatory requirements that have been specified in the rules and are based on best international practices.

As of now all medical devices that fall under regulation have to undergo single or multiple clinical trials to prove their performance and quality in comparison to products currently available in the market. “Conduct of clinical investigations while following the international practices is conducted in a manner that ensures objectives of patient safety and welfare and discovery of new medical devices," added another official.

Currently, 462 medical devices and 250 IVD medical devices have been allocated a risk class.

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