The government has decided to do away with clinical trials for medical devices that have been approved and marketed for at least two years in European Union countries.
The move, which is set to speed up the availability of such medical devices in India, was agreed in a recent meeting of the Drug Technical Advisory Board (DTAB), India’s top advisory body on drugs and medical devices.
The Union health ministry will soon issue a notification to this effect, formalizing the decision taken at this year’s June meeting.
“It is proposed to include EU in the provision specified under Rule 63(1) in the Medical Devices Rules, 2017 in respect of the waiver of clinical investigation," said the minutes of the meeting, which Mint has reviewed.
The matter was taken up during the meeting of India-EU sub-commission on trade held on 6 June, 2018. “The EU side pointed out that for the regulation of new products, the new regulations stated that clinical investigation may not be required to be submitted where the investigational medical device is approved by regulatory authorities of the US, the UK, Australia, Canada or Japan but does not include the EU. In the view of above, it is proposed to include EU," added the minutes.
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The Medical Device Rules allows for an exemption in cases where the device does not have its predicate device (a legally marketed device that is not subject to premarket approval) in India before it is sold or distributed in India but has been approved by the regulatory authority in the US, the UK, Australia, Canada or Japan.
The device should have been marketed in that country for at least two years, and the data of safety, performance and pharmacovigilance of the device should comply with the standards of India’s Central Licensing Authority. Also, additional clinical investigation should not be required for that device while granting the permission.
According to officials in the Central Drugs Standard Control Organisation (CDSCO), the proposal seeks to remove regulatory bottlenecks while ensuring the availability and increased access to state-of-the-art devices in the Indian market. 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," said a CDSCO official.
The medical device lobby, Association of Indian Medical Device Industry (AiMeD), criticized the government’s move.
“We regret to note that even after the serious incidents of failure of J&J orthopaedic implants, recall of bioresorbable stents by Abbott, failure of pelvic mesh implants and related serious adverse events, our regulators instead of tightening up regulations to protect Indian public and seek independent clinical evidence, wish to dilute regulations for importers. Why is CDSCO being partial to importers lobby? We can’t accept regulatory approvals by the US FDA and EU regulators and permit them market access in India. Overseas regulators are not reciprocally partial to Indian exporters so why is CDSCO wishing to bend over ministry of health supporting such moves to favour imports," said Rajiv Nath, forum coordinator, AiMeD.