The proposal for inclusion of the EU to this list will be taken up at the next meeting of the Drugs Technical Authority Board (DTAB), India’s highest advisory body on drugs under the drug regulator, a government document said.
ET has seen a copy of the document.
If approved, the government will amend Rule 63(1) of the Medical Devices Rules, 2017, for inclusion of the EU.
The matter has been under consideration since 2018, when, during the meeting of the India-EU sub-commission on trade, the EU officials said 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 the regulatory authorities of the US, UK, Australia, Canada or Japan, but did not include the EU, as per Rule 63(1).
The proposal was sent to the health ministry for amendment to Rule 63(1) in 2021. However, it was referred back to the Central Drugs Standard Control Organisation (CDSCO) for critical review in the context of updated rules and recent notifications.
The ministry also asked for deliberations in consultation with DTAB for a fresh proposal.
Rajiv Nath , forum coordinator, Association of Indian Medical Devices Industry, suggested that if India needs to give EU-based manufacturers any waiver or fast-track regulatory approval, then the country should negotiate its trade agreement with the EU on a reciprocal basis rather than simply conceding and amending its Medical Devices Rules.
“India needs to seek reciprocal acceptance by the EU of fast-track regulatory approval for CDSCO-licensed or QCI’s ICMED-certified Indian manufacturers too,” Nath said. “The EU and CDSCO and QCI can jointly do cross-mapping and verification of provisions at each other’s regulations and effectiveness of audit controls before arriving at an MRA (mutual regulatory agreement).”
