Why in the News
The Ministry of Health and Family Welfare has proposed amendments to Rule 44 and Rule 63 of the Medical Devices Rules, 2017, adding the European Union to the list of jurisdictions whose regulatory approval India recognises for faster market entry. The Medical Devices Rules, 2017 currently grant an expedited licensing route in India to devices already approved by a short list of recognised foreign regulators, such as the US Food and Drug Administration. Adding the European Union’s regulatory approval to that recognised list extends the fast-track route to a much larger set of globally marketed devices.
What do Rule 44 and Rule 63 currently govern?
- Rule 44, predicate device and approval-based licensing: Rule 44 of the Medical Devices Rules, 2017 sets out the conditions under which a device already approved in a recognised foreign jurisdiction can secure an Indian manufacturing or import licence through a faster review, rather than a full fresh evaluation.
- Rule 63, licensing timelines and reliance on foreign approval: Rule 63 governs the timelines and documentary requirements for import licences, with reliance on foreign regulatory approval used to compress India’s own review period for devices from recognised jurisdictions.
- Currently recognised jurisdictions are limited: The existing fast-track list includes major regulators such as the US Food and Drug Administration, but has not included the European Union’s regulatory framework, requiring EU-approved devices to go through India’s standard, longer review.
Why add the European Union to the recognised list?
- The EU covers a large share of globally marketed devices: A significant share of medical devices sold worldwide first secure approval under the European Union’s regulatory framework, so recognising EU approval widens the pool of devices eligible for India’s fast-track route considerably.
- Reduces duplicate testing for already-approved devices: Recognising EU approval avoids re-running clinical and safety evaluations in India for a device that has already cleared a comparably rigorous regulatory process abroad.
- Intended to speed access to newer medical technology: A faster licensing route is expected to bring newer diagnostic and treatment devices to the Indian market sooner than the standard review timeline would allow.
Conclusion
The proposed amendments to Rule 44 and Rule 63 extend India’s fast-track medical device licensing route to European Union-approved devices, alongside the jurisdictions already recognised. The amendments are at the proposal stage, with the next step being their formal notification under the Medical Devices Rules, 2017.
Back2Basics: Medical Devices Rules, 2017
- Notified under the Drugs and Cosmetics Act, 1940, the Medical Devices Rules, 2017 created a dedicated regulatory framework for medical devices, distinct from the drug-licensing framework they had earlier been regulated under.
- Classify devices by risk into four classes, A to D, with review stringency rising with the device’s risk class.
- Are administered by the Central Drugs Standard Control Organisation, the national regulator for drugs and medical devices.
- Recognise approval from specified foreign regulators to allow an expedited licensing route for devices already cleared in those jurisdictions.
Matching Previous Year Question
“[2015, GS2, 12 marks] For achieving the desired objectives, it is necessary to ensure that the regulatory institutions remain independent and autonomous. Discuss in the light of the
experiences in recent past.”
