Insight
‘Reassessing India’s Medical Device Recall Framework: Regulatory Gaps and the Case for Reform’, published on Mondaq.
Partner, Pradnesh Warke along with Associates Pragna Yenduri and Tanay Jha have recently authored an article titled, ‘Reassessing India’s Medical Device Recall Framework: Regulatory Gaps and the Case for Reform’.
India’s medical device sector is expanding rapidly, but its post-market recall framework remains underdeveloped. This article analyses key regulatory gaps under the Medical Device Rules, 2017, particularly the absence of enforceable recall timelines and comprehensive adverse event reporting obligations.
Referring to the ASR hip implant episode involving Johnson & Johnson Pvt. Ltd., the paper highlights systemic challenges in recall governance and compares India’s framework with global practices adopted by the U.S. Food and Drug Administration and Australia’s Therapeutic Goods Administration.
The authors propose a binding, time-bound recall regime with structured reporting and regulatory oversight to strengthen patient safety and industry accountability.
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