Eleven medical device industry associations have written to Union Health Minister J P Nadda seeking separate legislation for regulating medical devices, days after the government circulated a draft Drugs, Medical Devices and Cosmetics Bill for industry consultations. According to reports from Business Standard, in its final submission, a prominent domestic medical device group stated that the 2026 draft bill could not be supported in its current form, describing it as 'pharma-centric, criminalisation heavy and misaligned with global norms'. The opposition comes as medtech firms in the US are also expressing concerns about regulatory frameworks, with industry groups like Advamed supporting the latest Medical Device User Fee Amendments (MDUFA VI) while emphasizing the need for clearer communication and more consistent reviews.
The associations have argued that medical devices require a regulatory framework distinct from drugs, given differences in their design, manufacturing, risk classification, technology and life cycle. As reported by Business Standard, Rajiv Nath, forum coordinator for the Association of Indian Medical Device Industry (AiMeD), explained that the draft bill continued to use drug-centric terminology such as 'adulterated' and 'spurious', while applying pharma-style criminalisation to engineering deviations. The current framework could discourage manufacturing as it differs from global medtech standards such as the European Union's Medical Device Regulation (EU MDR) and those of the United States Food and Drug Administration (USFDA). In the US context, patient groups are calling for more emphasis on postmarket safety rather than just premarket review, with advocates like National Center for Health Research emphasizing the importance of representation in clinical trials for people with chronic disabilities.
According to a copy of the draft bill seen by Business Standard, an instance of technical non-conformity by medical device manufacturers can lead to cessation orders, criminal proceedings and imprisonment ranging from six months to seven years. Nath emphasized that there needs to be 'risk-proportional and engineering-aligned regulation', with penalties, licensing, surveillance and enforcement based on risk class and actual potential of harm. He noted that misbranding for devices could simply mean an incorrect font size, symbol or unique device identification (UDI) placement, highlighting the need for more nuanced regulatory approach. In the US context, the latest MDUFA VI agreement includes higher fees for overseas firms and hiring transparency requirements, with the total package coming out to about $580 million per year, roughly 1.5% above baseline.
The associations have sought the constitution of a new committee comprising engineering experts, clinicians, biomedical specialists, industry representatives and patient safety groups to advise on the enactment of a separate medical devices Act aligned with internationally recognised practices. As reported by Business Standard, they have also sought the establishment of an autonomous national medical devices regulatory authority on the lines of the Telecom Regulatory Authority of India (Trai), with clear oversight over state regulators and conformity assessment bodies. This proposed structure aims to provide more specialized and engineering-focused regulatory oversight for the medical device sector. In the US context, the Total Product Lifecycle Advisory Program (TAP) will become a full-fledged program with refined scope, providing early and frequent communications with the FDA for innovative medical devices and helping device firms provide evidence that payers seek.
