Medical Device Industry Opposes India's Draft Regulatory Bill
India's medical device industry opposes a draft bill equating devices with drugs, citing potential harm to innovation and investment.
The medical device sector in India is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices in the same manner as pharmaceuticals. Industry representatives argue that such an approach could stifle innovation and deter investment, ultimately hindering India's potential to become a global leader in medical device manufacturing.
Industry Concerns Over Regulatory Approach
Several associations representing manufacturers, traders, healthcare providers, and patient safety groups have expressed their disapproval of the draft bill. In a letter to the Union Health Minister dated August 8, these groups highlighted that medical devices should not be treated as pharmaceuticals due to their distinct scientific and engineering characteristics. They warned that the draft bill's provisions could discourage manufacturing and investment, posing a significant barrier to the growth of India's medical device industry.
The draft bill is currently under inter-ministerial review. It proposes criminal penalties, including imprisonment for regulatory lapses related to medical devices, a move that industry leaders argue is inconsistent with international practices. The letter points out that global regulatory bodies like the EU MDR, US FDA, Japan's PMDA, UK's MHRA, and Australia's TGA focus on administrative enforcement rather than criminalization.
Impact on Innovation and Global Competitiveness
The draft bill's language, which includes terms such as "adulterated," "spurious," and "misbranded," is seen as drug-centric and inappropriate for the regulation of engineering-based products like medical devices. The industry argues that such terminology could lead to unnecessary criminalization of minor regulatory deviations, potentially stifling innovation and discouraging new entrants into the market.
Industry leaders emphasize that medical devices are typically regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, rather than punitive measures. They caution that the proposed bill does not provide the necessary regulatory framework to support innovation and global competitiveness in the medical devices sector.
A Call for Rethink and Collaboration
The medical device industry is urging the government to reconsider the draft bill's approach and engage in collaborative discussions to develop a regulatory framework that acknowledges the unique nature of medical devices. By establishing clear and supportive regulations, India could enhance its position as a hub for medical device innovation and manufacturing.
The pushback from the industry underscores the critical need for regulations that foster growth and innovation while ensuring patient safety. As the draft bill undergoes further consultation, stakeholders hope for revisions that align with international best practices and support the burgeoning medical device sector in India.