Industry Pushback Against India's Draft Bill on Medical Devices
India's medical device sector opposes a draft bill treating devices like drugs, citing potential harm to growth and innovation.
In India, the medical device industry and several healthcare groups have raised significant concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. The draft legislation, which seeks to overhaul an 86-year-old pharmaceutical law, has been criticized for its approach to regulating medical devices as if they were pharmaceutical products.
Concerns Over Regulatory Approach
Industry representatives argue that the draft bill does not acknowledge the fundamental differences between medical devices and pharmaceuticals. According to a letter addressed to the Union Health Minister, the bill's current language and structure could stifle manufacturing and innovation, undermining India's aspirations to become a global hub for medical devices. The letter, dated August 8, highlights that the bill continues to employ drug-centric terminology, such as "adulterated," "spurious," and "misbranded," which are not typically associated with engineering products like medical devices.
Unlike pharmaceuticals, medical devices are generally regulated through risk-based conformity assessments and quality management systems. The draft bill's inclusion of criminal penalties for regulatory lapses, such as labelling errors or documentation issues, has further alarmed industry stakeholders. These penalties, which could result in imprisonment of up to seven years, are seen as excessive, especially when no harm to patients occurs. This approach contrasts with international practices in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement is the norm.
Potential Impact on Investment and Innovation
The letter from industry associations warns that the draft bill, if enacted in its current form, could deter investment and discourage manufacturing within India. The associations emphasize the need for a regulatory framework that supports growth and innovation while maintaining patient safety. They contend that aligning India's regulatory practices more closely with international standards would better serve the country's burgeoning medical device sector.
The draft bill is currently undergoing inter-ministerial consultation, and stakeholders are hopeful that their feedback will lead to revisions that more accurately reflect the unique nature of medical devices. By advocating for a regulatory environment that distinguishes between pharmaceuticals and engineering products, industry leaders aim to foster a more conducive atmosphere for innovation and global competitiveness.
Calls for a Revised Approach
As discussions continue, the medical device industry reiterates its commitment to patient safety and quality assurance. However, it stresses the importance of regulatory measures that are proportionate and appropriate for the sector. The industry calls for a framework that emphasizes risk management and post-market surveillance rather than punitive measures, which could have unintended consequences for the sector's growth.
The outcome of this legislative process could have a profound impact on the future of India's medical device industry, influencing its ability to innovate and compete on the global stage. Stakeholders remain engaged in dialogue with the government, advocating for a balanced approach that recognizes the distinct characteristics of medical devices.