Medical Device Sector Criticizes Draft Bill for Pharma-Like Regulations
India's medical device industry opposes a draft bill equating devices with drugs, citing potential harm to innovation and investment.
The Indian medical device sector has voiced strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inappropriately classifies medical devices alongside pharmaceuticals. Industry representatives assert that such a classification could stifle innovation, deter investment, and impede the country's aspirations to become a global leader in medical device manufacturing.
Industry Concerns Over Regulatory Approach
Various associations, including those representing manufacturers and healthcare providers, have formally requested that the Union Health Ministry reconsider the draft bill. They argue that the bill's framework does not align with the unique nature of medical devices, which are fundamentally engineering products rather than pharmaceuticals. The associations have emphasized that the draft treats medical devices as an extension of pharmaceuticals, disregarding the distinct scientific and regulatory requirements of each sector.
The draft bill has raised alarms due to its use of drug-centric terminology, such as "adulterated," "spurious," and "misbranded." These terms, typically associated with pharmaceuticals, are applied to medical devices in the draft, which also imposes stringent criminal penalties for regulatory lapses. According to the industry, this approach fails to recognize the engineering nature of medical devices, where deviations are often technical rather than harmful.
Potential Impact on Innovation and Investment
Critics of the bill highlight the potential negative impact on the industry, including reduced manufacturing incentives and a chilling effect on innovation. The draft bill proposes imprisonment for periods ranging from one to seven years for offenses such as labelling errors, documentation issues, and licensing discrepancies, even when no actual harm results. This is in stark contrast to international practices, where administrative measures generally address such issues.
Internationally, regulatory bodies like the EU MDR, US FDA, and Japan PMDA employ risk-based conformity assessments and quality management systems to regulate medical devices. These systems focus on post-market surveillance and recalls rather than criminal penalties, a model that industry representatives argue is more appropriate for the medical device sector.
Calls for Policy Revisions
The associations' letter, dated August 8, underscores the need for a regulatory framework that supports growth and global competitiveness. They urge the government to develop policies that distinctly address the needs of the medical device sector, separate from those governing pharmaceuticals. Industry stakeholders are calling for a shift towards regulations that prioritize safety and efficacy through engineering-focused assessments rather than punitive measures.
As the draft bill undergoes inter-ministerial consultation, the medical device sector remains hopeful that the government will amend its approach to better reflect the unique characteristics and requirements of medical devices. By aligning with global standards, India could enhance its position as a hub for medical device manufacturing while ensuring patient safety and fostering innovation.