Medical Device Industry Opposes Drug-Style Regulation in Draft Bill

The medical device industry in India has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes regulating medical devices under the same framework as pharmaceuticals. Industry representatives argue this approach could stifle innovation and discourage investment, potentially hindering India's goal of becoming a global leader in medical device manufacturing.

Concerns Over Regulatory Approach

The draft bill has drawn criticism from a coalition of medical device manufacturers, healthcare providers, and patient safety groups. They have communicated their concerns to the Union Health Minister, emphasizing that medical devices should not be regulated as pharmaceuticals. The groups argue that the bill's language and penalties are more suited to drugs, neglecting the distinct nature of medical devices as engineering products.

Industry representatives highlighted that the bill's use of terms like "adulterated," "spurious," and "misbranded," along with its imposition of criminal penalties for regulatory deviations, is inappropriate for medical devices. They advocate for a regulatory framework based on risk assessment, quality management, and post-market surveillance, similar to international standards.

Potential Impact on Innovation and Investment

The draft bill proposes imprisonment of one to seven years for issues such as labeling errors and documentation lapses, even when no harm results. This approach is seen as punitive, contrasting with the administrative enforcement practices of regulatory bodies like the EU MDR, US FDA, and others.

Industry stakeholders warn that such stringent measures could deter investment and innovation in the sector. They argue that the proposed regulations do not provide the necessary foundation for growth and competition on a global scale. The letter to the health minister underscores the need for a regulatory system that recognizes the engineering and scientific distinctions between medical devices and pharmaceuticals.

Call for Rethink and Consultation

The draft bill, currently under inter-ministerial consultation, aims to replace the existing 86-year-old law governing pharmaceuticals in India. However, the medical device industry is urging a reconsideration of the draft, advocating for regulations that support the sector's unique characteristics and growth potential.

As India strives to position itself as a global hub for medical device manufacturing, industry leaders are pushing for a more tailored regulatory approach. They emphasize the importance of aligning with international best practices to foster innovation and attract investment in the sector.