Indian Medical Device Industry Opposes Draft Bill on Regulatory Grounds

The Indian medical device industry, alongside healthcare groups, is voicing strong opposition to the proposed Drugs, Medical Devices, and Cosmetics Bill, 2026. They argue that the bill's approach to regulating medical devices as pharmaceuticals could severely impact innovation, manufacturing, and investment within the sector.

Concerns Over Regulatory Approach

Industry representatives, including manufacturers, traders, and patient safety groups, have communicated their concerns to the Union Health Minister. They contend that the draft bill fails to recognize the distinct nature of medical devices compared to pharmaceuticals. The bill's language and proposed penalties, they argue, are more suited to drug regulation, ignoring the engineering and scientific differences inherent to medical devices.

The draft bill proposes criminal penalties, including imprisonment of up to seven years, for regulatory lapses such as labeling errors and documentation mistakes. Industry advocates warn that such measures, which are not standard practice in regions like the EU, US, Japan, UK, or Australia, could discourage investment and stifle the growth of India's medical device sector.

Industry's Call for a Distinct Regulatory Framework

In their submission, dated August 8, industry associations emphasized the necessity for a regulatory framework that supports the unique needs of medical devices. They stress that medical devices should be governed through risk-based assessments and quality management systems rather than the drug-centric approach outlined in the bill.

The letter to the health minister highlights the potential setback to India’s ambitions of becoming a global hub for medical device manufacturing if the draft bill is enacted without revisions. The associations urge the government to reconsider the bill's provisions to foster a conducive environment for growth and innovation in the sector.

Global Standards and Best Practices

Globally, medical devices are regulated through standards that focus on risk management, post-market surveillance, and recalls, rather than criminal penalties. The draft bill's approach contrasts sharply with these international practices, raising concerns about India's competitiveness in the global market.

The medical device industry is advocating for alignment with international best practices to ensure that India remains attractive to investors and innovators. The stakeholders are calling for a more nuanced regulatory framework that recognizes the distinct nature of medical devices, fostering an environment that encourages technological advancement and market growth.