Medical Device Firms Oppose Draft Bill Equating Devices with Drugs

India's medical device industry, alongside healthcare groups, has voiced strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026. The bill, which proposes treating medical devices similarly to pharmaceuticals, has sparked concerns among stakeholders who argue that such measures could stifle innovation and deter investment.

Industry Concerns Over Regulatory Approach

Industry representatives, including manufacturers and patient safety groups, have expressed dissatisfaction with the draft bill's approach. They argue that medical devices, which are engineering products, should not be regulated under the same framework as pharmaceuticals. The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," reflects a pharma-centric view that the industry finds unsuitable for medical devices.

The associations have formally communicated their concerns to the Union Health Minister, emphasizing that the bill could impede India's aspirations to become a global hub for medical device manufacturing. The letter sent on August 8 highlights the need for a distinct regulatory foundation that acknowledges the unique nature of medical devices, separate from pharmaceuticals.

Potential Impact on Innovation and Investment

The draft bill proposes criminal penalties, including imprisonment for one to seven years, for issues such as labeling errors and documentation lapses, even if no harm occurs. This approach contrasts with international practices in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement is favored over criminalization.

Industry leaders warn that these stringent measures could discourage innovation and investment in the sector. They stress that a risk-based regulatory framework, incorporating quality management systems and post-market surveillance, would better support the growth and competitiveness of India's medical device industry.

Call for Rethink and Industry-Specific Regulations

The draft bill is currently undergoing inter-ministerial consultation. Stakeholders are hopeful that their feedback will prompt a reconsideration of the proposed regulations. They advocate for a regulatory environment that fosters innovation and aligns with global best practices, ensuring that India remains competitive in the global medical device market.

The ongoing debate underscores the need for clear distinctions between pharmaceuticals and medical devices in regulatory policies, a move that industry experts believe is crucial for the sector's development.