Indian Medical Device Industry Opposes Draft Bill on Regulatory Grounds

India's medical device industry has raised significant concerns over the proposed Drugs, Medical Devices, and Cosmetics Bill, 2026. Industry leaders argue that the bill erroneously classifies medical devices alongside pharmaceutical products, potentially stifling innovation and investment.

Concerns Over Classification and Penalties

Medical device manufacturers, along with healthcare groups, have expressed apprehension that the draft bill's approach could harm the sector's growth. They contend that medical devices, fundamentally engineering products, should not be regulated as pharmaceuticals. The bill includes provisions for severe penalties, including imprisonment for regulatory lapses, which the industry argues could deter investment and manufacturing efforts.

In a letter to the Union Health Minister, several associations, representing a broad spectrum of stakeholders, emphasized the need for a distinct regulatory framework that recognizes the unique nature of medical devices. The letter criticized the draft for using drug-centric terminology such as "adulterated" and "spurious," which do not align with the engineering and technical nature of medical devices.

Global Regulatory Practices

The industry has pointed out that the draft bill's punitive measures are not in line with international practices. In regions like the EU, US, Japan, UK, and Australia, regulatory frameworks focus on risk-based assessments and quality management systems rather than criminal penalties. These international standards prioritize administrative enforcement over criminalization, a practice many in the Indian industry believe should be mirrored in the new bill.

The draft proposes imprisonment ranging from one to seven years for various infractions, including labeling errors and documentation lapses. Industry representatives argue that such measures are excessive, especially when no harm has occurred, and could discourage global companies from investing in India.

Call for a Rethink

The opposition to the draft bill comes at a time when India is striving to position itself as a global hub for medical device manufacturing. Stakeholders argue that a supportive regulatory environment is crucial for fostering innovation and attracting foreign investment. They have called for a comprehensive review of the bill to ensure it provides a conducive environment for growth and aligns with global best practices.

The draft bill is currently undergoing inter-ministerial consultation, and the industry remains hopeful that their concerns will prompt revisions that better reflect the distinct nature of medical devices.