Medical Device Industry Challenges Draft Bill Equating Devices with Pharma

India's medical device industry is voicing strong opposition against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the draft legislation, which treats medical devices akin to pharmaceuticals, poses significant threats to manufacturing, investment, and innovation within the sector.

Industry Concerns Over Draft Bill

The draft bill has stirred controversy by proposing stringent pharmaceutical-style regulations for medical devices, including criminal penalties for regulatory infractions. Industry stakeholders, including manufacturers, healthcare providers, and patient safety groups, have expressed concerns that such measures could stifle the growth of India's medical device sector.

In a letter to the Union Health Minister dated August 8, various associations highlighted that the draft fails to provide the necessary regulatory framework to support the sector's growth and global competitiveness. The letter emphasized the fundamental differences between medical devices and pharmaceuticals, which the draft bill overlooks.

Regulatory Approach Under Scrutiny

The medical device industry argues that the draft bill applies inappropriate drug-centric language and penalties to devices, using terms such as "adulterated," "spurious," and "misbranded." These terms, along with the imposition of imprisonment for documentation lapses and labeling errors, do not align with global best practices.

Industry representatives pointed out that major markets like the EU, US, Japan, UK, and Australia regulate medical devices through risk-based assessments and quality management systems, rather than criminal penalties. The draft's approach, they argue, could deter investment and discourage manufacturing efforts, undermining India's aspirations to become a global hub for medical devices.

Call for a Separate Regulatory Framework

The draft bill, currently under inter-ministerial consultation, is intended to replace the existing 86-year-old law governing pharmaceuticals in India. However, stakeholders are urging the government to consider a distinct regulatory framework that recognizes the unique nature of medical devices.

The letter to the health minister underscores the need for regulations that are tailored to the engineering and scientific nuances of medical devices. Without such differentiation, the industry warns, India's medical device sector could face setbacks in innovation and global market integration.

As the debate continues, the industry remains hopeful that their concerns will lead to a reconsideration of the draft bill, paving the way for a more supportive regulatory environment that fosters growth and innovation.