Indian Medical Device Industry Rejects Equating Devices with Pharma in New Bill
Industry leaders argue the Draft Bill's pharma-style regulations threaten innovation and investment.
The Indian medical device sector is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to regulate medical devices similarly to pharmaceuticals. Industry representatives, patient advocacy groups, and healthcare providers have collectively expressed concerns that the draft legislation could stifle innovation and discourage investment in the sector.
Draft Bill Draws Industry Ire
The contentious draft bill has prompted a coalition of associations representing manufacturers, traders, and healthcare providers to write to the Union Health Minister. The letter, dated August 8, argues that the bill's provisions do not adequately support the growth and global competitiveness of India's medical devices industry. By treating medical devices as pharmaceutical products, the bill overlooks the distinct scientific and engineering differences between the two categories.
The primary criticism revolves around the bill's use of pharmaceutical-centric language and the imposition of harsh penalties for regulatory lapses. These include terms such as "adulterated," "spurious," and "misbranded," which are more applicable to drugs than to engineering products. The bill proposes imprisonment of one to seven years for issues like labelling errors and documentation lapses, even if no harm occurs.
Global Regulatory Standards Cited
The industry argues that the proposed criminal penalties are inconsistent with international practices. Regulatory bodies in regions such as the European Union, the United States, Japan, the United Kingdom, and Australia typically employ administrative enforcement measures rather than criminal sanctions for similar infractions. These regions focus on risk-based conformity assessments, quality management systems, and post-market surveillance.
According to industry insiders, the draft bill's approach could deter potential investors and hinder the sector's ability to compete globally. The medical devices industry has been identified as a key area for development in India's economic strategy, with ambitions to become a global hub for medical device manufacturing.
Call for Legislative Revisions
The draft bill, currently under inter-ministerial consultation, aims to replace the existing 86-year-old law governing pharmaceuticals in India. However, stakeholders in the medical device industry are advocating for revisions that would create a more conducive regulatory environment. They emphasize the need for a framework that recognizes the unique characteristics of medical devices and supports innovation and growth.
As the government reviews feedback from various stakeholders, the medical device industry remains hopeful for amendments that align with international standards and foster a thriving ecosystem for innovation and manufacturing in India.