India's Medical Device Industry Challenges Draft Bill Over Regulatory Concerns

India's medical device industry is raising alarms over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes regulating medical devices in a manner similar to pharmaceuticals. Industry representatives argue this approach could impede manufacturing, innovation, and investment in the sector.

Industry Pushback Against Pharmaceutical-Like Regulations

The draft bill, currently under inter-ministerial review, has drawn significant opposition from various stakeholders, including medical device manufacturers, healthcare providers, and patient safety groups. In a letter to the Union Health Minister, these groups have expressed their concerns, highlighting the fundamental differences between medical devices and pharmaceuticals.

The letter, dated August 8, 2026, criticizes the draft for failing to establish a regulatory framework conducive to the growth and global competitiveness of India's medical devices sector. It argues that medical devices are fundamentally engineering products, requiring distinct regulatory treatment from drugs.

Concerns Over Criminal Penalties and Language

The draft bill's language, which includes terms like "adulterated," "spurious," and "misbranded," is seen as inappropriate for the medical devices sector. Industry leaders argue that these terms, along with the proposed criminal penalties for regulatory lapses, mirror those used in pharmaceutical regulations and could stifle innovation.

Under the proposed bill, violations such as labelling errors or documentation issues could result in imprisonment ranging from one to seven years, even if no harm occurs. This has been criticized as overly punitive, with industry advocates pointing out that major global regulators like the EU MDR, US FDA, Japan's PMDA, UK's MHRA, and Australia's TGA typically rely on administrative enforcement rather than criminal penalties for such issues.

Call for a Distinct Regulatory Approach

Industry experts are urging the government to adopt a regulatory framework that aligns with international best practices, emphasizing risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. They argue that such an approach would better support the sector's growth and innovation goals.

The medical device industry is advocating for a clear separation between the regulatory frameworks for pharmaceuticals and medical devices, reflecting their distinct scientific and engineering characteristics. As India aims to become a global hub for medical device manufacturing, stakeholders emphasize the need for regulations that nurture rather than hinder this ambition.