Medical Device Industry Challenges Draft Bill's Pharmaceutical Approach

India's medical device industry and healthcare groups are raising alarms over the draft Drugs, Medical Devices, and Cosmetics Bill, 2026, which they argue inappropriately categorizes medical devices alongside pharmaceuticals. Stakeholders warn that this could stifle innovation and deter investment, threatening India's aspirations to become a global hub for medical device manufacturing.

Concerns Over Regulatory Approach

Industry representatives, including manufacturers, traders, and patient advocacy groups, have voiced their concerns through letters to the Union Health Minister. They argue that the draft bill's approach fails to recognize the fundamental differences between medical devices and pharmaceuticals. The bill's use of drug-centric language and its imposition of criminal penalties for regulatory lapses are seen as particularly problematic.

The draft bill proposes imprisonment of one to seven years for issues such as labeling errors and documentation lapses, even when no harm occurs. Industry leaders argue that such punitive measures are not aligned with international practices seen in regions like the European Union, the United States, Japan, the United Kingdom, and Australia, where administrative enforcement is typically the norm.

Industry Pushback

The draft's treatment of medical devices as an adjunct to pharmaceuticals is a significant sticking point for the industry. In an August 8 letter, associations highlighted that the bill does not lay down a suitable regulatory framework for the sector's growth and competitiveness on a global scale. They emphasized the need for regulations that reflect the engineering and scientific distinctions between devices and drugs.

Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, rather than criminalization. The industry is advocating for a regulatory framework that aligns with these international standards to foster a conducive environment for growth and innovation.

Government's Legislative Intent

The draft bill is part of a broader effort to overhaul India's pharmaceutical regulatory framework, replacing an 86-year-old law. It is currently under inter-ministerial review. While the intent is to modernize and streamline regulations, the medical device industry argues that a one-size-fits-all approach is inappropriate for its sector.

As discussions continue, industry stakeholders are urging the government to reconsider the draft bill's provisions to ensure that it supports rather than hinders the development of India's medical device industry. The outcome of these consultations will be critical in shaping the country's regulatory landscape for years to come.