Draft Bill Sparks Backlash from India's Medical Device Industry
India's medical device sector opposes a draft bill equating devices to drugs, citing regulatory concerns.
The draft Drugs, Medical Devices and Cosmetics Bill, 2026, has ignited significant opposition from India's medical device industry and healthcare groups. These stakeholders argue that the proposed legislation, which treats medical devices as pharmaceuticals, could stifle innovation and deter investment.
Industry Concerns Over Regulatory Approach
Key industry players have expressed alarm over the draft bill's approach of imposing pharmaceutical-style regulations on medical devices. They argue that such regulations fail to recognize the fundamental differences between medical devices and drugs. According to the industry, medical devices are engineering products requiring distinct regulatory frameworks. The draft bill, however, applies terms like "adulterated" and "misbranded," and introduces criminal penalties for regulatory lapses, which the industry deems inappropriate.
Associations representing manufacturers and healthcare providers have formally communicated their concerns to the Union health minister. They caution that the bill, as it stands, could undermine India's ambition to become a global hub for medical device manufacturing by discouraging investment and innovation.
Comparisons with Global Practices
Critics of the draft bill highlight that the proposed punitive measures, such as imprisonment for labelling errors or documentation mistakes, are not aligned with international practices. In regions like the European Union, United States, Japan, United Kingdom, and Australia, administrative enforcement rather than criminalization is the norm. These countries regulate medical devices through risk-based assessments, quality management systems, and post-market surveillance, focusing on administrative solutions rather than criminal penalties.
"Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls, not imprisonment," the industry letter emphasized. The draft bill's language and punitive approach are seen as a potential hindrance to the sector's growth and ability to compete on a global scale.
A Call for Rethinking the Draft Bill
The draft bill is currently under inter-ministerial consultation, and industry stakeholders are hopeful for revisions that would better support the medical device sector. They suggest the need for a separate regulatory framework that acknowledges the unique characteristics of medical devices, distinct from pharmaceuticals.
The medical device industry underscores the importance of fostering a regulatory environment that encourages innovation and growth, without resorting to punitive measures that could stifle these objectives. As the consultation process continues, stakeholders remain vigilant, advocating for a balanced approach that protects patient safety while promoting industry advancement.