Medical Device Industry Challenges India's New Regulatory Draft
The draft Drugs, Medical Devices, and Cosmetics Bill, 2026 faces opposition for equating medical devices with pharmaceuticals.
India's medical device sector is voicing strong opposition to the proposed Drugs, Medical Devices, and Cosmetics Bill, 2026, which they argue inappropriately regulates medical devices under pharmaceutical guidelines. Industry leaders claim this approach could stifle innovation and investment, undermining India's aspirations to become a global leader in medical device manufacturing.
Industry Pushback Against Draft Bill
Several key industry associations, representing manufacturers, healthcare providers, and patient safety groups, have expressed concerns in a letter addressed to the Union Health Minister. They argue that the draft bill lacks the necessary framework to support the growth and competitiveness of India's medical device sector. The letter highlights that medical devices are fundamentally different from pharmaceuticals, being engineering products that should not be subjected to drug-like regulations.
The draft bill currently under inter-ministerial review proposes criminal penalties for regulatory violations, which the industry believes could deter investment and innovation. The bill suggests imprisonment for infractions such as labeling errors and documentation lapses, a move criticized for being excessively stringent compared to international norms.
Concerns Over Regulatory Language
Industry representatives have pointed out that the draft bill continues to use pharmaceutical-centric terms such as "adulterated" and "spurious," which they argue are inappropriate for medical devices. They emphasize that globally, medical devices are regulated through risk-based assessments and quality management systems rather than punitive measures.
According to the industry, the draft bill's approach contrasts with regulatory practices in regions like the European Union, United States, Japan, United Kingdom, and Australia, where administrative enforcement is preferred over criminal penalties. The associations argue that adopting a similar framework could better support the sector's growth and innovation.
Call for Revisions
The opposition to the draft bill is part of a broader call for revisions that would more accurately reflect the distinct nature of medical devices. The industry is advocating for a regulatory model that encourages innovation while ensuring safety and effectiveness through appropriate oversight mechanisms.
The draft bill represents a significant change from the current regulations, which have been in place for 86 years. As India aims to strengthen its position in the global medical device market, stakeholders are urging the government to consider a more tailored regulatory approach that aligns with international best practices.