Medical Device Firms Challenge Pharmaceutical-Like Regulations

India's medical device industry is raising concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue treats medical devices as pharmaceuticals. Stakeholders fear this approach could stifle innovation and deter investment, as the bill includes stringent criminal penalties for regulatory breaches.

Industry Appeals for Regulatory Distinction

Various associations representing manufacturers, traders, and healthcare providers have appealed to the Union health minister to reconsider the draft bill. Their primary contention is that medical devices, being engineering products, should not be subjected to the same regulations as pharmaceuticals. The associations emphasized that such classification could undermine India's goal of becoming a global hub for medical devices.

The letter to the minister, dated August 8, highlights the lack of a regulatory framework that supports the growth and innovation of the medical device sector. It critiques the draft for continuing to use drug-centric terminology and approaches, such as labeling issues as "adulterated" or "misbranded," and imposing criminal penalties similar to those in the pharmaceutical industry.

Global Practices Highlighted

The industry groups argue that globally, regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA employ administrative enforcement rather than criminalization for compliance issues. They point out that the draft bill's provisions for imprisonment of one to seven years for issues like labeling errors or documentation lapses are not in line with international norms, where risk-based assessments and quality management systems are preferred.

Moreover, the associations stress that the proposed bill could discourage local manufacturing and deter foreign investment if it does not provide a conducive environment for the medical device sector. They urge the government to consider a regulatory framework that recognizes the distinct nature of medical devices, focusing on conformity assessments and post-market surveillance.

Ongoing Consultation Process

The draft bill is currently under inter-ministerial consultation, as the government seeks to replace the outdated 86-year-old law governing pharmaceutical regulations in India. While the medical device industry acknowledges the need for updated regulations, they insist that the unique engineering and scientific aspects of medical devices must be considered separately from pharmaceuticals.

This pushback from the industry underscores the broader conversation about how best to regulate medical devices while fostering an environment conducive to technological advancement and market growth. As the consultation process continues, stakeholders hope for a regulatory framework that aligns with global standards and supports India's ambition in the medical device sector.