Medical Device Industry Challenges India's Draft Bill on Regulation

India's medical device industry and healthcare groups are voicing strong opposition to the Draft Drugs, Medical Devices and Cosmetics Bill, 2026. The industry argues that the proposed legislation, which treats medical devices similarly to pharmaceutical products, could significantly impact manufacturing, innovation, and foreign investment. This reaction follows the bill's current phase of inter-ministerial consultation.

Industry Concerns Over Regulatory Approach

Associations representing manufacturers, traders, healthcare providers, and patient safety groups have expressed their concerns in a letter to the Union Health Minister. They argue that the draft bill lacks the necessary regulatory framework to support the growth and global competitiveness of India's medical device sector. The letter emphasizes that medical devices, which are engineering products, require a distinct regulatory approach compared to pharmaceuticals.

The draft bill's usage of pharmaceutical-centric terms such as "adulterated," "spurious," and "misbranded" has raised alarms. Industry stakeholders warn that applying pharma-style criminal penalties for regulatory lapses, including labelling errors and documentation issues, could deter innovation and investment.

Global Regulatory Practices Highlighted

The draft bill proposes imprisonment of 1-7 years for various non-compliance issues, even when no harm is caused. This punitive approach is in stark contrast to international norms, where administrative enforcement is preferred. Industry representatives point out that global regulators like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA focus on risk-based conformity assessments and post-market surveillance rather than criminalization.

The letter submitted on August 8 by industry associations underlines the need for a regulatory framework that acknowledges the scientific and engineering differences between medical devices and pharmaceuticals. The current draft, they argue, could hinder India's ambition to become a leading global hub for medical devices.

Call for Rethinking the Draft Bill

The medical device sector is urging a rethink of the draft bill to align with international best practices and foster an environment conducive to innovation and investment. Industry leaders emphasize the importance of establishing regulations that reflect the unique nature of medical devices, promoting growth and competitiveness in the global market.

This opposition comes as the Indian government seeks to update its 86-year-old pharmaceuticals regulation law. The ongoing debate highlights the critical need for a balanced approach that safeguards public health while encouraging technological advancement and economic growth.