Medical Device Industry Opposes India's Draft Bill on Regulation

The medical device industry in India has raised significant concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Industry representatives argue that the draft legislation, which treats medical devices similarly to pharmaceuticals, could potentially stifle innovation, deter investment, and undermine India's aspirations to become a global hub for medical device manufacturing.

Industry Pushback Against the Draft Bill

Prominent associations representing manufacturers, traders, healthcare providers, and patient safety groups have collectively voiced their opposition to the draft bill. They have communicated their concerns to the Union Health Minister, emphasizing that the current approach of the draft fails to acknowledge the distinct nature of medical devices compared to pharmaceuticals. These groups argue that the bill's regulatory framework lacks the necessary provisions to foster growth and innovation within the sector.

A letter dated August 8, sent by these associations, highlights the fundamental differences between medical devices and drugs, noting that devices are engineering products requiring a different regulatory approach. The letter criticizes the use of pharmaceutical-centric language in the draft, which includes terms such as "adulterated," "spurious," and "misbranded," and the application of criminal penalties reminiscent of drug regulation.

Concerns Over Regulatory Approach

The draft bill proposes imprisonment ranging from one to seven years for various infractions, such as labeling errors, documentation mistakes, licensing issues, and engineering defects, even when no harm results. Industry representatives argue that this approach is inconsistent with international standards, where administrative enforcement is the norm. They point to regulatory practices in regions such as the European Union, the United States, Japan, the United Kingdom, and Australia, where medical devices are governed through risk-based assessments, quality management systems, and post-market surveillance.

By imposing stringent penalties similar to those for pharmaceuticals, the draft bill could discourage manufacturers and investors, the industry warns. The associations contend that a more tailored regulatory framework is essential to drive innovation and support India's goal of establishing itself as a leader in the global medical device market.

Call for Revised Legislation

The medical device sector is urging the government to reconsider the draft bill and develop a regulatory framework that recognizes the unique characteristics and requirements of medical devices. Industry leaders stress the importance of aligning with international best practices to ensure the sector's sustainable growth and global competitiveness.

The draft Drugs, Medical Devices and Cosmetics Bill, 2026, is currently undergoing inter-ministerial consultation. Stakeholders hope that their feedback will lead to revisions that better accommodate the specific needs of the medical device industry, ensuring that regulatory measures do not inadvertently hinder progress.