Medical Device Sector Challenges India's Draft Bill on Regulatory Grounds

The Indian medical device industry has raised substantial concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026. Industry leaders argue that the proposed legislation erroneously categorizes medical devices under the same regulatory framework as pharmaceuticals, potentially stifling innovation and deterring investment in the sector.

Industry Pushback on Regulatory Approach

Various associations representing manufacturers, healthcare providers, and patient safety groups have formally addressed their concerns to the Union Health Minister. They argue that medical devices, fundamentally engineering products, require distinct regulatory measures compared to pharmaceuticals. The draft bill's approach, which includes criminal penalties for regulatory lapses, could be detrimental to India's ambitions of becoming a global hub for medical device manufacturing.

The draft bill is part of an effort to replace the current 86-year-old pharmaceutical regulation law. However, critics have pointed out that the draft uses drug-centric language, applying terms such as "adulterated," "spurious," and "misbranded" to medical devices, which they argue are inappropriate for engineering products. The bill also proposes severe penalties, including imprisonment for up to seven years for minor infractions such as labelling errors or documentation lapses, even when no harm is caused.

Global Standards vs. Proposed Indian Regulations

Industry representatives emphasize that globally, medical devices are regulated through frameworks that focus on risk-based conformity assessments, quality management systems, and post-market surveillance. Notable international regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA adopt administrative enforcement rather than criminal penalties for regulatory deviations.

The draft bill, currently under inter-ministerial consultation, is seen as lacking the necessary regulatory foundation to support the growth and global competitiveness of India's medical device sector. By treating devices as an adjunct to pharmaceuticals, the bill overlooks the scientific and engineering distinctions that necessitate a tailored regulatory approach.

Calls for a Rethink

On August 8, several industry associations submitted a letter to the Union Health Minister urging a reconsideration of the draft bill. They highlighted the risk of discouraging manufacturing and innovation if the current provisions are enacted. The associations argue that the bill's punitive measures, which are not aligned with international standards, could deter investments and hinder India's progress in the medical device industry.

The opposition to the draft bill underscores the need for a regulatory framework that acknowledges the unique characteristics of medical devices. As the government continues consultations, stakeholders hope for a revised approach that fosters innovation while ensuring patient safety and compliance.