Medical Device Industry Opposes Draft Bill, Cites Regulatory Concerns

The Indian medical device industry is raising alarms over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the proposal erroneously equates medical devices with pharmaceuticals. Industry representatives warn that such an approach could stifle innovation, deter investment, and hinder India's growth as a global hub for medical devices.

Industry Concerns Over Regulatory Approach

Leading associations representing manufacturers, healthcare providers, and patient safety groups have voiced their opposition, highlighting the fundamental differences between medical devices and pharmaceutical products. They argue that medical devices, which are engineering products, should not be subjected to regulatory frameworks designed for drugs. The industry has conveyed their apprehensions to the Union Health Minister, urging a reevaluation of the draft bill.

The draft bill, currently under inter-ministerial consultation, has been criticized for retaining drug-centric language and imposing pharma-style criminal penalties. Terms such as "adulterated", "spurious", and "misbranded" are used, with penalties including imprisonment for up to seven years for issues like labelling errors and documentation lapses, even when no harm has occurred.

Global Standards and Industry Pushback

The industry points out that globally, medical devices are regulated through risk-based conformity assessments and quality management systems, rather than criminal penalties. Countries like the United States, European Union, Japan, and Australia focus on administrative enforcement and post-market surveillance, rather than punitive measures. The draft bill's approach, they argue, is inconsistent with international best practices.

In their letter dated August 8, industry associations stressed the need for a regulatory foundation that supports growth and innovation. They warned that the current draft could discourage manufacturing and investment, setting back India's ambitions of becoming a global leader in the medical device sector.

The draft bill aims to replace the existing 86-year-old law governing India's pharmaceutical regulations. However, industry stakeholders emphasize that a distinct regulatory framework is necessary for medical devices, recognizing their unique scientific and engineering characteristics.

Call for a Revised Regulatory Framework

The opposition from the medical device sector underscores the need for a nuanced regulatory approach that differentiates between pharmaceuticals and medical devices. Industry experts insist that a tailored framework is essential to foster innovation and competitiveness in the global market.

The ongoing consultations present an opportunity for stakeholders to influence the final version of the bill, ensuring that it aligns with international standards and supports the sector's growth. The medical device industry remains hopeful that their concerns will be addressed, paving the way for a regulatory environment that encourages innovation and investment.