Industry Pushback: Medical Devices Not Pharmaceuticals, Say Companies

India's medical device industry and healthcare organizations are raising concerns over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which they argue improperly categorizes medical devices as pharmaceuticals. The draft legislation, currently under inter-ministerial review, has prompted industry leaders to caution that such a framework could hamper manufacturing growth, deter investment, and stifle innovation.

Industry's Unified Opposition

Several associations, including those representing manufacturers, traders, and patient safety groups, have collectively voiced their opposition through a letter to the Union Health Minister. They argue that the draft bill fails to acknowledge the distinct nature of medical devices, which are fundamentally engineering products, not pharmaceutical drugs. This distinction is crucial as it influences how these products should be regulated.

The letter emphasizes that the draft continues to employ drug-centric language and penalties, using terms such as "adulterated," "spurious," and "misbranded," which are inappropriate for medical devices. Such language could lead to severe consequences, including criminal penalties for regulatory lapses that are more administrative in nature, such as labeling errors or documentation issues.

Global Regulatory Practices

Industry representatives highlight that globally, medical devices are subject to risk-based conformity assessments, quality management systems, and post-market surveillance instead of the criminal penalties suggested in the draft bill. They point out that major regulatory bodies such as the European Union Medical Device Regulation (EU MDR), the United States Food and Drug Administration (US FDA), Japan's Pharmaceuticals and Medical Devices Agency (PMDA), the UK's Medicines and Healthcare products Regulatory Agency (MHRA), and Australia's Therapeutic Goods Administration (TGA) focus on administrative enforcement rather than imprisonment for non-compliance.

The draft legislation proposes imprisonment ranging from one to seven years for various infractions, including labeling errors and minor documentation lapses, even in cases where no harm has occurred. Industry leaders argue that such measures are not in line with international practices and could significantly hinder India's efforts to become a global hub for medical device manufacturing and innovation.

Call for Revisions

The medical device sector is urging the government to reconsider the draft bill, advocating for a regulatory framework that recognizes the unique nature of medical devices and aligns with global standards. The associations have stressed that a supportive regulatory environment is essential for fostering innovation and attracting investment, which are critical for the sector's growth and competitiveness on the international stage.

As the draft bill undergoes further consultation, stakeholders within the industry remain hopeful that their concerns will be addressed, leading to amendments that better reflect the needs and realities of the medical device sector.