Indian Medical Device Industry Resists Draft Bill's Pharmaceutical Approach

The Indian medical device industry is pushing back against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inappropriately categorizes medical devices alongside pharmaceuticals. Industry leaders, healthcare providers, and patient safety groups contend that such a move could stifle innovation, deter investment, and hinder India's goal of becoming a global hub for medical devices.

Concerns Over Regulatory Approach

Representatives from various associations have formally expressed their concerns through a letter to the Union Health Minister. They argue that the draft bill fails to establish a suitable regulatory framework for medical devices, which differ significantly from pharmaceuticals in terms of engineering and regulatory requirements. The industry highlights that medical devices require distinct regulatory measures, such as risk-based conformity assessments and quality management systems, rather than the drug-centric language and penalties currently proposed.

The draft bill includes provisions for criminal penalties, with imprisonment ranging from one to seven years for issues like labeling errors and documentation lapses. Industry advocates argue that such stringent measures are not aligned with international standards, referencing regulatory practices in regions such as the European Union, the United States, Japan, the United Kingdom, and Australia, where administrative enforcement is more common.

Potential Impact on Innovation and Investment

Critics of the draft legislation warn that equating medical devices with pharmaceuticals could harm India's burgeoning medical device sector. The imposition of severe penalties for regulatory deviations, even when no harm occurs, is seen as a deterrent to investment and innovation. The industry stresses the need for a regulatory environment that supports growth and competitiveness on a global scale.

The draft bill is currently under inter-ministerial review, as reported by the Economic Times. The proposed legislation aims to replace the existing 86-year-old framework governing pharmaceutical regulations in India. However, stakeholders argue that the current draft lacks the necessary provisions to adequately support the unique needs of the medical device industry.

Advocacy for Distinct Regulation

Industry leaders are advocating for a regulatory system that recognizes the distinct nature of medical devices, emphasizing that these products are engineering-based rather than pharmaceutical. They call for a shift from punitive measures to a focus on quality management and post-market surveillance. The associations are urging the government to reconsider the draft bill's approach to avoid potential setbacks in the sector's development.

The outcome of this regulatory debate will be closely watched by industry professionals and investors, as it will significantly impact the future trajectory of India's medical device sector.