Medical Device Industry Opposes Draft Bill Over Regulatory Concerns

India's medical device industry is raising alarms over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it inappropriately equates medical devices with pharmaceuticals. Industry leaders, patient safety groups, and healthcare providers have voiced concerns that such an approach could stifle innovation and deter investment, potentially hindering India's goal of becoming a global hub for medical devices.

Concerns from Industry and Healthcare Groups

The draft bill, currently under inter-ministerial consultation, aims to update the nation's regulatory framework, replacing an 86-year-old law. However, critics argue that it fails to acknowledge the distinct nature of medical devices as engineering products, not drugs. Associations representing manufacturers, traders, and healthcare providers have submitted a letter to the Union health minister, cautioning that the bill's approach could damage the domestic industry's growth prospects.

The letter, dated August 8, criticizes the draft for using drug-centric terminology such as "adulterated," "spurious," and "misbranded," which they argue are inappropriate for regulating engineering products. The bill proposes criminal penalties for regulatory lapses, including imprisonment for labeling errors and documentation mistakes, a move the industry says is out of step with global practices.

Global Standards and Regulatory Practices

Industry representatives highlight that international regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA manage medical device regulation through risk-based assessments and quality management systems. These frameworks emphasize administrative enforcement rather than criminal penalties, focusing on post-market surveillance and recalls when necessary.

The draft bill's provisions for imprisonment ranging from one to seven years for various regulatory infractions, even when no harm occurs, stand in stark contrast to these international standards. Critics argue that such measures could dissuade potential investors and innovators from engaging with the Indian market.

Call for a Revised Regulatory Approach

Industry stakeholders are advocating for a regulatory framework that recognizes the engineering and scientific distinctions between pharmaceuticals and medical devices. They urge the government to establish regulations that foster innovation, support manufacturing, and attract investment. The current draft, they warn, lacks the necessary foundation to propel India’s medical device sector onto the global stage.

As the draft bill undergoes further review, the medical device industry remains vocal in its demand for changes that align with global best practices. The outcome of this legislative process will be crucial in determining India's future role in the global medical device market.