Medical Device Industry Challenges Draft Bill's Pharma-Like Regulations

India's medical device industry and healthcare organizations are raising concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices in a manner similar to pharmaceuticals. The industry's response highlights fears that this approach could stifle manufacturing, deter investment, and impede innovation.

Industry Pushback Against Draft Legislation

The draft bill has prompted a wave of objections from various stakeholders, including industry associations, healthcare providers, and patient safety groups. These entities have collectively urged the Union health minister to reconsider the draft, emphasizing the distinct nature of medical devices as engineering products rather than pharmaceuticals.

In a letter dated August 8, industry representatives argued that the bill lacks the necessary regulatory framework to foster growth and competitiveness in India's medical device sector. They pointed out that the draft continues to treat medical devices as secondary to pharmaceuticals, ignoring the clear scientific, engineering, and regulatory differences between the two categories.

Concerns Over Criminal Penalties

One of the key points of contention is the draft's inclusion of stringent penalties akin to those in the pharmaceutical sector. The bill proposes imprisonment ranging from one to seven years for issues such as labeling errors, documentation lapses, and licensing problems, even if no harm results from these deviations.

The industry's letter stresses that such punitive measures are not in line with international practices. In regions like the European Union, United States, Japan, United Kingdom, and Australia, administrative enforcement is the norm for regulating medical devices, focusing on risk-based conformity assessments, quality management systems, and post-market surveillance.

Potential Impact on India's Medical Device Ambitions

The opposition to the draft bill is rooted in concerns that it could derail India's ambitions of becoming a global hub for medical device manufacturing. Industry insiders warn that the proposed regulations may discourage both domestic and foreign investment, ultimately affecting the sector's ability to innovate and compete on a global scale.

The draft legislation is currently undergoing inter-ministerial consultation, marking a critical phase for stakeholders to influence the final outcome. As the government considers replacing the existing 86-year-old law governing pharmaceuticals, the medical device industry is keen to ensure that new regulations are tailored to the unique characteristics and needs of their products.