Medical Device Industry Rejects Draft Bill, Cites Pharma Comparison

The draft Drugs, Medical Devices and Cosmetics Bill, 2026, has drawn significant opposition from India's medical device industry and healthcare groups. They argue that equating medical devices with pharmaceuticals could impede manufacturing, deter investment, and stifle innovation.

Industry Pushback Against Regulatory Changes

Stakeholders, including industry associations and patient safety groups, have expressed their concerns in a letter to the Union health minister, urging a reevaluation of the proposed legislation. The letter highlights that the bill's approach fails to recognize the fundamental differences between medical devices and pharmaceuticals, treating the former as an adjunct to the latter. This, they argue, undermines the sector's potential for growth and global competitiveness.

Central to their argument is the distinction between medical devices, which are engineering products, and pharmaceuticals. The draft bill's language, they claim, remains drug-centric, employing terms such as "adulterated," "spurious," and "misbranded," which are more applicable to pharmaceuticals. The industry fears that this could lead to inappropriate criminal penalties for regulatory lapses in the medical device sector.

Concerns Over Criminal Penalties

The draft bill proposes imprisonment for a range of infractions, including labelling errors and documentation lapses, with penalties ranging from one to seven years. Industry representatives argue that such measures are not in line with international practices. They point out that in regions like the European Union, United States, Japan, and Australia, regulatory enforcement typically involves administrative actions rather than criminal penalties.

Globally, medical devices are regulated through risk-based conformity assessments, quality management systems, post-market surveillance, and recalls. The industry asserts that the draft bill's approach could discourage innovation and hamper India’s ambition to become a leading hub for medical devices.

Call for a Distinct Regulatory Framework

The associations have called for a regulatory framework that acknowledges the scientific and engineering nuances of medical devices. The current draft, they argue, does not provide the necessary foundation for the sector to thrive and compete on a global stage. The draft's potential impact on investment and manufacturing could hinder India's prospects in the global medical device market.

The draft bill is currently under inter-ministerial consultation, and the industry hopes that their concerns will be addressed to foster a more conducive environment for the growth of the medical device sector.