Medical Device Industry Opposes Draft Bill Treating Devices as Drugs

India's medical device industry and healthcare groups are pushing back against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it unjustifiably treats medical devices as pharmaceutical products. Industry representatives warn that this approach could stifle manufacturing, deter investment, and hinder innovation.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, aims to replace the existing 86-year-old regulations governing pharmaceuticals. However, associations representing manufacturers, traders, healthcare providers, and patient groups have expressed their concerns in a letter to the Union health minister. They argue that the bill fails to establish a suitable regulatory framework for the growth and global competitiveness of India’s medical device sector.

In their August 8 letter, industry stakeholders stressed that medical devices are fundamentally engineering products, distinct from pharmaceuticals, and should not be regulated as drugs. They emphasized that the draft continues to use drug-centric terminology such as "adulterated," "spurious," and "misbranded," which are inappropriate for engineering products.

Potential Impact on Innovation and Investment

The industry warns that the bill's provisions, which include criminal penalties such as imprisonment for labeling errors, documentation lapses, and licensing issues, could significantly deter innovation and investment. These penalties would apply even in cases where no harm is caused, contrasting with international practices.

Globally, medical devices are regulated through risk-based conformity assessments and quality management systems rather than criminalization. The letter highlights that regions such as the European Union, the United States, Japan, the United Kingdom, and Australia employ administrative enforcement, not imprisonment, for regulatory deviations.

Calls for a Separate Regulatory Framework

Stakeholders are advocating for a distinct regulatory framework for medical devices, separate from pharmaceuticals, to foster innovation and investment in the sector. They argue that the current draft bill does not provide the necessary foundation for the sector to grow and compete on a global scale.

As the draft bill undergoes further consultation, the medical device industry continues to lobby for changes that recognize the unique nature of medical devices and ensure a conducive regulatory environment for their development.