Medical Device Industry Opposes India's Draft Bill Over Regulatory Concerns

India's medical device industry is raising alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it could severely impact the sector's growth and innovation. Industry leaders and healthcare groups are concerned that the bill treats medical devices as pharmaceutical products, imposing stringent penalties that could deter manufacturing and investment.

Industry Challenges the Draft Bill

Several associations representing manufacturers, healthcare providers, and patient safety groups have expressed their opposition to the draft bill. They have formally communicated their concerns to the Union Health Minister, urging a reconsideration of the proposal. The industry argues that medical devices are fundamentally different from pharmaceuticals and should not be regulated under the same framework.

In their communication dated August 8, the associations emphasized that the draft bill fails to establish a conducive regulatory environment for the growth of India's medical device sector. They point out that the bill continues to use drug-centric terminology such as 'adulterated', 'spurious', and 'misbranded', and applies criminal penalties for what they consider engineering deviations.

Potential Impact on Innovation and Investment

The draft legislation proposes imprisonment ranging from 1 to 7 years for various infractions, including labelling errors, documentation lapses, and engineering defects, even if no harm results. Industry insiders argue that such measures are not aligned with international practices. In regions like the EU, US, Japan, UK, and Australia, administrative enforcement is preferred over criminal penalties for regulatory non-compliance.

The medical device sector in India fears that these stringent regulations could discourage investment and innovation, hindering the country's ambitions to become a global hub for medical devices. The bill is currently undergoing inter-ministerial consultations, but industry leaders are hopeful that their feedback will prompt a revision.

Call for Risk-Based Regulatory Approach

Experts in the field advocate for a risk-based regulatory approach, similar to international standards, which would include conformity assessments, quality management systems, and post-market surveillance. They argue that such a framework would better support the unique characteristics and requirements of medical devices, as opposed to the drug-centric approach currently proposed.

The draft bill, intended to replace an 86-year-old law governing pharmaceuticals in India, has sparked significant debate. As stakeholders continue to voice their concerns, the future of the bill remains uncertain, with the potential for revisions that could better align with the needs of the medical device industry.