Medical Device Industry Opposes Draft Bill Over Pharma Regulations

India's medical device industry and healthcare groups have expressed strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices under the same framework as pharmaceuticals. Industry representatives argue this approach could stifle innovation, deter investment, and undermine India's potential as a global medical device hub.

Concerns Raised Over Regulatory Framework

Organizations representing manufacturers, healthcare providers, and patient safety groups have reached out to the Union Health Ministry, urging a reconsideration of the bill. They argue that medical devices, which are fundamentally engineering products, should not be treated as pharmaceuticals. The draft bill, they claim, fails to establish a regulatory foundation that supports the growth and innovation of the medical device sector.

A letter dated August 8, submitted by multiple associations, highlights the industry's concern that the draft continues to treat medical devices as an adjunct to pharmaceuticals. This perspective ignores the distinct scientific, engineering, and regulatory differences between the two categories. The letter emphasizes that the language of the draft, with terms such as "adulterated," "spurious," and "misbranded," is drug-centric and inappropriate for the medical devices sector.

Potential Impact on Manufacturing and Innovation

The proposed bill includes stringent penalties, including imprisonment for one to seven years for issues such as labeling errors, documentation lapses, and licensing issues, even in cases where no harm has occurred. Industry experts argue that such criminalization of engineering deviations is not in line with global practices. In regions like the EU, US, Japan, UK, and Australia, regulatory frameworks focus on risk-based conformity assessments, quality management systems, and administrative enforcement rather than criminal penalties.

Medical device stakeholders fear that these proposed regulations could discourage domestic manufacturing and innovation at a time when India is striving to establish itself as a global leader in the medical device industry. The draft bill's approach might lead to increased compliance costs and create a challenging environment for local manufacturers, impacting their competitiveness on the international stage.

Industry's Call for a Nuanced Approach

The medical device industry is advocating for a regulatory framework that recognizes the unique characteristics of medical devices. They are calling for regulations that are aligned with international standards and practices, which focus on risk management and quality assurance rather than punitive measures.

The draft bill is currently undergoing inter-ministerial consultations, and stakeholders are hopeful that their concerns will be addressed to foster a more conducive environment for growth and innovation in India's medical device sector.