Medical Device Industry Pushes Back Against New Draft Bill

India's medical device industry is rallying against the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the draft legislation could stifle innovation and investment by subjecting devices to pharmaceutical-style regulations. Industry leaders contend that the bill's approach fails to recognize the distinct nature of medical devices compared to pharmaceuticals.

Industry Concerns Over Regulatory Approach

Prominent associations representing manufacturers, healthcare providers, and patient safety groups have voiced their concerns in a letter to the Union Health Minister. They argue that the draft bill's language and provisions, which include criminal penalties for regulatory infractions, could deter manufacturing and hinder India's efforts to establish itself as a global hub for medical device production. The letter emphasizes that medical devices, being engineering products, should not be regulated in the same manner as drugs.

The draft bill proposes criminal penalties ranging from one to seven years of imprisonment for issues such as labeling errors and documentation lapses, even when no harm is caused. The industry argues that such measures are inconsistent with international norms, where administrative actions are preferred over criminalization.

Call for Risk-Based Regulation

Industry advocates underscore the need for a regulatory framework that aligns with global standards. They point out that in regions like the EU, the US, Japan, the UK, and Australia, medical devices are governed through risk-based conformity assessments, quality management systems, and post-market surveillance rather than punitive measures.

The draft bill's use of terms commonly associated with pharmaceuticals, such as "adulterated" and "misbranded," further exacerbates industry concerns. Stakeholders argue that these terms are inappropriate for the medical device sector and could lead to regulatory confusion and increased compliance costs.

Ongoing Consultations and Future Prospects

The draft bill is currently under inter-ministerial review. As discussions continue, industry groups are calling for a reevaluation of the bill's provisions to better reflect the unique characteristics and needs of the medical device sector. They advocate for a regulatory environment that encourages innovation and investment while ensuring patient safety.

With the draft bill set to replace India's 86-year-old pharmaceutical regulation framework, the outcome of these consultations will significantly impact the future trajectory of the country's medical device industry. Stakeholders remain hopeful that a balanced approach will be adopted, fostering growth and competitiveness in the global market.