Medical Device Industry Pushes Back Against India's Draft Bill 2026

India's medical device industry is sounding alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that it wrongly categorizes medical devices alongside pharmaceuticals. Industry leaders assert that this misclassification could stifle innovation and deter investment in the sector.

Industry Concerns Over Regulatory Approach

Medical device manufacturers and healthcare groups have expressed significant concerns regarding the draft bill's regulatory framework. They argue that treating medical devices like drugs could impose stringent and inappropriate regulations on the sector. The draft proposes criminal penalties for regulatory lapses, which industry representatives claim would discourage manufacturing and innovation.

In a letter dated August 8, industry associations urged the Union Health Minister to reconsider the draft. They stressed that the bill's current form lacks the necessary regulatory foundation for the medical devices sector to flourish and compete on a global scale. The letter highlights that medical devices are fundamentally engineering products, not pharmaceuticals, and as such, should be regulated differently.

Global Regulatory Practices Highlighted

The industry points out that globally, medical devices are regulated through risk-based conformity assessments and quality management systems. Penalties typically involve administrative enforcement rather than criminal prosecution. The draft bill’s proposed penalties include imprisonment for issues such as labeling errors and documentation lapses, even when no harm occurs. This approach contrasts with practices in regions like the EU, US, Japan, UK, and Australia, where administrative measures are preferred.

The draft bill's language uses terms like "adulterated" and "spurious," which are traditionally associated with pharmaceuticals. Industry insiders argue that such language is not applicable to medical devices and could lead to unnecessary criminalization of non-compliance that does not result in harm.

Potential Impact on India's Global Ambitions

Stakeholders warn that the proposed regulations could hinder India's goal of becoming a global hub for medical devices. The stringent regulatory environment might deter foreign investment and stifle domestic innovation, ultimately impacting the sector's growth. Industry groups are advocating for a regulatory framework that recognizes the distinct nature of medical devices and supports their development and distribution.

The draft bill is currently under inter-ministerial consultation. As discussions continue, the medical device industry is hopeful that a revised approach will be adopted, one that aligns with international standards and fosters an environment conducive to growth and innovation.