Industry Pushback: Medical Devices Not Pharmaceuticals, Say Companies

India's medical device industry is voicing strong opposition to the proposed Drugs, Medical Devices and Cosmetics Bill, 2026, which aims to regulate medical devices in the same manner as pharmaceuticals. Industry associations and healthcare groups argue that this approach could stifle innovation, deter investment, and damage manufacturing prospects in India.

Industry Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, has drawn criticism from various stakeholders within the medical device sector. In a letter dated August 8 to the Union Health Minister, associations representing manufacturers, traders, and healthcare providers emphasized that medical devices differ fundamentally from pharmaceutical products. Unlike drugs, medical devices are engineering products, and the draft's pharmaceutical-centric language fails to recognize these differences, they argue.

The letter highlights concerns over the use of terms such as "adulterated," "spurious," and "misbranded," which are traditionally associated with pharmaceuticals. Furthermore, the draft proposes criminal penalties for regulatory lapses, including labelling errors and documentation issues, which the industry deems excessive and counterproductive. The associations contend that such measures could lead to imprisonment for non-compliance, a practice not seen in other major markets like the EU, US, Japan, UK, or Australia, where administrative enforcement is preferred.

Impact on India's Global Aspirations

The opposition to the draft bill is rooted in concerns that it could hinder India's ambition to become a global hub for medical devices. The industry argues that the current regulatory framework does not provide the necessary foundation for growth and global competition. Instead of fostering innovation and investment, the bill could create an environment of uncertainty and risk.

Globally, medical devices are managed through risk-based conformity assessments, quality management systems, and post-market surveillance, rather than punitive measures. The industry's stance is that aligning India's regulations with international standards would better support the sector's development and integration into the global market.

Call for Rethinking the Draft Bill

The associations' letter urges a reevaluation of the draft bill, advocating for a regulatory framework that reflects the scientific and engineering nature of medical devices. They call for policies that support innovation and investment, rather than imposing restrictive and punitive measures.

This pushback from the medical device industry underscores the need for a nuanced approach to regulation, one that distinguishes between pharmaceuticals and medical devices. As the draft bill undergoes further consultation, the industry's feedback will be crucial in shaping policies that align with global standards and support the sector's growth.