Medical Device Industry Challenges Draft Bill's Pharma-Like Regulations

India's medical device industry is raising alarms over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices in the same manner as pharmaceuticals. Industry representatives argue that such a move could stifle innovation, deter investment, and ultimately hinder India's goal of becoming a global hub for medical devices.

Concerns Over Regulatory Approach

The draft bill, currently under inter-ministerial review, has sparked opposition from a range of stakeholders, including manufacturers, traders, healthcare providers, and patient safety groups. These groups have voiced their concerns to the Union Health Minister, emphasizing that the bill's approach does not consider the fundamental differences between medical devices and pharmaceutical products.

Medical devices are characterized as engineering products rather than chemical compounds, and the industry insists that they require distinct regulatory frameworks. The draft bill's use of drug-centric language, applying terms like "adulterated" and "misbranded," alongside criminal penalties for regulatory lapses, has been particularly contentious.

Potential Impact on Innovation and Investment

The industry fears that the proposed regulations could lead to severe consequences for the medical device sector. The draft bill mandates imprisonment for offenses such as labeling errors and documentation lapses, even in cases where no harm has occurred. This type of enforcement, the industry argues, is not aligned with international practices observed in regions like the EU, US, Japan, UK, and Australia, where administrative enforcement is preferred.

By imposing stringent penalties, the bill could discourage manufacturing and investment in the sector. Industry leaders warn that these measures could undermine efforts to foster a thriving domestic market for medical devices, which is crucial for India to position itself as a competitive player globally.

Industry's Call for Revisions

In a letter dated August 8, industry associations urged the government to reconsider the draft bill's provisions. They argue that the bill fails to provide a conducive regulatory environment necessary for growth and innovation within the medical device sector. The letter highlights the need for a risk-based approach to regulation, incorporating quality management systems and post-market surveillance instead of punitive measures.

The medical device industry continues to advocate for a regulatory framework that acknowledges the unique characteristics of medical devices and supports their development and commercialization. As the draft bill undergoes further consultation, stakeholders remain hopeful that their concerns will be addressed to ensure a balanced and supportive regulatory environment.