Medical Device Industry Opposes Draft Bill Equating Devices with Pharma

The Indian medical device industry has voiced strong opposition to the Draft Drugs, Medical Devices and Cosmetics Bill, 2026, which proposes to regulate medical devices in the same manner as pharmaceuticals. Industry leaders, patient safety groups, and healthcare providers argue that the bill's approach could significantly impede innovation and investment in the sector.

Industry Concerns Over Regulatory Alignment

Representatives from various associations, including manufacturers and healthcare providers, have formally communicated their concerns to the Union Health Minister. They argue that medical devices, fundamentally different from pharmaceuticals, require a distinct regulatory framework. The draft bill's current form, they say, does not support the sector's growth ambitions or its potential to position India as a global hub for medical devices.

The medical device industry points out the stark differences between engineering products like medical devices and pharmaceutical drugs. They emphasize that applying drug-centric regulations, such as those concerning adulteration and misbranding, to medical devices is inappropriate and could stifle innovation.

Implications of Criminal Penalties

One of the primary objections raised by the industry is the bill's inclusion of criminal penalties for regulatory infractions, including labelling errors and documentation lapses. These penalties range from one to seven years of imprisonment, even in cases where no harm has occurred. The industry highlights that such punitive measures are not standard practice in major regulatory jurisdictions like the European Union, the United States, or Japan, where administrative enforcement is preferred.

The draft bill's language and its potential impact on the industry have led to calls for a reconsideration of the proposed regulations. Stakeholders insist that a risk-based regulatory approach, similar to those employed internationally, would be more suitable for the medical device sector.

Seeking a Balanced Approach

In their August 8 letter, the associations urged the government to create a regulatory environment that fosters innovation and supports the medical device industry's unique needs. They argue that the bill's current form fails to provide the necessary foundation for the sector's expansion and global competitiveness.

As the draft bill undergoes inter-ministerial consultation, the medical device industry remains hopeful for amendments that acknowledge the distinct characteristics of medical devices and align regulatory practices with international standards.

The ongoing dialogue between industry stakeholders and the government underscores the critical need for regulations that balance safety and innovation, ensuring the continued growth of India's medical device sector.