Medical Device Firms Oppose Draft Bill, Citing Pharma Comparisons
Industry leaders argue the draft bill equates medical devices with drugs, potentially stifling innovation and investment.
The proposed Drugs, Medical Devices and Cosmetics Bill, 2026, has stirred significant opposition from India's medical device industry and healthcare groups. These stakeholders argue that the draft bill treats medical devices as pharmaceutical products, a move they believe could hinder manufacturing, innovation, and investment in the sector.
Industry's Concerns Over Regulatory Framework
In a letter addressed to the Union Health Minister, associations representing manufacturers, traders, healthcare providers, and patient groups expressed their concerns. They warned that the bill could impact India's aspirations to become a global hub for medical devices. The industry leaders emphasized that medical devices, being engineering products, should not be regulated as pharmaceuticals. They highlighted the necessity for a distinct regulatory framework that aligns with international standards.
Currently under inter-ministerial consultation, the draft bill aims to replace an 86-year-old law governing pharmaceuticals in India. However, industry representatives are concerned that the draft bill lacks the necessary provisions to support growth and innovation in the medical device sector. According to insiders, the bill continues to use language and penalties suited to pharmaceuticals, including terms like "adulterated," "spurious," and "misbranded," which are not applicable to engineering products.
Comparison with Global Practices
The industry has criticized the draft bill's inclusion of criminal penalties for regulatory lapses, which could range from 1 to 7 years of imprisonment for issues such as labeling errors or documentation lapses, even when no harm occurs. They argue that such measures are not in line with global practices. In regions like the European Union, the United States, Japan, the United Kingdom, and Australia, medical devices are regulated through risk-based assessments, quality management systems, and post-market surveillance, with administrative enforcement being the norm.
By adopting a pharmaceutical-centric approach, the draft bill may inadvertently impose stringent regulations that could discourage investment and stifle innovation. Industry voices stress the importance of aligning India's regulatory framework with international standards to ensure competitiveness and foster a conducive environment for growth.
Call for a Reevaluation
The letter from industry groups calls for a reevaluation of the draft bill to recognize the distinct nature of medical devices. They advocate for a regulatory approach that supports the sector's unique needs and facilitates its expansion on a global scale. As the consultation process continues, stakeholders hope that their concerns will be addressed to create a more favorable regulatory environment.
As the debate over the draft bill unfolds, the medical device industry remains vocal about the need for policies that acknowledge the sector's engineering focus and its potential to drive economic growth and innovation in India.