Medical Device Industry Pushes Back Against India's Draft Bill
Medical device firms criticize India's 2026 draft bill for equating devices with drugs, fearing stifled innovation and investment.
India's medical device industry is voicing strong opposition to the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the proposed legislation inappropriately classifies medical devices alongside pharmaceuticals. Industry leaders and healthcare groups warn that this approach could undermine manufacturing, investment, and innovation within the sector.
Concerns Over Regulatory Approach
In a letter addressed to the Union health minister, several associations representing manufacturers, traders, healthcare providers, and patient groups expressed their concerns. They argue that the draft bill threatens India's ambition to become a global hub for medical devices by imposing pharmaceutical-style regulations on devices that are fundamentally different in nature.
The medical device industry highlights that these products are primarily engineering-based, unlike pharmaceuticals, which are chemically derived. The draft's use of terms like "adulterated," "spurious," and "misbranded," alongside the application of criminal penalties for regulatory infractions, has been particularly contentious. Industry representatives emphasize that globally, medical devices are governed by risk-based assessments, quality management systems, and post-market surveillance, rather than criminalization.
International Regulatory Standards
The opposition to the draft bill points to international regulatory practices as a model for India to consider. In regions such as the European Union, the United States, Japan, the United Kingdom, and Australia, administrative enforcement prevails over criminal penalties. The draft bill's provision for imprisonment of 1-7 years for administrative errors like labeling mistakes and documentation lapses starkly contrasts with these international norms.
Industry stakeholders argue that the proposed penalties could deter investment and stifle innovation, potentially leading to negative consequences for the sector's growth. They assert that the draft bill fails to establish a conducive regulatory environment that fosters innovation and competitiveness.
Call for Rethink and Revisions
The draft bill is currently undergoing inter-ministerial consultation, and the industry has called for a thorough revision of its provisions to align with the unique characteristics of medical devices. Stakeholders urge the government to recognize the distinct nature of these products and tailor regulations that support rather than hinder the sector's development.
As the consultation process continues, the medical device industry remains hopeful that its concerns will be addressed. The outcome of these deliberations could significantly impact India's position in the global medical device market and its ability to attract international investments.