India's Medical Device Industry Challenges Draft Bill's Pharma Parallels
Industry voices argue the Draft Bill, equating medical devices with drugs, threatens innovation and investment.
The Indian medical device industry, alongside healthcare providers and patient safety groups, is raising alarms over the proposed Drugs, Medical Devices and Cosmetics Bill, 2026. Stakeholders argue the draft legislation, which equates medical devices with pharmaceutical products, could stifle innovation and deter investment in the country's burgeoning medical device sector.
Industry Concerns Over Regulatory Approach
Several associations representing manufacturers, traders, and healthcare providers have formally expressed their opposition to the draft bill. In a letter to the Union Health Minister dated August 8, these groups emphasized that treating medical devices as pharmaceutical products fails to recognize the distinct scientific and engineering nature of these tools. The letter warned that such an approach could undermine India's aspirations to become a global leader in medical device manufacturing.
The draft bill proposes to replace the existing 86-year-old legislation governing pharmaceutical regulations in India. However, the industry argues that it does not provide a suitable regulatory framework for the medical devices sector. The proposed regulations include criminal penalties for issues such as labelling errors and documentation lapses, which the industry believes are inappropriate for engineering products.
Comparisons with Global Standards
Industry representatives have pointed out that international standards for medical device regulation differ significantly from those for pharmaceuticals. For instance, regions like the European Union, the United States, Japan, the United Kingdom, and Australia employ risk-based conformity assessments and quality management systems instead of criminal penalties for regulatory non-compliance.
The draft bill's language, which uses terms like "adulterated," "spurious," and "misbranded," is seen as drug-centric and not suitable for the medical device sector. The industry highlights that globally, administrative enforcement, rather than imprisonment, is the norm for addressing regulatory issues in medical devices.
Call for a Revised Regulatory Framework
The letter to the Health Minister strongly urges a reconsideration of the draft bill to better align with international practices and support the growth and innovation of the medical device sector in India. The industry is advocating for a regulatory framework that acknowledges the unique characteristics of medical devices and encourages rather than hinders their development.
As the draft bill undergoes inter-ministerial consultations, the medical device industry remains hopeful that their concerns will be addressed. They continue to push for regulations that enable the sector to thrive and contribute significantly to India's healthcare infrastructure.