Medical Device Industry Pushes Back Against Draft Bill in India
Indian medical device firms oppose a draft bill treating devices like drugs, fearing it could stifle innovation and investment.
The Indian medical device sector is raising concerns over a proposed law that could impose stringent pharmaceutical-like regulations on their products. The Draft Drugs, Medical Devices and Cosmetics Bill, 2026, currently under inter-ministerial review, has been met with opposition from industry groups who argue it could hinder manufacturing, investment, and innovation within the sector.
Industry Concerns Over Regulatory Approach
Associations representing manufacturers, healthcare providers, and patient safety groups have expressed disapproval of the draft bill's approach to regulating medical devices as pharmaceuticals. In a letter to the Union Health Minister dated August 8, these groups warned that the bill's current form could derail India's aspirations of becoming a global hub for medical device manufacturing.
The industry's main contention is that medical devices, which are engineering products, should not be regulated under the same framework as drugs. The draft bill retains drug-centric terminology such as "adulterated" and "misbranded," applying criminal penalties for regulatory lapses traditionally handled through administrative measures in other regions.
Global Standards and Industry Feedback
The draft proposes severe penalties, including imprisonment for 1-7 years for errors in labeling, documentation, licensing, and post-market surveillance, even if no harm is caused. Industry representatives argue that such measures are not aligned with global practices. In regions like the European Union, United States, Japan, the United Kingdom, and Australia, regulatory compliance is enforced through risk-based assessments and quality management systems rather than criminal sanctions.
Medical device firms fear that the draft bill's punitive measures could discourage investment and innovation, essential for the sector's growth. Industry leaders emphasize the need for a regulatory framework that supports both innovation and safety without stifling the development of new technologies.
Call for a Revised Regulatory Framework
As the draft bill undergoes further consultations, the medical device industry continues to advocate for a revised approach that distinguishes between pharmaceuticals and medical devices. Stakeholders suggest adopting a regulatory model that facilitates growth while ensuring patient safety through appropriate oversight and quality assurance mechanisms.
The draft bill aims to replace an 86-year-old legal framework governing pharmaceuticals in India. However, industry participants stress the importance of crafting a modern, nuanced regulatory environment that recognizes the unique characteristics and requirements of medical devices.