Medical Device Industry Challenges India's Draft Regulatory Bill
Medical device firms argue against India's draft bill aligning devices with pharma, citing potential harm to innovation.
India's medical device industry is raising concerns over the draft Drugs, Medical Devices and Cosmetics Bill, 2026, arguing that the proposed legislation could hinder innovation and investment by treating medical devices as pharmaceuticals. Industry groups, including manufacturers and healthcare providers, have appealed to the Union Health Ministry to reconsider the draft bill's approach.
Industry Pushback Against Regulatory Changes
The draft bill, currently under inter-ministerial review, aims to overhaul the country's 86-year-old pharmaceutical regulatory framework. However, stakeholders in the medical device sector argue that the bill's provisions are unsuitable for their industry. They contend that unlike pharmaceuticals, medical devices are engineering products and should not be subjected to drug-like regulations.
In a letter dated August 8, various associations expressed their concerns, highlighting that the bill continues to categorize medical devices alongside pharmaceuticals, ignoring the distinct scientific and regulatory differences. This, they argue, could stifle India's goal of becoming a global leader in medical device manufacturing.
Concerns Over Criminal Penalties
The draft legislation includes stringent measures such as imprisonment for labeling errors and documentation lapses, with penalties ranging from one to seven years. This approach, industry leaders say, contrasts with international standards where administrative enforcement is preferred over criminalization. They point out that major regulatory bodies like the EU MDR, US FDA, Japan PMDA, UK MHRA, and Australia TGA follow a risk-based approach, focusing on quality management and post-market surveillance rather than punitive measures.
Call for a Separate Regulatory Framework
Industry representatives are advocating for a regulatory framework tailored specifically to medical devices, emphasizing the need for policies that foster innovation and competitiveness. They stress that current drug-centric language in the draft, using terms like "adulterated" and "misbranded," is inappropriate for engineering products and could deter international investment.
As discussions continue, the medical device sector remains hopeful that the government will consider their feedback and develop a regulatory environment that supports growth without compromising safety and quality.