Government plans to replace the Drugs & Cosmetics Act, 1940. This highlights a major regulatory shift. The Draft Drugs, Medical Devices & Cosmetics Bill, 2026 aims to replace the 1940 Act. It will consolidate drug, device, and cosmetic regulation under one law. It introduces a dedicated medical devices framework with risk-based classification. This will empower the DCGI with binding authority over state regulators. Additionally, it enforces stricter bail provisions for spurious or adulterated drugs. Thus, the government positions the proposed bill as a modernization move to streamline approvals and recalls. However, medical device associations are opposing it, arguing that the Bill remains pharma-centric. Moreover, it imposes disproportionate criminal penalties for technical lapses and could discourage innovation and investment. This sets the stage for intense debate between regulators and industry stakeholders over the future of India’s compliance landscape.
Draft Drugs, Medical Devices & Cosmetics Bill, 2026: A major regulatory shift
The Draft Drugs, Medical Devices & Cosmetics Bill, 2026 is India’s most ambitious regulatory overhaul in decades. It is set to repeal the 1940 Act. It will introduce a dedicated medical devices framework, empower the DCGI (renamed as Drugs & Medical Devices Controller General), tighten bail provisions for spurious/adulterated drugs, and streamline approvals and recalls. However, it faces strong opposition from medical device associations who argue it remains pharma‑centric and risks stifling innovation.
Key features of the Draft Drugs, Medical Devices & Cosmetics Bill, 2026
1. Repeal and consolidation
The Draft Drugs, Medical Devices & Cosmetics Bill, 2026 repeals the Drugs & Cosmetics Act, 1940, which has governed India’s pharma sector for over 80 years. It consolidates regulation of drugs, medical devices, and cosmetics into one unified law, thereby making compliance more streamlined. This consolidation is designed to remove overlaps between CDSCO and state regulators. By creating a single statute with 190 sections across 8 chapters, it provides a modern legal framework. Thus, the intent is to align India’s regulatory system with global standards while addressing gaps in the old Act.
2. Dedicated medical devices chapter
For the first time, medical devices are given a standalone regulatory framework. Devices will be classified into risk-based categories (Class A–D), similar to EU MDR. Licensing, conformity assessment, and clinical investigation requirements are clearly defined. A Medical Devices Technical Advisory Board will be established, which will be separate from the Drugs Advisory Board. This chapter also proposes a central medical devices testing laboratory, thereby ensuring independent evaluation and quality assurance.
3. DCGI renamed and empowered
The DCGI will be renamed as the Drugs & Medical Devices Controller General of India. This role gains binding authority over state regulators, thereby ensuring uniform enforcement across India. The DCGI can directly intervene if states fail to act, thereby reducing regulatory fragmentation. It also gains powers to fast-track approvals and recalls, thereby improving responsiveness to public health needs. This centralization strengthens India’s regulatory governance but also raises concerns about over‑centralization.
4. Stricter bail and penalties
The Draft Drugs, Medical Devices & Cosmetics Bill introduces tighter bail provisions for offences involving spurious, adulterated, or counterfeit drugs. Courts must be satisfied of innocence before bail is granted, thereby making it harder for violators to escape accountability. Penalties are graded, with severe criminal liability for major violations and administrative fines for minor lapses. This aims to deter malpractice and protect patient safety. However, medical device associations argue that applying criminal penalties to technical lapses (like labeling errors) is disproportionate.
5. Innovation and trial waivers
The Draft Drugs, Medical Devices & Cosmetics Bill allows regulators to waive trial data requirements in cases of urgent public health needs. This provision is intended to accelerate access to life‑saving drugs and devices. It encourages adoption of emerging technologies, such as AI-driven diagnostics and advanced therapies. By reducing regulatory bottlenecks, India hopes to position itself as a hub for innovation. At the same time, critics warn that trial waivers must be carefully managed to avoid compromising patient safety.
Industry concerns and opposition of the Draft Drugs, Medical Devices & Cosmetics Bill, 2026
1. Pharma-centric approach
Medical device associations argue that the Bill still treats devices as an extension of pharmaceuticals rather than as distinct engineering products. The use of drug-centric terms like “spurious” or “adulterated” is seen as inappropriate for devices, which are governed by design and performance standards. This lack of differentiation risks creating confusion and regulatory misalignment for manufacturers.
2. Disproportionate criminal liability
The Bill imposes 1–7 years of imprisonment for violations, even for technical lapses such as labeling errors or documentation mistakes. Industry stakeholders believe such penalties are excessive for non-safety related issues. They warn that this could discourage innovation and make compliance unnecessarily punitive.
3. Investment deterrent
Foreign investors and domestic startups may hesitate to enter India’s medtech market under such stringent provisions. The fear of criminal prosecution for minor infractions creates a perception of regulatory hostility. This could undermine India’s ambition to become a global hub for medical device manufacturing.
4. Demand for standalone medical devices act
Associations insist that medical devices require a separate law and not one embedded within a pharma-driven framework. They propose a National Medical Devices Regulatory Authority with risk-proportionate penalties. Such a structure would align India with global practices, such as the EU MDR, thereby ensuring clarity and investor confidence.
5. Innovation risks
By applying pharma-style compliance to devices, the Draft Drugs, Medical Devices & Cosmetics Bill, 2026, may slow down adoption of emerging technologies, such as AI-driven diagnostics and advanced imaging systems. Industry leaders fear that startups will be burdened with complex approvals and harsh penalties. This could stifle India’s competitiveness in the fast-evolving medtech sector.
Conclusions
Draft Drugs, Medical Devices & Cosmetics Bill, 2026 represents a landmark attempt to modernize India’s regulatory framework by consolidating oversight of drugs, devices, and cosmetics under one law. Its provisions, such as risk‑based device classification, expanded DCGI powers, stricter bail conditions, and trial waivers, signal a push towards stronger compliance and faster innovation pathways. However, industry stakeholders remain deeply concerned that the Bill’s pharma‑centric language and disproportionate criminal penalties could stifle medical device growth and deter investment. The debate now hinges on whether India will refine the Bill to balance enforcement with innovation or risk creating a regulatory environment that prioritizes control over competitiveness. Thus, the outcome will shape India’s ability to position itself as a global hub for pharmaceuticals and medtech in the coming decade.
