India's Revised Drugs, Medical Devices and Cosmetics Bill 2026 Restructures National Drug Regulatory System

India's Union health ministry has circulated a revised draft of the Drugs, Medical Devices and Cosmetics Bill, 2026, proposing to restructure the existing national drug regulatory system and extend provisions for medical devices and cosmetics, including new provisions for the Ayurveda, Unani, Siddha, Sowa-Rigpa, and Homoeopathy (AUSSH) systems. The revised draft replaces the Drugs and Cosmetics Act, 1940, with a comprehensive regulatory framework aimed at strengthening regulation, improving oversight, and ensuring greater safety, quality, efficacy, and transparency across the sector.

The Ministry stated that comments and suggestions received from various stakeholders for the draft prepared in 2022 and circulated for inter-ministerial consultation in January 2023 have been examined while preparing the revised draft. The Ministry also modified the draft to the latest version considering the Jan Vishwas Act 2026 and recent developments.

Restructured National Regulatory Authority

The draft proposes a Drugs and Medical Devices Controller General, India (搜索)搜索该词条 to serve as the National Regulatory Authority, replacing the Drugs Controller General (India) (搜索)搜索该词条 at present. It proposes two Controller Generals under the system — one for drugs and the other for medical devices. The Central government shall, by notification, appoint an officer as the Drugs and Medical Devices Controller General, India as the National Regulatory Authority, and appoint officers with appropriate qualifications and experience as Controller General (Drugs) and Controller General (Medical Devices). It shall also appoint the Central Drugs, Medical Devices and Cosmetics Regulatory Authority (AUSSH).

Dr BR Jagashetty, former National Adviser (Drugs Control) to MoHFW & CDSCO and former Karnataka state drugs controller, described the 2026 Bill as a comprehensive replacement of the 1940 Act with two key reforms: an independent regulatory framework for medical devices, and a strengthened National Regulatory Authority giving it a stature comparable to major global regulators, with greater powers over State Drugs Controllers.

Advisory Board Restructuring

The Drugs Technical Advisory Board (DTAB) and the Medical Devices Technical Advisory Board (MDTAB) will be restructured, with 15 members instead of the 21 members proposed in the previous draft. Representatives from industry, the Indian Medical Association (搜索)搜索该词条 (IMA), and the Indian Pharmaceutical Association (搜索)搜索该词条 (IPA), among others, will now sit on a newly proposed Central Advisory Committee, which will advise the DTAB and MDTAB on technical matters pertaining to drugs, cosmetics, or medical devices. Both boards shall meet at least once in six months.

The Central Advisory Committee will be chaired by the Drugs and Medical Devices Controller General, India (搜索)搜索该词条, with the Controller General (Drugs) or Controller General (Medical Devices) acting as member secretary. Members will include representatives nominated by the Central government from associations of pharma manufacturers, biopharma manufacturers, medical devices manufacturers, cosmetics manufacturers, and small scale industries, as well as representatives from recognised associations of retailers, wholesalers, distributors, and traders. The Committee will also include representatives of the central councils of IMA and IPA, civil society patient safety groups, and one person from medical or research institutions involved in clinical trials, clinical investigation, or clinical performance evaluation.

Strengthened Enforcement and Compliance

The revised draft grants the Drugs Inspector powers to arrest any person without a warrant, with prior written approval of the National Regulatory Authority or the State Regulatory Authority, if the official has reason to believe that such person has committed, is committing, or is about to commit an offence related to adulterated or spurious drugs punishable under certain sections.

The draft also mandates that no person shall sell, stock, exhibit, or offer for sale or distribution any drug except in accordance with Good Distribution Practices (GDP). Dr Jagashetty noted that the Bill codifies the power of a Drugs Inspector, with prior written approval, to arrest without a warrant any person reasonably suspected of committing serious offences involving adulterated or spurious products, and introduces a statutory requirement prohibiting the sale or distribution of drugs except in strict compliance with prescribed Good Distribution Practices.

The Bill also empowers a drug inspector, with prior written authorization, to order the immediate cessation of an entire activity or production line until compliance is demonstrated. Dr Jagashetty highlighted the Improvement Notice as a newly introduced provision requiring an opportunity for the licensee to rectify identified deficiencies through CAPA (corrective action and preventive action) before suspension or cancellation of the licence, describing it as a welcome, industry-friendly measure.

Expanded Definitions and New Regulatory Scope

The definition of spurious drugs is expanded to include products containing no active ingredient. A provision has been made to regulate online activities, and medical devices are separately defined and regulated under a dedicated chapter rather than being categorised as drugs. Homoeopathic drugs are grouped with Ayush drugs under a separate Ayush chapter, covering Ayush cosmetics and Ayush medical devices. The sale and distribution of cosmetics and Ayush drugs, previously outside the Act's regulatory framework, are now brought within its ambit, with a separate Controlling Authority for Ayush and a dedicated chapter for the manufacture and marketing of cosmetics.

The existing Act had no enabling provisions for offences and penalties relating to clinical trials and medical devices, which are now specifically addressed in the new Bill, instead of being dealt with solely under the relevant Rules.

Consultative and State-Level Coordination

The draft proposes a Drugs, Medical Devices and Cosmetics Consultative Committee, currently the Drugs Consultative Committee (DCC), with two representatives from the Central Government and the State Controller for Drugs and State Controller for Medical Devices of each State government and Union territory as members. The Committee shall supervise the functions of State Regulatory Authorities to facilitate uniform implementation of the Act across the country. Unlike the previous draft, which suggested meeting at least once in six months, the new draft suggests the committee should meet at least once in four months.

An Ayurveda, Unani, Siddha, Sowa-Rigpa and Homoeopathy Drugs, Medical Devices and Cosmetics Technical Advisory Board has been proposed, with one representative each from the AUSSH drug industry nominated by the central government. A corresponding AUSSH Consultative Committee is also proposed to advise the government, state governments, and the AUSSH board on matters for securing uniformity throughout India in the administration of the chapter's provisions.

Dr Jagashetty concluded that the Bill represents a significant step towards strengthening the regulatory framework by modernizing inspection and enforcement mechanisms, enhancing regulatory oversight, and ensuring stricter compliance with prescribed standards. By empowering inspectors with appropriate enforcement measures, strengthening action against adulterated and spurious products, and mandating compliance with Good Distribution Practices, the Bill seeks to improve accountability, deter violations, and safeguard public health.