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Centre releases revised draft Drugs, Medical Devices and Cosmetics Bill, 2026
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Gireesh Babu, New Delhi
August 17 , 2026
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The revised draft Drugs, Medical Devices and Cosmetics Bill, 2026, circulated by the Union health ministry recently, proposes to restructure the existing national drug regulatory system and extended provisions for medical devices and cosmetics, including addition of new provisions for these segments in the Ayurveda, Unani, Siddha, Sowa-Rigpa, and Homoeopathy (AUSSH) systems.
The Ministry has said that the comments and suggestions received from various stakeholders for the draft it has prepared in 2022 and circulated for inter-ministerial consultation in January, 2023, have been examined while preparing the revised draft. The Ministry has also modified the draft to the latest version considering the Jan Vishwas Act 2026 and recent developments, it added.
The draft proposes a Drugs and Medical Devices Controller General, India to be the National Regulatory Authority, instead of the Drugs Controller General (India) at present. It proposes two Controller Generals, one for drugs and the other for medical devices, under the system.
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 an officer with appropriate qualifications and experience as Controller General (Drugs), and Controller General (Medical Devices), says the draft. It shall also appoint the Central Drugs, Medical Devices and Cosmetics Regulatory Authority (AUSSH).
The Drugs Technical Advisory Board (DTAB) and the Medical Devices Technical Advisory Board (MDTAB) will also be restructured, with 15 members instead of 21 members proposed in the previous draft.
The representatives from the industry, Indian Medical Association (IMA), Indian Pharmaceutical Association (IPA), among others will now be in a newly proposed Central Advisory Committee - which is to advise the DTAB and MDTAB on technical matters pertaining to drugs, cosmetics or medical devices - instead of their proposed presence in the DTAB. Both the boards shall meet at least once in six months.
For the proposed Central Advisory Committee, the Drugs and Medical Devices Controller General, India will be the chairperson, while the controller general (Drugs) or (Medical Devices), as the case may be, would act as the member secretary. In this Committee, the representatives nominated by the Central government from amongst the associations of pharma manufacturers, biopharma manufacturers, medical devices manufacturers, cosmetics manufacturers, and associations of small scale industries, would be members. Representatives nominated by the Central government from the recognised associations of retailers, wholesalers and distributors and traders will also be present in the Committee.
Representatives of the central councils of IMA, IPA, civil society patient safety groups, and one person from medical or research institutions in clinical trials or clinical investigation or clinical performance evaluation would also be members of the Committee. The ministry of consumer affairs, ministry of commerce, ministry of MSME, and Department of Pharmaceuticals will also have one member each. One expert from the biomedical technology, biomaterial or polymer technology from recognised technical educational institutions nominated will be a member.
It will also have two experts from the medical device industry, including in vitro diagnostics, and three experts from medical, surgical or dentistry practices nominated by the Centre from the central or state government institutions as members. The State governments are also required to constitute similar committees and appoint Controllers for drugs and medical devices.
The draft also proposes a Drugs, Medical Devices and Cosmetics Consultative Committee, which is 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 or their representatives as members. The Committee shall supervise the functions of State Regulatory Authorities to facilitate uniform implementation of the Act across the country in such manner may be prescribed. Unlike the previous draft which suggested meeting of this committee at least once in six months, the new draft suggests that the committee should meet at least once in four months.
The revised draft also dedicates separate chapters of the Bill to drugs, medical devices and cosmetics, with detailed provisions to deal with these different categories.
It proposes powers to the Drugs Inspector to arrest any person, 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 and punishable under certain sections. The Drugs Inspector can "...with the prior written approval of the National Regulatory Authority or the State Regulatory Authority, as the case may be, may arrest such person without a warrant, and shall, as soon as may be, inform him of the grounds for such arrest..." it says.
The draft also mandates that no person shall sell, stock, exhibit or offer for sale or distribution, any drug, except in accordance with the good distribution practices (GDP). The Chapter VII of the revised draft proposes provisions relating not only to drugs under the AUSSH systems, but also medical devices and cosmetics under these systems, expanding the regulatory purview.
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 to be nominated by the central government.
It also proposes setting up of an Ayurveda, Unani, Siddha, Sowa-Rigpa and Homoeopathy Drugs, Medical Devices and Cosmetics Consultative Committee to advise that government, the state governments and the board (AUSSH) on any matter for the purpose of securing uniformity throughout India in the administration of the provisions of this Chapter. State regulatory authority notified by the States and Union Territories to be part of this committee.
"The Committee will supervise the functions of the respective State Regulatory Authorities to facilitate uniform implementation of the provisions of this Chapter across the country in such manner as may be prescribed," it said.
The revised bill has been proposed to repeal and consolidate the law relating to the import, manufacture, distribution and sale of drugs, medical devices and cosmetics to ensure their quality, safety, efficacy, performance and clinical trial of new drugs, clinical investigation of investigational medical devices and clinical performance evaluation of new in vitro diagnostic medical devices, for encouraging innovation and emerging technologies in development, protection and promotion of health, and for matters connected, it says.
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