Last Updated on August 17, 2026 by The Health Master
Highlights: Drugs, Medical Devices and Cosmetics Bill 2026
The Ministry of Health and Family Welfare of India has rolled out an updated version of the Drugs, Medical Devices and Cosmetics Bill 2026.
This bill was created to replace the outdated Drugs and Cosmetics Act of 1940.
The new Drug, Medical Devices and Cosmetics Bill 2026 also incorporates updates from the Jan Vishwas Act 2026 as well as feedback from the public consultations regarding the drug safety bill.
The bill establishes a dual-leadership model under a single regulatory entity to oversee the rapidly expanding pharmaceutical and medical device sectors:
- National Regulatory Authority: Led by the Drugs and Medical Devices Controller General, India, the new regulatory authority will replace the Drugs Controller General of India (DCGI).
- Controller General (Drugs): Dedicated to pharmaceutical oversight, manufacturing compliance, and drug safety.
- Controller General (Medical Devices): Dedicated to high-tech diagnostics, medical hardware, and emerging health technologies.
- AUSSH Integration: There will be a separate regulatory authority for ayurvedic medicines, Unani, Sidha, Sowa-rigpa, and homoeopathy medicines.
Technical Boards & The Central Advisory Committee
In an effort to streamline the functioning of the Drugs Technical Advisory Board (DTAB) and the Medical Devices Technical Advisory Board (MDTAB), they have been trimmed down from 21 members to 15 members each.
The industry representatives, patient advocates and professional bodies have been grouped into a newly established Central Advisory Committee that will serve as an advisory panel to the DTAB and the MDTAB.
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The Central Advisory Committee will bring together experts and officials from various fields to inform the policy that is to be followed within the DTAB and the MDTAB:
- Trade and Industry Representatives: Representatives from the pharmaceutical, biopharmaceutical, medical device, cosmetic and small-scale manufacturing industries.
- Supply Chain: Recognized bodies representing the supply chain of pharmaceutical and medical devices.
- Healthcare and Patient Safety Experts: Experts from the Indian Medical Association (IMA), the Indian Pharmaceutical Association (IPA) and other patient safety groups.
- Government Ministries: The Ministry of Drugs and the Ministries of MSME, Commerce and Consumer Affairs.
- Technical Specialists: Experts in the technical fields related to the industries such as polymer technology, biomaterials, biomedical engineering and clinical diagnostics.
Strengthening Enforcement & Distribution Standards
The 2026 bill includes the following enhancements to the regulatory authority of each state:
| Regulatory Feature | Old Framework | Revised 2026 Bill |
| Consultative Committee Meetings | Held every 6 months | Mandatory every 4 months to ensure uniform nationwide enforcement |
| Arrest Powers for Fake Drugs | Standard judicial procedures | Drug Inspectors can arrest without a warrant for spurious/adulterated drugs (with prior written approval) |
| Supply Chain Compliance | Basic licensing rules | Mandatory adherence to Good Distribution Practices (GDP) for storage and sales |
| AYUSH/AUSSH Purview | Primarily drug-focused | Broadened to explicitly regulate AUSSH-based devices and cosmetics |
Expanding Traditional Medicine Oversight (AUSSH)
The bill will place traditional medicines under the same regulatory authority as modern medicines:
- Dedicated Technical Board: Introduce a dedicated technical board that will include representatives from the Ayurveda, Unani, Siddha, Sowa-Rigpa, and Homoeopathy industries.
- Uniform National Implementation: Form a joint consultative committee that will include representatives from the state and central government that will work together to implement the Act in all states in the Indian Union.
- Comprehensive Scope: Expand the scope to include traditional cosmetics and traditional medical equipment.
Core Regulatory Changes at a Glance
- Separate Category Regulations: Dedicated chapters clearly separate rules for pharmaceuticals, medical hardware, and cosmetics.
- Enforcement Measures: Authorizes Drug Inspectors to carry out targeted arrests to stop the circulation of fake or harmful drugs.
- Supply Chain Standards: Mandates certified Good Distribution Practices (GDP) across all retail, wholesale, and distribution networks.
- Clinical Trial Oversight: Sets standards for clinical trials of novel drugs, clinical investigations for medical devices, and performance evaluations for in vitro diagnostics.
- Support for Healthcare Innovation: Creates fast-track regulatory pathways designed to encourage domestic R&D in emerging health technologies.
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