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The healthcare and life sciences regulatory landscape in India continues to evolve, with regulators increasingly focusing on strengthening enforcement, while seeking to streamline regulatory processes.
This edition of the JSA Healthcare Newsletter highlights key regulatory developments and emerging trends relevant to stakeholders across the pharmaceutical, medical devices, clinical research and food sectors.
Proposal to replace the Drugs and Cosmetics Act, 1940
As per media reports, the regulatory framework governing drugs, medical devices and cosmetics is set to undergo a significant transformation. The Ministry of Health and Family Welfare (“MoHFW”) has proposed the Draft Drugs, Medical Devices and Cosmetics Bill, 2026, which seeks to replace the Drugs and Cosmetics Act, 1940 for the regulation of drugs, medical devices and cosmetics. Most significantly, the proposed legislation contemplates a dedicated regulatory framework for medical devices, including risk-based regulation and enhanced regulatory oversight. Previously, the MoHFW had released a draft Drugs, Medical Devices and Cosmetics Bill in 2022 for stakeholder consultation, but did not subsequently release a revised draft. The proposed Bill therefore represents a significant step towards modernising and consolidating the regulatory framework, which has evolved over the years through several amendments to the Drugs and Cosmetics Act and the rules made thereunder.
Debarment of applicants for falsification of supporting documents
MoHFW, vide notification dated July 30, 2026, has notified an amendment to the Drugs Rules, 1945 introducing a formal framework for the debarment of applicants who submit misleading, fake or fabricated documents or information in support of their applications for a license for the import, manufacture, sale, or testing of drugs.
Presently an applicant submitting fabricated data faces enforcement actions such as rejection of applications and/or cancellation of existing licenses. Pursuant to the amendment, the applicant may also be debarred from filing further applications with the regulator for a specified period of time, thereby jeopardising their operations in India.
Requirements for sterilization of medical devices rationalised
MoHFW, vide notification dated August 14, 2026, has rationalised the regulatory requirements for outsourcing product sterilization to another facility. Under the amended provisions, manufacturers outsourcing product sterilization to another facility holding a valid licence under the Medical Devices Rules, 2017 will no longer be required to obtain a separate loan licence for the outsourced sterilization activity. However, the license number of the sterilization site would need to be declared on the label in the prescribed format to ensure trackability.
Central Drugs Standards Control Organisation clarifies regulatory pathway for globally unapproved new drugs
On August 10, 2026, the Central Drugs Standards Control Organisation (“CDSCO”) vide clarification dated August 10, 2026, has clarified the regulatory pathway for applications seeking permission to import and market new drugs that have not been approved anywhere in the world, where Phase III Global Clinical Trials (“GCTs”) are ongoing or completed with participation of Indian subjects.
The CDSCO has clarified that participation of Indian subjects in a global Phase III trial does not, by itself, create a separate or abbreviated pathway to marketing authorisation in India. Such products remain subject to the regulatory framework for an investigational new drug under the New Drugs and Clinical Trials Rules, 2019 (“NDCTR”). The circular also clarifies that such applications are to be submitted and processed by the investigational new drugs division, and not the new drugs division. Accordingly, sponsors seeking to introduce drugs in India pursuant to a GCT would need to evaluate whether they have sufficient clinical data from the GCT to support the application for a marketing authorisation, or whether additional local trials may be necessary.
CDSCO proposes a single Ethics Committee review mechanism for multi-centre research
On August 6, 2026, the CDSCO invited stakeholder comments on the proposed consultation paper on ‘Operational Guidelines for Single Ethics Committee Review of Multi-Centre Research in India’. Presently, any clinical trial or study that is being conducted across multiple sites must obtain approval from the ethics committee associated with each of the sites, potentially leading to variations in approved protocol and documentation across sites. The proposed mechanism seeks to address the requirement for ethical review of multi-centre research through a single Ethics Committee, thereby reducing duplication in the review process across participating research sites.
The proposal could have significant practical implications for sponsors and investigators undertaking multi-centre research in India, particularly by reducing the time and administrative burden associated with obtaining separate Ethics Committee approvals across participating sites. A single-review mechanism may also promote greater consistency in the ethical assessment of a common research protocol. At the same time, the operational framework will be important in determining the respective responsibilities of the reviewing Ethics Committee and the Ethics Committees or institutions at participating sites, including with respect to site-specific considerations, continuing oversight, reporting of deviations or adverse events, and accountability for participant protection. The final guidelines will therefore be important in assessing the extent to which the proposed mechanism can achieve greater efficiency without diluting site-level ethical oversight.
Food Safety and Standards Authority of India steps up enforcement against misleading claims
As per recent media reports, the Food Safety and Standards Authority of India (“FSSAI“) has significantly increased enforcement activity against food businesses in relation to misleading advertisements, product claims and labelling practices. In August 2026, FSSAI disclosed that it had issued more than 150 notices to food companies in recent months concerning misleading advertisements, false claims and labelling non-compliance. Several food business operators have subsequently undertaken corrective measures, including modifying labels and withdrawing or revising claims.
The enforcement activity has covered claims such as “100%”, “Energy Drink”, “immunity” and other health-related representations. The recent actions indicate that regulatory scrutiny is extending beyond food safety in the conventional sense to the manner in which food products are described, marketed and presented to consumers. Food business operators should accordingly ensure that product claims, brand names, packaging and advertising materials are supported by adequate substantiation and are consistent with the applicable requirements under the Food Safety and Standards framework.
This Newsletter is prepared by:
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Sidharrth Shankar |
Nandini Seth |
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For more details, please contact km@jsalaw.com.
