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Ministry of Health and Family Welfare (MoHFW) | Central Drugs Standard Control Organisation (CDSCO) | Drugs Technical Advisory Board (DTAB)
The Union Health Ministry has notified landmark amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at dismantling regulatory bottlenecks in pharmaceutical R&D. The core reform is the replacement of the mandatory test licence requirement for non-commercial manufacture of drugs with a prior-intimation mechanism. Under this new framework, developers can initiate the manufacture of small quantities of drugs for research, testing, and analysis simply by submitting an online notification to the CDSCO, provided the drugs are not for sale or commercial supply.
Accelerating Drug Development Timelines The amendments introduce specific time-bound efficiencies designed to expedite the clinical research lifecycle:
90-Day Reduction in Timelines: By removing the requirement to wait for a physical test licence, the overall drug development lifecycle is expected to be shortened by at least 90 days.
Reduced Processing Period: For high-risk categories where test licences are still required (such as narcotic or psychotropic drugs), the statutory processing time has been halved from 90 days to 45 days.
Waiver for Low-Risk BA/BE Studies: Prior permission is no longer mandatory for specified low-risk Bioavailability and Bioequivalence (BA/BE) studies; these may now commence immediately following an online intimation.
Mandatory Digital Compliance: All intimations and applications must be filed through dedicated modules on the National Single Window System (NSWS) and the SUGAM portal to ensure a paperless and transparent trail.
What is the “Prior-Intimation Mechanism” in the 2026 NDCT Amendments? The prior-intimation mechanism is a regulatory “fast-track” that allows pharmaceutical companies to bypass the traditional waiting period for a manufacturing licence for research purposes. Instead of a formal application-approval cycle, companies provide a “notice of intent” through the SUGAM portal. Once the system acknowledges the intimation, the company is legally permitted to proceed with drug synthesis for testing and clinical trials, provided they maintain strict records of use and disposal.
What is the "SUGAM Portal" in the context of Indian drug regulation? SUGAM is the central digital gateway of the CDSCO for the filing, tracking, and processing of all applications related to drugs, clinical trials, and medical devices. It enables a paperless regulatory environment where applicants can upload documents, pay fees, and receive digital approvals, ensuring transparency and reducing the turnaround time for industry stakeholders.
Policy Relevance
The 2026 amendments represent a transition toward a trust-based regulatory environment, positioning India as a more competitive global hub for pharmaceutical innovation.
Promoting Atmanirbhar Bharat in R&D: By reducing the cost and time of entry for new drug testing, the policy directly supports domestic startups and MSMEs in the biotech and pharmaceutical sectors.
Resource Optimization: Moving 50% of licence applications to an intimation-based system allows the CDSCO to reallocate its scientific human resources toward higher-risk oversight and complex biological reviews.
Ease of Doing Business (EoDB): The reduction in statutory timelines to 45 days aligns Indian regulations with global best practices, enhancing the attractiveness of the country for international multi-centric clinical trials.
Enhanced National Health Security: Faster development cycles for generics and new molecules ensure that life-saving therapies reach the Indian market more rapidly during public health contingencies.
Relevant Question for Policy Stakeholders: How can the CDSCO implement a robust “Post-Intimation Audit” framework to ensure that the autonomy granted by the new 45-day timelines does not lead to a lapse in the maintenance of Good Manufacturing Practice (GMP) records?
Follow the full news here: Key Amendments to NDCT Rules, 2019