India Replaces Test Licence Requirement With Prior Intimation for Early-Stage Drug Manufacture
核心洞察
India amended the New Drugs and Clinical Trials Rules, 2019 via G.S.R. 46(E) dated 20 January 2026, replacing CDSCO permission with prior intimation for analytical and non-clinical testing batches.
CDSCO issued a 23 February 2026 circular granting No-Objection Certificates for new drug laboratory testing immediately on application receipt, removing prior scrutiny of technical specifications.
The Central Government notified an online intimation mechanism for bioequivalence and bioavailability studies of unapproved drugs intended for export, replacing the earlier permission system.
India has moved to a prior intimation regime for the manufacture of small quantities of certain drugs intended for examination, research or analysis, removing the requirement for pharmaceutical companies to obtain a test licence from the Central Drugs Standard Control Organization (搜索).
The change came through an amendment to the New Drugs and Clinical Trials Rules, 2019, notified as G.S.R. 46(E) on 20 January 2026. The amendment applies to certain categories of drugs but excludes certain high-risk categories. According to the Ministry of Health and Family Welfare, the reform is expected to reduce drug development timelines and promote innovation.
Fast-Tracked Testing Approvals and Dossier-Based Licensing
On 23 February 2026, CDSCO issued a circular allowing No-Objection Certificates for laboratory testing of new drugs to be issued immediately upon receipt of applications. Under the revised procedure, NOCs for testing at designated government laboratories are granted upfront rather than after prior scrutiny of detailed technical specifications. The measure is aimed at reducing delays in the drug approval process.
Two days later, on 25 February 2026, CDSCO issued a guidance document for submitting applications for manufacturing licences based on dossier-based licensing. The ministry stated that the dossier-based approach is more efficient than individual evaluation because it streamlines the process and reduces the need for redundant assessment, while promoting transparency and fairness in decision-making.
Bioequivalence Studies for Export Move to Online Intimation
On 21 January 2026, the Central Government notified the replacement of the permission system with an online intimation mechanism for bioavailability and bioequivalence studies of unapproved drugs for export purposes. The change removes prior permission requirements for low-risk BA/BE studies conducted for export. The ministry said the reform benefits manufacturers and the generic pharmaceutical industry by reducing regulatory timelines and procedural requirements.
Pharmacopoeia Update and Certificate Validity
The Central Government released the new Indian Pharmacopoeia 2026 on 2 January 2026. The edition includes several new blood products, vaccines and anti-tuberculosis (搜索) medications. Separately, the validity period for Free Sale Certificates issued by CDSCO to exporters has been made co-terminus with the validity of the Manufacturing Licence.
Reducing Animal Toxicity Testing
CDSCO published a circular dated 29 July 2024 stating that already generated preclinical toxicity data will be accepted for review, part of an effort to minimize the requirement for toxicity studies in animals. The requirement for animal toxicity data in certain cases will be determined on a case-by-case basis, depending on the nature of new claims, the mechanism of action, and non-clinical data already generated with the drug in the approved claim.
Licensing Infrastructure and Delegated Powers
To speed the disposal of applications and licences, CDSCO has issued orders delegating certain powers under the Drugs and Cosmetics Act, 1940 and its rules to officers of the rank of Joint Drugs Controller (India) and Deputy Drugs Controller (India).
The Online National Drugs Licensing System portal, developed by the Centre for Development of Advanced Computing in coordination with CDSCO and State and Union Territory Drugs Regulatory Authorities, provides a single window for online processing of manufacturing and sales licence applications. The SUGAM labs portal has been in place since September 2023 to integrate CDSCO drug testing laboratories, automating the workflow for testing drugs, vaccines, cosmetics and medical devices and tracking testing status.
Inspection and Surveillance Activity
CDSCO, working with State Drugs Controllers, has conducted risk-based inspections of more than 960 manufacturing premises since December 2022. Based on findings, State Licensing Authorities have taken more than 860 actions, including show cause notices, stop production orders, suspension and cancellation of licences or product licences, and warning letters.
More than 1,100 cough syrup manufacturers and 380 blood centres have undergone intense audit in coordination with State authorities, alongside increased market surveillance sampling of syrup formulations by central and State regulators.
Laboratory Capacity and Pharmacovigilance
Under the Centrally Sponsored Scheme for Strengthening of States' Drug Regulatory System, funds totalling Rs. 756 crore have been released to States and Union Territories as the Central Share. Nineteen new drug testing laboratories have been constructed and 28 existing laboratories upgraded.
For post-market surveillance, the National Coordination Centre for the Pharmacovigilance Programme of India at the Indian Pharmacopoeia Commission (搜索) in Ghaziabad collects adverse event reports from Adverse Drug Reaction Monitoring Centres and other stakeholders nationwide. These reports are analysed periodically and safety-related recommendations are sent to CDSCO for regulatory action.
The measures were detailed by the Union Minister of State for Health and Family Welfare, Anupriya Patel, in a written reply in the Lok Sabha.