The Union Ministry of Health and Family Welfare has introduced important changes to the New Drugs and Clinical Trials (NDCT) Rules, 2019. These changes aim to reduce regulatory hurdles and make it easier to do business in the pharmaceutical sector. Previously, companies needed a test licence from the Central Drugs Standard Control Organization (CDSCO) to make small amounts of drugs for research or analysis. Now, this has been replaced by a simple online prior intimation process, except for a few high-risk drugs like cytotoxic, narcotic, and psychotropic substances. A senior Health Ministry official said, “As a result, the industry will no longer be required to seek a test licence and may proceed with pharmaceutical development upon submitting an online intimation to CDSCO.” This change alone can save at least 90 days in the drug development cycle, giving a big boost to research and innovation. For drugs that still require test licences, processing time has been cut from 90 days to 45 days. The Health Ministry noted that CDSCO handles 30,000 to 35,000 test licence applications yearly, so the changes will ease the burden for many stakeholders. Additionally, the Ministry has removed the need for prior permission for certain low-risk Bioavailability/Bioequivalence (BA/BE) studies. Now, these studies can start after a simple online intimation to CDSCO, speeding up the research process, especially for generic drug makers. CDSCO processes 4,000 to 4,500 BA/BE study applications every year, and this change will reduce delays significantly. To help implement these reforms smoothly, online modules will be added to the National Single Window System (NSWS) and the SUGAM portal, making the submission of intimations clear and hassle-free. The Health Ministry said these reforms will benefit the pharmaceutical industry while keeping public health safe. They promise faster starts for studies and testing, better use of CDSCO’s manpower, and faster approvals overall. The Ministry added that these steps align India's rules with global standards and strengthen its spot as a prime location for pharmaceutical research and development.