To reduce regulatory burden and promote ease of doing business, the Union Health Ministry has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, enabling faster conduct of clinical research.Industries will no longer be required to obtain a test licence and may proceed with pharmaceutical development after submitting an online intimation to the Central Drugs Standard Control Organisation (CDSCO), except for a limited category of high-risk drugs, including cytotoxic drugs, narcotic drugs and psychotropic substances.Under the existing regulatory framework, pharmaceutical companies must secure a test licence from CDSCO to manufacture small quantities of drugs for examination, research or analysis. The notified amendments replace this licensing requirement for non-commercial manufacture with a prior-intimation mechanism.The Health Ministry said the reform was expected to save at least 90 days in the drug development life cycle, providing a significant boost to pharmaceutical research and innovation. For categories where test licences continue to be applicable, the statutory processing timeline has been reduced from 90 days to 45 days. As CDSCO processes around 30,000 to 35,000 test licence applications annually, the changes are expected to substantially reduce regulatory burden and benefit a large number of stakeholders.In another step to expedite clinical research, the requirement of prior permission for certain categories of low-risk Bioavailability/Bioequivalence (BA/BE) studies has been removed. Such studies may now begin on the basis of a simple online intimation to CDSCO, enabling faster commencement, particularly for the generic pharmaceutical industry. The CDSCO processes around 4,000 to 4,500 BA/BE study applications each year, and the revised mechanism is expected to significantly cut procedural delays.A dedicated online module will be made available on the National Single Window System (NSWS) and the SUGAM portal to allow industry to submit intimations in a transparent and hassle-free manner.