NEW DELHI: To reduce regulatory burden and promote ease of doing business, the Centre has amended the New Drugs and Clinical Trials (NDCT) Rules, 2019, with the aim to boost pharmaceutical research and innovation.
The Union Health Ministry notified the key amendment with the aim to simplify regulatory process, reducing approval timelines and enabling faster conduct of clinical research and pharmaceutical development in the country.
Under the new regulations, pharmaceutical companies are no longer required to obtain a test licence for manufacturing drugs in small quantities for research and analysis, provided they submit an online intimation to the Central Drugs Standard Control Organisation (CDSCO), except in certain cases.
The amendment is in line with the directions of PM Narendra Modi to reduce regulatory burden and promote ease of doing business, the ministry said in a statement.
Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the CDSCO for manufacturing drugs in small quantities intended for examination or research.
This shift from a licensing requirement to a prior-intimation mechanism applies to non-commercial manufacture. However, a limited category of high-risk drugs, including cytotoxic drugs, narcotic drugs and psychotropic substances, will still require formal licences.
This reform, the ministry said, will 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 halved from 90 days to 45 days.