India, Jan. 29 -- image credit- shutterstock

In line with Prime Minister Narendra Modi's directions to reduce regulatory burden and promote ease of doing business, the Union Ministry of Health and Family Welfare has notified significant amendments to the New Drugs and Clinical Trials Rules, 2019.

These amendments aim to simplify regulatory processes, reduce approval timelines, and expedite clinical research and drug development in the country.

Under the existing regulatory framework, pharmaceutical companies were required to obtain a test license from the Central Drugs Standard Control Organisation (CDSCO) for manufacture of limited quantities of drugs for the purposes of testing, research or analysis.

Through the notified amendments,...