New Delhi, Jan. 28 -- The Ministry of Health and Family Welfare has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, in line with PM Modi's directive to reduce regulatory burden and promote 'Ease of Doing Business'.
These amendments aim to simplify regulatory processes, reduce approval timelines, and enable faster conduct of clinical research and pharmaceutical development in India.
Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for the manufacture of small quantities of drugs intended for examination, research, or analysis purposes. Through the notified amendments, this licensing requiremen...