Union Health Ministry Notifies Key Amendments to NDCT Rules, 2019 to Reduce Regulatory Burden and Promote Ease of Doing Business

India, Jan. 28 -- The Government of India has issued a release:

Union Ministry of Health and Family Welfare has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, in line with the directions of Hon'ble Prime Minister Shri Narendra Modi to reduce regulatory burden and promote Ease of Doing Business.

These amendments are aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country.

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 e...