The New Drugs and Clinical Trials (NDCT) Rules - 2019, are India’s regulatory framework for approving new drugs, conducting clinical trials, and overseeing ethics and safety in biomedical research. They were introduced to streamline processes, enhance transparency, and align with global standards.
What are NDCT Rules?
- Issued by - Ministry of Health and Family Welfare, under the Drugs and Cosmetics Act, 1940.
- Implemented By - The Central Drugs Standard Control Organization (CDSCO)
- Effective from - March 19, 2019
What are the new amendments to NDCT Rules (2025)?
- Simplified BA/BE Study Applications
- Test License Streamlining
- Regulatory Alignment with Global Standards
Know more about NDCT Rules,
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