3. As per the rules, for manufacture or import of new drugs, the manufacturers/ importer are required to obtain manufacturing/ import permission from CDSCO under the New Drugs and Clinical Trials Rules, 2019 before Licencing the product under the Drugs Rules, 1945. 4. Robust system for evaluation of applications of clinical trial and new drug which contains data of Chemistry, Manufacture, Control (CMC), non-clinical data, and clinical data and other regulatory information is critical to ensure safety and effectiveness of new drugs. 5. One of the recommendations of a committee constituted by the Ministry of H & F.W. for reforming the drug regulatory system in India is that there should be Policy on new drug approval. 6. Accordingly, this document has been prepared to provide policy on approval new drugs in the country.