Reproducibility: This section should include reproducibility estimates and information about the studies used to estimate, as appropriate, variability between days, runs, sites, lots, operators and instruments. Such variability is also known as "Intermediate Precision". Reproducibility data is obtained for instrumentation in conjunction with an appropriate assay. Note 1: Such studies should inclu ...

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 ...

5. Clear policy on regulatory requirements, system and procedures is critical for efficient development and approval of new drug through generation of adequate non-clinical and clinical data and their evaluation in transparent and scientific manner for assessment of safety and effectiveness of the new drug. 6. Such policy will not only enhance the public assurance that any new drug approved for ma ...