INTRODUCTION 1. A number of communicable as well as non-communicable diseases place heavy burdens in terms of morbidity and mortality, and economic losses, onto the populations and health systems of the country. 2. In order to address the disease burden, it is of paramount importance that safe and effective new drugs are developed and available for prevention and treatment of various diseases. 3. ...

6. However, accelerated approval should be used for a drug that represent significant advances over existing treatment or in case there is an unmet medical need for the indication for which the drug is intended, orphan drug for rare disease etc. in accordance with the provision prescribed under Second Schedule of ND& CT Rules, 2019. 7. ND & CT rules recognize the consideration of surrogate endpoin ...

POLICY ON POST-APPROVAL STUDIES 1. Post-approval studies may be required to provide additional information on the efficacy, safety, and use of the drug in populations more diverse than included in the clinical trials conducted prior to approval of the new drug in accordance with the provisions of the rules. 2. Necessary guidance documents should o be developed to provide the extent of requirements ...

INDUSTRY AND CDSCO COMMUNICATION 1. CDSCO needs to work collaboratively and cooperatively with Industry, academia and others to promote new drug development and to expedite the review process and making the safe and effective new drugs available at the earliest to address various disease burden in the country. 2. CDSCO should be dedicated to ensure that all persons involved in the new drug develop ...