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 ...

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. ...

POLICY ON NEW DRUG APPLICATION: 1. The content of New Drug Application (NDA) should be designed by the sponsor to answer general question as follows: i. Does the new drug provide a clinical benefit? ii. Is the associated risk outweighing the benefits for the proposed indication? iii. Can the product be manufactured ensuring quality and batch to batch consistency? 2. There should be a system that b ...

Such discussion to help the reviewers becomes acquainted with the information to be included in the NDA. 4. In case the sponsor intends to seek exemption of local clinical trial, clear request for the same should be made in the NDA alongwith rationale and justification and the relevant regulatory provision, under which the exemption is sought. 5. Similarly, in case the sponsor intends to seek app ...

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 ...