10.As provided in the rules, surrogate marker should be considered as an interim data point and further clinical data should be generated following the approval of the new drug based on surrogate marker consideration that must unequivocally support the patients benefit. 11.Upon receipt of NDA the CDSCO should review the application to determine its completeness within timeline to be prescribed wit ...

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 ...

(xii) Active therapeutic medica I devices for administering or exchanging energy (a) Subject to clause (b), an active therapeutic medical device shall be assigned to Class B, if it is intended for the administration or exchange of energy to or with a human body. (b) An active therapeutic medical device referred to in (a) shall be assigned to Class C, if the administration or exchange of energy may ...

The manufacturer shall establish and maintain a record for each batch of medical device or in vitro diagnostic medical devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved. 7.5.1.2 Control of production and service provision—Specific requirements 7.5.1.2.1 Cleanliness of product and contamin ...

xiii) Active diagnostic medical devices (a) Subject to clauses (b) and (c), an active diagnostic medical device shall be assigned to Class B, if it is intended, — (1) to be used to supply energy which will be absorbed by the human body; (2) to be used to capture any image of the in vivo distribution of radio-pharmaceuticals; or Central Drugs Standard Control Organization, Ministry of Health and Fa ...

(e) An active diagnostic medical device shall be assigned to Class C, if it is intended for the control or monitoring, or to be used to directly influence the performance, of any active diagnostic medical device referred to in clause (d). (f) Subject to clause (g), an active medical device shall be assigned to Class B, if it is intended for the administration, or removal of, any medicinal product ...