7.53.3 Status identification The manufacturer shall identify the product status with respect to monitoring and measurement requirements. The identification of product status shall be maintained throughout production, storage, implant, usage and installation of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is ...

7.5.1.1 General requirements The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:— (a) the availability of information that describes the characteristics of the product; (b) the availability of documented procedures, documented requirements, work instructions; and reference materials and refere ...

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 ...