Conditions for permission After grant of permission referred to in rule 52, the following conditions shall be complied with by the applicant, namely:— (i) clinical investigation shall be initiated after approval of clinical investigation plan by the registered Ethics Committee; (ii) clinical investigation shall be conducted in accordance with the approved clinical investigation plan, Good Clinica ...

For clinical investigations conducted in paediatric population, the reviewing Ethics Committee shall include members who are Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 172 of 248 knowledgeable about pediatric, ethical, clinical and psychosocial issues. (iii) Pregnant or nursing women: (a) Pregnant or nursing women shall be included in cl ...

PRESENTATION AND SUBMISSION OF APPLICATION 1. In order to make regulatory review process as efficient for CDSCO as possible, the submission of applications for approval of clinical trials and new drugs to CDSCO ensuring conciseness, correctness, consistency and clarity. 2. A clear well-presented submission facilitates the evaluation process in a timely manner, whereas, a difficult-to-evaluation su ...

As part of design and development validation, the manufacturer shall perform clinical evaluations and/or evaluation of performance of the medical device or in vitro diagnostic medical devices. Note 1 : If a medical device or in vitro diagnostic medical devices can only be validated following assembly and installation at point of use, delivery is not