CDSCO - Guidance for Industry - Central Drugs Standard Control ...

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Guidance for Industry Central Drugs Standard Control Organization Page 2     Guidance for Industry on Submission of Clinical Trial Application for Evaluating Safety and Efficacy (General considerations for conducting Clinical Trial as per Drugs and Cosmetics Act 1940 and Rules 1945) Document No. - CT/71108 Version – 1.1
Guidance for Industry Central Drugs Standard Control Organization Page 3   OBJECTIVE This Guidance has been developed in conformity with Drugs and Cosmetics and Rules there under and GCP Guidelines of India for the purpose of submission of Clinical Trial application. The clinical trial sponsor is required to submit application (Form 44) for the purpose of conducting clinical trial in India and submit documents as per Schedule Y of the Drugs and Cosmetics Act 1940 and Rules there in. The sponsor is also responsible for implementing and maintaining Quality Assurance system to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and Good Clinical Practice Guidelines issued by CDSCO, Directorate General of Health Services, Govt. of India as well as all applicable statutory provisions of Drugs and Cosmetics and Rules there under. Standard operating procedures should be documented to ensure compliance with GCP and applicable regulations. Sponsors are required to submit a status report on the clinical trial to the Licensing Authority at the prescribed periodicity. In case of studies prematurely discontinued for any reason including lack of commercial interest in pursuing the new drug application, a summary report should be submitted within 3 months. The summary report should provide a brief description of the study, the number of patients exposed to the drug, dose and duration of exposure, details of adverse drug reactions, if any, and the reason for discontinuation of the study or non-pursuit of the new drug application. Any expected serious adverse event (SAE) occurring during a clinical trial should be communicated promptly (with in 14 calendar days) by the Sponsor to the Licensing Authority and to the other Investigator(s) participating in the study. The manufacturer / sponsor have to submit application on Form 44 for permission of Clinical Trial under the provisions of Drugs and Cosmetic Act  
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  © Central Drugs Standard Contr
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