India

DCT Feasibility Assessment India The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimers ...

This workbook provides an overview of the current and proposed regulatory landscape applicable in India in relation to Decentralized Clinical Trials (“DCT”). India abides by the regulations set forth by the Central Drugs Standard Control Organizat...

2.1 Name of Regulatory Authority  Medicines are regulated in India by the Central Drugs Standard Control Organization (CDSCO). https://cdsco.gov.in/opencms/opencms/en/Home/ 2.2 Name of Ethics Committee  India has a d...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.   Each EC has its own application form and process. The documents required for submission ...

4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.  The data required will depend upon the type of application, phase of the study, stage in th...

5.1 Does local regulation require PI/CI to be approved/registered by any health authority (e.g., RA/EC)?   No , the PI must be a suitably qualified physician. There are no requirements for approval other than what is required by good...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment. Please refer to Section 2.7 of this guidebook. 6.2 Does local regulation require any separate consent for biological specimen collectio...

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? There are no regulations preventing the conduct of a DCT. 7.2  Is there any specific ...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Data protection in India is currently regulated by the IT Act . The “Sponsor,” or any other person on its ...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ?   Yes , online advertisement is allowed. Facebook is the most eff...

10.1 Clinical Trial with Investigational Medicinal Product 10.2 Pediatric Investigation Plan A PIP (or equivalent) is not required in India. Trials involving children are reviewed and approved in the same way as other clinical studi...

Central Drugs Standard Control Organization (CDSCO) About CDSCO , CDSCO. National Institute of Allergy and Infectious Diseases (NIAID) India ,  NIAID. Indian Council of Medical Research (January 2017) Handbook for Applicants & R...

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