Clinical Trials for Medical Products in India

In India, medical device approval generally does not require local clinical studies, since foreign data can often be used. Clinical trials in India are typically only required for risky medical devices without predicates.

For new medical devices, local clinical trials in India involve completing Application Form 44, receiving approval from the ethics committee, following protocol and Good Clinical Practices (GCP), and reporting all adverse events. All medical device clinical trials need to be registered in the Clinical Trial Registry of India (CTRI) and will be reviewed by the Medical Device Advisory Committee, which is part of the CDSCO.

In order to register pharmaceuticals in India, clinical trial data must be provided. Foreign clinical trial data is generally accepted, as long as the foreign clinical trial inspection certifies the data complies with Good Clinical Practices (GCP) and the Code of Federal Regulations (CFR).

Rather than conduct a full clinical trial in India, some companies may do an Indian bioequivalence (BE) study instead. The BE study must follow BE and Bioavailability (BA) study guidelines (2005), and the Checklist for Pre-screening Applications (2014). In about 50% of the cases, foreign companies can apply to waive the BE study. Waivers are typically granted based on Finished Pharmaceutical Product (FPP) formulation and marketing status. If a branded drug was approved in India four or more years ago, the bioequivalent drug may be approved without any local studies in India.

The DCGI mandates that all drug clinical trials must be registered with the Clinical Trial Registry of India (CTRI) before the trial begins. Clinical trial registration involves identifying relevant authorities and appropriate patients. Prior to CTRI approval, companies must register with the appropriate Independent Ethics Committees (IEC) and Institutional Review Boards (IRB), submit a dossier to the DCGI, and receive approval from the three-tier review system. Multinational trials that include India must be registered both internationally and in the CTRI. The DCGI announced that Phase III studies done overseas must include at least one Indian participant. The CDSCO accepts multinational studies that involve Indian patients.

Throughout pharmaceutical clinical trials in India, the status of the trial and other key issues must be updated publicly. Review and approval time for all clinical trial applications is about 6 months.