Indian Clinical Trials and First in Human (FIH) Update

With political tensions in China growing and more companies trying to reduce costs, more and more Western drug and device companies will look to do clinical studies in India. While India accounts for close to 18% of the world’s population, its share of the global clinical trials market is less than 2%. Experts believe that the number of Indian clinical trials will grow close to 10% over the next decade.

Before 2013, there were many clinical trials done in India, but many were done without the proper oversight and appropriate regulations.  This led to many problems with Indian clinical trials and many injured participants. As a result of these problematic issues, between 2013 and 2019 the number of clinical trials in India fell by about 85%. However, this trend has begun to reverse itself due to the 2019 New Drugs and Clinical Trial Rules — which now provide more systematic clinical trial regulations and procedures.

The 2019 New Drugs and Clinical Trial Rules include several positive steps forward for clinical trials in India. For example, these Rules include things like – 1. Further detailing the ethical review process, 2. Outlining specific compensation for injuries to patients, 3. Increase alignment with international clinical trials best practices, 4. Provide an expedited approval process with more concrete timelines, etc.

All clinical trials must be registered on the Clinical Trial Registry of India (CTRI). For each stage of a clinical trial, an approval is required. Clinical study applications need to be submitted online via the SUGAM portal which is hosted by India’s governing regulatory body the CDSCO.

Also important for Indian Clinical Trials is the India Council of Medical Research or ICMR. Recently, the ICMR issued guidelines that further outline details on things like informed consent, ethical review procedures, adverse event reporting, post-study reporting requirements, etc. These Guidelines also provide information when doing biological clinical studies, and other clinical investigations like stem cells, children studies, gene therapy, etc.

The CDSCO has also begun to enforce GCP requirements more strictly.

Concerning First in Human (FIH) or Phase 1 studies in India, in the past, they were not allowed for foreign drugs/products if a Phase 1 study had not been done first overseas. However, this FIH policy has now changed and is at the discretion of the trial reviewers, and a FIH trial without a foreign phase 1 study is now possible via the 2019 New Drugs and Clinical Trial Rules. In short, earlier there was a “phase lag” for all drugs discovered outside of India, (which did not apply to drug discovery companies within India). Now FIH can be done first in India and data on previous human exposure is not an essential pre-requisite anymore.

To help facilitate FIH or Phase 1 studies in India, the ICMR helps facilitate clinical research in India. At least 6 tertiary care government-run teaching hospitals have been finalized by ICMR, with more in the works. According to the US FDA in India, more than 200 NIH programs are now in progress for early-stage research.