Skip to main content
Key Points
- India has the largest and one of the youngest populations globally
- Whereas ~400M of the 1.4B population have adequate access to care, ~1B do not…
- By offering access to care as part of a study to those who might not otherwise receive care, study participation becomes a life changing opportunity
- Indian clinicians are ofter trained in the best centers around the world. That combined with the incredible volume of patients they treat make them some of the most skilled globally
- DCGI studies are often approved within 2-3 months provided all paperwork is in order
- Indian centers are highly compliant, so inclusion as part of a US IDE is often accepted by the FDA
- FIH studies in particular are very attractive in terms of cost and time to completion
- FIH can often be combined with a 50-60 patient formal DCGI trial to secure commercial approval in India
- In addition to formal studies, there are a variety of other pathways available to secure FIH data such as prescription or physician lead studies.
- DGI commercial approval is honored in 30+ other countries in SE Asia, Africa and the Middle East.
- When pursuing an IDE for a Denovo or PMA study, it is possible to petition the FDA for inclusion of India data.
- Study and IRB approval are very fast.
- Cost for patient recruitment is typically 90% cheaper than the US.
- Recruitment rates up to 5x faster.
Revenue / Commercialization
- Even if Indian revenue isn’t the immediate goal, India can help shake any bugs out of the product prior to starting a PMA or commercialization effort globally.
- Post Indian commercialization, PHA can help establish and manage a multi-center registry to collect large amounts of real world data.
