1. Why companies saying or should say “YES” to India for Studies

2. Clinical research at earlier phase  New Business  Regulatory environment and process was not formulated  Pharma companies managed regulatory work at their own  Not even a single CRO or SMO  Less awareness about clinical trials among physicians and Industry  Only a handful of senior doctors represented investigators participating in global multi-centric trials

3. Current scenario – Regulatory environment Formation of Expert committee and conducting advisory committee meetings Pendency status of application The recent amendments in schedule Y Introduction of Rule 122DAB ­- Specifying the procedures for payment of compensation to the subjects of the trial in cases of injury or death Introduction of Rule 122DAC – Specifying various conditions for conduct and inspection of clinical trials Introduction of Rule 122DD - Specifying the detailed guidelines for registration of Ethics Committee Audio-Visual Recording of Consent

4. Current scenario – Clinical research players Today there are at least 10 different types of clinical research players Contract research organizations Site management organizations Data management – supports EDC systems Bio-availability management Central laboratories Bio-IT solutions Independent regional CRA’s Independent QC firms CR training institutes

5. Current scenario – Indian market Clinical trials market in India was valued at INR 1 bn in 2013 and is estimated to reach 18 bn by 2018. Clinical trial market in India has the potential to become the hub for conducted major global multinational global trials. India has large genetic pool and has a large number of patients suffering from acute chronic diseases. India has 16% of world population and 20% of the global burden of the disease. There are 60000 doctors, 45000 hospitals and 900000 beds in both public and private hospitals with electronic medical record facilities in most of them.

6. Drivers and Challenges Drivers  Cost effectiveness  Vast patient population with diverse number of diseases  Increasing R & D expenditure by pharma companies  Sound medical infrastructure  International quality standards Challenges  New regulations have brought in several challenges  Delays in trial approval  Shortage of research professionals  Challenges of unethical trials  Media and public awareness

7. Thank you