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

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

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

Current scenario – Clinical research playersToday there are at least 10 different types of clinical research players

Contract research organizationsSite management organizationsData management – supports EDC systemsBio-availability managementCentral laboratoriesBio-IT solutionsIndependent regional CRA’sIndependent QC firmsCR training institutes

Current scenario – Indian marketClinical 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.

Drivers and ChallengesDrivers 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

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