India – A Critical Player in Global Clinical Research Dr. Anoop K. Agarwal

What is Outsourcing? Transfer in full or part of the business activities to an outside entity. This may include transfer of – Business Processes – Procedures – Responsibilities

WATERSHED YEAR 2005 Several major events occurred in 2005 making it watershed year. Amendment to Schedule Y Passage of IPR bill Launch of CDSCO/ WHO- GCP training programmes. First USFDA inspection of a global trial Launch of Pharmacovigilance programme Ministry of Health & World Bank (6 centres)

Sponsor Investigator / Site Patient CRO SMO IRB/IEC The Players in Clinical Research Regulators

India - Natural choice for CR services Easy Access of patient recruitment Well-trained medical community to global standards Rapidly increasing awareness of GCP English as a primary language of education and communication 100 million English speaking people (Largest outside US)

India - Natural choice for CR services Right patient pool Genetically & culturally diverse population Treatment- naïve patients from multiethnic and multiracial backgrounds Wide spectrum of diseases Speed of patient recruitment IPR / WTO, GATT on board Cost effective operations Presence of all Pharma majors

Facts & Figures 40 million patients with cardiovascular diseases 35 million with Type 2 diabetes 10 million with psychiatric disorders 2 million cases of cancer with 5,00,000 cases detected every year Recruits for genetic studies

Facts & Figures 600,000 practicing physicians 14,000 hospitals 7,00,000 beds 17,000 medical graduates per year Estimated no. of GCP trials conducted in 2010: 300 – 350 Estimated no. of GCP trained PIs in 2010:

India – Favorable destination for Clinical Trials CR industry will witness a business of Rs 10,000 crore creating a demand of 50,000 professionals in the next 5 yrs ( McKinsey Report) By 2012 up to 5% of global trials will take place outside USA & Western Europe , not > 20,000 patients participated in global trials, estimated that 20% of all patients in global trials could be from India

Projected Growth of Indian CR Industry Resources2012 CR market$1.5 Billion GCP Studies GCP Trained Drs Subjects reqd CR Professionals50000

In preparation for this role … ICMR improving facilities for CT & drug development research -10 yrs – Advanced centers in toxicology, clinical pharmacology, reproductive toxicology, CTs of medicinal plants & herbs. No trial can be conducted in India without the approval of the DCGI Ministry of Environment & Forests to approve genetically modified drugs, before DCGI

Widening Operations of CROs No. of companies participating in CR is increasing Large Indian pharma companies (Wockhardt, Sun Pharma, Lupin) working on NCEs. They have established their own CR units to conduct trials for their new molecules.

Widening Operations of CROs Central / Referral Labs (Dr. Lals Lab, Metropolis Health Services, SRL Ranbaxy) are offering CT services IT Companies (Cognizant, Eassar, HCL, IBM, Infosys & TCS), making investments in Data Management

CROs in India > 250 CROs in India Many pharma Cos. have their own CR Units conducting trials in government & private hospitals. E.g. Eli Lilly is conducting 17 global & local CTs in 65 locations

Clinical Research Market est McKinsey 2003 Assumption USD = Rs. 45 YearIndian market (Rs. in cr.) Indian Market (million $) [% of global] Global Market (million $) [1.16 %] [1.11 %]9, [1.80 %]10, [2.26% of US]26,500 US + Rest [2 %]50,000

3-Year Employment Growth Global Pharmaceutical Industries Source: PhRMA, CenterWatch Aanalysis Growth rate

Staff Distribution in Indian CROs Source: Data on File

Key Qualifications Sought Source: CenterWatch Survey

Changes in Roles & Responsibilities During Past 3 Years N = 1771 Source: ACRP Outlook

Technologies & Clinical Trials Percent of Total Source: ACRP Outlook

Clinical Research-A Regulated Approach ICH-GCP guidelines Indian GCP Schedule Y Biomedical Ethics

New Drug - Indian Regulations New device, Any intervention, Vaccine A drug discovered abroad must be evaluated in India Mandatory clinical trials e.g: HIV vaccine trials

Patent Act opens up vast business opportunities for Indian Companies Positive transformation, will improve nations image in the world Product patents Boost R&D & will help to bring in foreign direct investment in the industry & contribute to healthcare Major opportunity for MNC pharma by launching patented new products India will get an estimated revenue of US $10 billion thru the new patent regime. » Dr. William Haseltine Head - MSAB

There is no second chance ! Clinical research is not a BPO Whether done in Delhi or Dallas, needs the same scientific scrutiny & ethics No short cuts & half measures Because…

Have you seen geese heading south for winter flying along in V formation? As each bird flaps its wings, it creates an uplift for the bird immediately following. By flying in V formation the whole flock adds at least 77% greater flying range, than if each bird flew on its own.

People who share a common direction and sense of community can get where they are going more quickly and easily because they are travelling on the thrust of one another.

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