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India


Fast Facts

  • Capital: New Delhi
  • Economy: World’s 7th largest economy, nominal GDP US$2.182 trillion, Oct 2015
  • Health Expenditure: 5% of GDP, 2013
  • Population: 1.29 Billion, 2014
  • Average Life Span: 65/68 (m/f), 2013
  • Languages: Official Language: Hindi. English is primary language of education and communication
  • Adult Literacy Rate: 74.4% 2014

Health Trends

  • Hospitals run by Government, Charitable Trusts and Private organisations. 
  • Easy access and availability to large treatment naïve patient population with varied gene pool. 
  • India reports 30 million heart patients and two lakh surgeries performed every year. Over 30% of patients with coronary disease, which causes heart attacks in India are below 40 years of age
  • Diabetes mellitus affects approximately 61.3 million Indians - 8% of the nation's population. 
  • Incidence of cancer is 70-90 per 100,000 population and cancer prevalence is established to be around 2.5 million with over 800,000 new cases.
  • Estimated 3-4% of India's population suffers from major mental disorders and about 7-10% of the population suffers from minor depressive disorders.
  • HIV prevalence in India is approximately 0.36 percent, amounting to between 2 and 3.1 million people
  • India suffers from high levels of tropical disease including Malaria, and Tuberculosis where one third of the world’s tuberculosis cases are in India. 
  • Indians are also at particularly high risk for atherosclerosis and coronary artery disease

Clinical Trial Landscape

  • India has 16% of the global population and 20% of global burden of disease.
  • India has a large genetically diverse treatment naïve patient population.
  • There are 45,000 hospitals and 9, 00,000 beds in both public and private hospitals and around 60,000 medically trained professionals (Doctors) passing out every year.
  • Established government and private teaching hospitals and institutions for clinical trial conduct.
  • India is one of the first Asian countries to launch a clinical trials registry.  Registrations of all clinical trials are mandatory.
  • More than 1000 Institutions with registered IRBs. IRBs compliant to ICH/MOH Guidelines, over 2000 ICH/ GCP compliant sites. 
  • More than 1500 investigators in different therapeutic areas across the country have been trained and are experienced in GCP compliant clinical research. 
  • India offers world-class facilities to undertake high-quality, cost-effective, Phase I Bio-availability (BA) and Bio-equivalence (BE) studies. 
  • Successful USFDA and EMEA site inspections with no critical findings. 
  • Numerous sponsor audits in India are testimony to the level of quality of data generated. 
  • Institutional IRB approval process conducted in parallel with the DCGI (HA) review. 
  • Regulatory Environment. Revised Schedule Y (2005) of Drugs and Cosmetic rules (1945) conforms to the ICH-GCP requirements, allowing India to partake in global trials. 
  • Regulatory Approvals take approx. 16-20 weeks. Thorough understanding of the evolving regulatory environment in India, as well as the US FDA, EMEA and other global markets. 
  • Cost per patient for trials in India is approximately 40% to 60% of the cost in Western nations. 

ICON in India

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  • Presence in India since 2002
  • 3 offices - Chennai, Bangalore, and Trivandrum. Home based staff in Delhi and Ahmedabad 
  • 15,000 square foot Central Laboratory facility opened in Bangalore, November 2008 
  • Expertise in a number of therapeutic areas including Cardiology, Endocrinology, Gastroenterology, CNS disorders and Respiratory disorders. Also highly experienced in executing Biosimiliar and Oncology trials which include Follicular Lymphomas; Lung cancers, Breast Carcinomas; Prostate Cancer, Uterine Myoma, Brain cancers, and Venous Thrombo Embolism in Cancer.
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Services Offered

  • Clinical Trial Management.
  • Clinical Monitoring
  • Study start-up Services.  
  • Interactive Voice Response System (IVRS). 
  • Medical Affairs and Drug Safety. 
  • Quality Assurance. 
  • Data Management. 
  • Biostatistics/SAS Programming. 
  • Regulatory Consulting. 
  • Investigator Contract Negotiation and Payment Administration. 
  • Central Laboratory Services:  

- Global technical support
- Fully CAP Accredited
- Lab logistics support
- Seamless global data management support

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