India

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Fast Facts

India is the world’s second most populated country. Over the past decade, India’s attractiveness in the clinical trial sector has grown rapidly with the development of an internationally recognized regulatory system.

  • 3rd largest pharmaceutical market by volume and growing
  • Multilingual, multicultural population
  • Official language is English
  • World-class technological infrastructure.

Health Trends

India’s healthcare system is developing rapidly and expanding to cover an increasing percentage of the large population base. Growth in the pharmaceutical industry is being driven by epidemiological factors, increasing affordability, enhanced accessibility, and rising acceptability.

India has high levels of wage inequity, so while rural areas continue to struggle with infectious diseases and sanitation, wealthy urban areas are seeing an increase in lifestyle diseases including diabetes and heart disease.

High prevalence diseases include:

  • Malnutrition
  • Infectious Diseases
  • Tuberculosis
  • Cancer
  • Diabetes
  • HIV/AIDS.

Clinical Trial Landscape

Clinical trials are reviewed and approved in parallel by; the Drug Controller General of India (DCGI) within the Central Drugs Standard Control Organization (CDSCO) regulatory body, and local or central IECs who are registered with the CDSCO.

The average timeline for regulatory and IEC/IRB approval is ~9 months.

Market Snapshot

1.2 billion people

31.3% reside in urban centers

62.8% literacy rate

India population age breakdown for pharma companies thinking of using a clinical research organization
  • Novotech opened its first Indian contract research organization (CRO) office in 2007

Why choose India for clinical research?

There are many compelling reasons to consider contract research organizations in India for your clinical research:

  • Large availability of trial and treatment naïve patients
  • High disease population load
  • Increasing number of patients in lifestyle disorders segment such as Cancer
  • Highly skilled medical and paramedical staff
  • Cost advantages - even lower than Asian counterparts like China
  • Established IT infrastructure
  • Adherence to International Clinical Trial Regulations.