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.