India

Government 

Federal parliamentary constitutional socialist republic

Capital City 

New Delhi

Official Languages

Hindi and English

Geography

India is bound by the Indian Ocean on the south, the Arabian Sea on the southwest, and the Bay of Bengal on the southeast. It shares land borders with Pakistan to the west; China, Nepal, and Bhutan to the northeast; and Myanmar and Bangladesh to the east. In the Indian Ocean, India is in the vicinity of Sri Lanka and the Maldives. India’s Andaman and Nicobar Islands share a maritime border with Thailand and Indonesia

Demographics
Population:  1,350,485,345  (2018)
Sex Ratio

Ethnic Groups

Indo-Aryan 72
Dravidian 25
Mongoloid and Other Minority Groups 3%

Life Expectancy:
Male: 66.9 years
Female: 70.3 years

Infant Mortality Rate: 34 per 1,000 live births

Diseases with the highest prevalence

  • Ischemic heart disease
  • Chronic Obstructive Pulmonary Disease
  • Diarrheal diseases
  • Cerebrovascular disease
  • Lower respiratory infect
  • Tuberculosis
  • Diabetes
  • Chronic kidney disease

Clinical Research Related Information

Regulatory Authority
All applications (including import license, if applicable) can be submitted in parallel. A global clinical trial having approval in another jurisdiction (e.g., FDA) will take approximately 12 months to obtain all approvals, other studies will take approximately 2- 4 months longer. If Government of India clearance is needed expect substantial additional delay, up to another 12 months.

Ethics Committees
There is no national ethics committee in India. As of February 2013, under the third amendment to the Drugs and Cosmetics Rules, every institution conducting clinical trials in India must have their own Ethic Committee and all Ethics Committees in India must be registered with the Drug Controller General India. The third amendment also sets out membership requirements for ECs and lists documents that are to be submitted for EC consideration of a clinical trial. Guidelines published in 2006 require that ethics committees are responsible for monitoring trials. Monitoring is in accordance with the SOP of the World Health Organization. Under the current (2006) Guidelines, Ethics Committee reviews may occur every 6 months to a year. Under the Drugs and Cosmetic Act (2005 amendment) such review may be used on the periodic study progress reports furnished by the investigators and/or monitoring and internal audit reports furnished by the sponsor and/or by visiting the study sites. Although each Ethics Committee can set their own timeline according to their Standard Operating Procedures SOP. Reviews are generally completed within 3-6 months.

Why India for clinical trials?

  • 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 (lower than Asian counterparts such as China)
  • Established IT infrastructure
  • Adherence to International Clinical Trial Regulations
  • English is a second language