Clinical Trials in India - Current Developments

The number of clinical trials conducted in India is still increasing. According to a report created by the Federation of Indian Chambers of Commerce and Industry in co-operation with the consulting firm Ernst&Young, as many as 7% of all clinical phase III studies performed worldwide are already carried out in India. For phase II studies, the percentage is 3.2. In the 15 months preceding the report creation alone, the number of industry-sponsored phase II and phase III test facility increased by 116% (reaching 2.299). This makes India the 12th most active country in this field worldwide (within Asia, it ranks second after Japan). The number of clinical investigators has also gone up by 54% since 2002.

The industry itself is also drawn more and more to the subcontinent. For example, nine of the 15 global pharmaceutical and biotechnological top companies already maintain their own clinical research facilities. Seven of the top 10 CROs (Contract Research Organisations) are already present there, too.

The reasons for the growing number of clinical trials conducted in India named in are among others:

  • An extremely quick rate of patient recruitment with, at the same time, very low drop-out percentages. The former being also due to the large population
  • The disease burden is very high and in many cases congruent with the indication areas targeted by the researching companies.
  • The medical infrastructure is very well developed in the cities, many of the hospitals have a relevant accreditation.
  • The English language is widespread in the healthcare sector, and all records can be kept in English.
  • The government of India has undertaken further measures to adapt the regulatory requirements to the highest international standards.
  • Applications for the conduct of a study are handled in a relatively short time (in most cases within 45 work days)
  • The costs for clinical trials in India are less than half those for clinical trials in Europe or the USA
  • Clinical trials in India are quite well regulated:

The "Central Drugs Standard Control Organization" (CDSCO, part of the "Ministry of Health and Family Welfare" of the Indian government) develops and publishes the standards and guidelines and defines related measures. In its role as a regulatory authority, the CDSCO co-operates with the "Drugs Technical Advisory Board" and the "Drugs Consultative Committee", which provide support on many matters. Unwanted effects are also recorded here. Licensing procedures, inspections and marketing authorisations are within the jurisdiction of the "State Drugs Control Organization".


Compiled by
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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