A Passage to India

WHY INDIA?

India provides a number of significant advantages as a destination for clinical trials. It offers a large patient population, low per-patient trial costs, and a highly qualified professional medical community (many of them Western-trained), as well as global quality hospitals and clinical research facilities. Furthermore, with a highly developed IT and data collection capability and no language barrier, India has become an increasingly attractive destination for clinical trials.

THE BACKGROUND

Until recently, there were few clinical trials conducted in India by Western pharmaceutical and biotech companies, primarily because of regulatory hurdles. Recognising the significant advantages that India offers to multinational companies and the potential benefits of conducting clinical trials in India, the Government made major changes in 1999 with the amendments to Schedule Y of the Drugs and Cosmetics Act. These changes formalised the definition and conduct of clinical trials; specified the responsibilities of the sponsor, the investigators, and the Ethics Committees; developed guidelines and procedures for importing drugs for clinical trials; instituted required compliance with GCP; specified the requirements for informed consent; and defined the structure, content and formats of clinical study reports. In addition, the Indian Government provided increased protection for intellectual property (IP).