A vast, unwieldy population, a plethora of diseases, and rampant

A vast, unwieldy population, a plethora of diseases, and rampant poverty was the picture India presented to the outside world until recently. Today, the fact that India has the largest pool of patients suffering from cancer, diabetes, and other maladies is leading the country to become the global hub of outsourcing of clinical trials. Many pharmaceutical companies have set up clinical more trial facilities in major Indian cities. The major advantages apart from India’s huge population of more than one billion and cost effectiveness is the availability of tertiary-care hospitals, high-end diagnostics, large pool of good clinical practice (GCP) trained investigators, and growth in the information technology sector. The largest pharmaceutical companies are also drawn to India because the country offers nearly 700,000 specialty hospital beds.

According to a Confederation of Indian Industry study, clinical trials in India in 2002 generated $70 million in revenue will grow to $200 million by 2007 and anywhere between $500 million and $1 billion by 2010.[3] India is continuing to gain importance as a destination for conducting clinical trials. The global clinical research outsourcing market was projected to reach US $23 billion by 2011, with India cornering 15% of the market by 2013. The rapid growth of clinical trials in India; however, has led to several challenges. The lack of a robust regulatory structure for conducting research and protecting human research participants hinders the advancement of all research (clinical and non-clinical) in India.

Currently, only the sponsors are monitoring or auditing their respective trials; however, there is an increasing need to perform a more detailed review and assessment of processes of the institution and the EC. Robust regulations and guidelines, rigorous training of investigators and research personnel, improvement of health-care and research infrastructure are required for good clinical research. India needs to look at research with a different perspective ?? a comprehensive objective approach ?? in order to protect the interests and safety of human research participants, and to see that the data generated are credible by strictly adhering to the protocol, having a robust consent process, and a thorough review process by the EC. On February 13, 2013, the Drugs Controller of India (DCGI) issued a circular stating that all ECs must be registered under DCGI with 45 days.

[4] Other regulatory authorities, such as the US Food and Drug Administration (FDA), have found the following deficiencies in the conduct of Cilengitide clinical trials: Record-keeping deficiencies, either no or incomplete documentation, protocol deviations, deficiencies in handling and controlling Bortezomib manufacturer test articles, and failure to report adverse events. In India, 43% of FDA inspections have results in a determination of voluntary action indicated.

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