Part 1 of this series appeared in the Jan. 22, 2008, issue of eCliniqua.

Jan. 28, 2008 | Improvements to the airlines and IT infrastructure in India have allowed international clinical research organization (CRO) Quintiles to migrate from the country’s metropolitan areas to smaller cities and towns where equally competent investigators can be found, says Ferzaan Engineer, CEO for Quintiles India. “We move investigators up the experience ladder by monitoring and mentoring them more intensely than we would in an established center.” This has meant investments in training, on-site study coordinators, development of standard operating procedures, and, in some cases, physical infrastructure such as study rooms and computer facilities.

Oversight of clinical trials by the Drugs Controller General of India is “pretty similar” to that of the U.S. FDA, and staffing has been strengthened to deal with the growing number of applications for carrying out clinical trials in the country, says Engineer. Ethical guidelines have been published by the Indian Council of Medical Research.

The regulatory environment may soon get a complete overhaul. A proposal before the Indian cabinet would move the current, under-financed drug authority into a single, larger organization – modeled after the FDA -- that also incorporates other areas of drug development, such as bioequivalence testing, biotechnology, and genetic research.

Schedule Y of India’s Drugs and Cosmetics Act of 1940 was amended in 2005 to make it “globally contemporary,” says Utkarsh Palnitkar, a leader in the policy and investment advisory services of Ernst & Young Private Limited in Hyderabad. “The major amendments…have been the removal of phase lag requirements, thereby enabling concurrent participation in global Phase II and Phase III trials. The requirements relating to the setting up of the ethics committee, formats for informed consent, and reporting of serious adverse events are some other significant amendments. The timelines for approval of a clinical trials application have also dramatically improved.”

	Steve Powell

The country still has a few disadvantages, including a shortage of potential employees with higher-level skills and experience in clinical drug development, says Steve Powell, senior vice president of worldwide sales for electronic data capture (EDC) firm Phase Forward. But they quickly grasp EDC and, relative to their Western counterparts, tend be more teachable as well as grateful for the opportunity to be involved in clinical research.

Quintiles was the first international CRO on the scene in 1997, and now employs 964 people across India in clinical research-related work, much of it in the IT-intensive arenas of data management and drug safety monitoring, says Engineer.. Quintiles has also established a pair of ECG cardiac safety labs in Mumbai and Bangalore, a pharmacovigilance and drug safety monitoring unit in Bangalore, and a Quintiles Central Laboratory in Mumbai. “In 10 years, we’ve done 226 clinical trials across therapeutic areas,” says Engineer.

Phase Forward has just created its own Indian subsidiary, Phase Forward Software Services India Private Limited, based in Hyderabad. Since 2000, Phase Forward has supported several hundred hosted clinical trials in the region and has worked with two major partners in the region. But with so many of the top pharmaceutical firms outsourcing their clinical development work to India, coupled with the push among Indian pharmaceutical companies to become international players, Phase Forward believed “the time was right” to expand its commitment to the region, says Powell.

Current partner Virtusa Corp., a global IT services company, will help Phase Forward incubate the subsidiary by offering infrastructure and IT support, says Powell.

“With the rapid growth of the industry in India…the demand for trained clinicians outstrips the supply,” says Palnitkar. But a number of training institutes have emerged in the public and private sector to augment the “relatively small” number of investigators trained in Good Clinical Practice.

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