GLOBALIZATION

By Deborah Borfitz

Nov. 24, 2008 | As part of its broader examination of the clinical research process within its borders, India’s drug regulator may consider changing the rules and regulations governing first-in-man studies of molecules discovered in other nations, according to Shirish D. Sherlekar, head of the life science practice at Mumbai-based Tata Consultancy Services (TCS). Currently, Phase I studies by international companies are limited largely to experimental therapies deemed to have a sufficient amount of safety data approved by the U.S. Food and Drug Administration (FDA) or other regulating body in the drug’s country of origin.

Public discourse on the issue is unlikely before the end of India’s elections in March, notes Debashis Ghosh, vice president and global head of life sciences and healthcare at TCS. Prior to that, a Central Drug Authority bill is expected to be introduced in Parliament that seeks to centralize licensing authority for regulating the healthcare sector, including pharmaceuticals. The bill has separate provisions for medical devices, which are currently undifferentiated from drugs in regulations, as they are by the FDA.

The Central Drugs Standard Control Organisation (CDSCO) itself is being restructured, beginning with its recent move into larger quarters in New Delhi to accommodate a rising influx of trial-related regulatory documents, says Sherlekar. CDSCO has made no secret of the fact that it would like to fully automate operations as well as be a body under India’s Ministry of Health (MOH). At the moment, it reports to the MOH but responds to inquiries from a handful of other ministries.

Some time ago, registration of clinical research organizations (CROs) in India became mandatory, says Sherlekar. All the major international CROs operate here, as well as many small CROs both native and foreign. An official count has yet to be published.

The Indian Council of Medical Research, an agency of the MOH, has been actively working toward establishment of a mandatory clinical trials registry to improve the reliability of data generated and minimize duplication of trials, says Sherlekar. A voluntary registry was launched in mid-2007.

India’s clinical research market has been growing 20 percent annually over the last three to four years and the industry expects the trend to continue at least through 2012, says Sherlekar. The market is currently valued at over $200 million.

Growth in clinical research outsourcing has been happening “simultaneously” in terms of both CRO activity and “functional outsourcing” of specific tasks such as data management, says Ghosh. Even basic research and computational biological work is being outsourced to Indian pharmaceutical firms and drug discovery companies like Advinus Therapeutics, sister to TCS.

India’s strengths as a hub for clinical research include infrastructure and robust training in Good Clinical Practice, says Sherlekar. But due to exponential growth in this industry sector, it will be challenged to keep pace with the demand for clinical monitors and research associates. On the other hand, many institutes have popped up with curricula that “caters to the need.” Companies outsourcing clinical trial work to India have also invested a significant amount of time on education, often using the “train the trainer approach,” Ghosh adds.

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