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Closing Thoughts on the state of clinical trials in India today.
Several years ago, authors Radhika Bobba and Yamin Khan analyzed the advantages and disadvantages of using India as a preferred location for clinical trials (CT). The article in ACT prompted Neermen Varawalla to comment that there were still many hurdles facing international companies who were willing to consider using India as part of their global clinical development resources. She said that "unless the tacit concerns of the global pharmaceutical industry are effectively addressed, the opportunities in India will remain underused."
The advantages of running trials in India are well-known (large naïve population, plethora of highly skilled, English-speaking health-care professionals, lower costs, etc.). More interesting, however, is the discussion of the obstacles as perceived in 2003 (quality and acceptability of the data, ethics, bureaucracy, lack of patent protection, etc.) and what has been done since to address these issues.
Since 2003, several Indian companies have moved from simply manufacturing generics to becoming world-class R&D companies whose objectives are to develop innovative drugs for the global market. These local companies therefore share the needs of foreign firms to operate under a properly regulated environment, and to develop a competent and well-trained workforce.
Concerns about data validity and acceptability were mostly due to lack of ICH-GCP-trained clinical research staff. There are now numerous public and private organizations, such as the Institute of Clinical Research of India, which propose a one-year degree for aspiring CT professionals. The same can be said about quality assurance with the development of QA firms, both local and international.
The debate on ethics paradoxically has become more troublesome. With increased public awareness of CT activities, the debate has become more political, and one now hears more voices within and outside India criticizing the use of "poor and uneducated Indians as guinea pigs by the International Pharmaceutical industry." Not only is this affirmation false, but it can lead to the exclusion of the Indian population from the benefit of new drug development, and that is unethical. In the recent past, India did lack proper government control of CT activities. This is now being addressed by the Indian Government through the introduction of measures institutionalizing control of CTs in India.
One of the most difficult issues at this time is the increasing negative publicity that the pharma industry in general, and multinationals in particular, receive in India and abroad. In November 2004, the leading Indian biotech journal, Biospectrum, published an article titled "Clinical Trial in the Eye of a Storm." The article analyzed all the incidents that recently undermined public confidence, such as misuse of an NGO to divert trade secrets, conducting clinical trials without authorization, and falsifying consent forms. These issues are not specific to India, and there is no data supporting the view that such incidents occur in India more frequently than elsewhere.
India's bureaucracy is often mentioned as an obstacle. I would argue that requirements by Indian authorities for performing CTs are no more than what FDA or EMEA requires. The problem is only a lack of knowledge by foreign companies of what is required. This is now being addressed by the development of numerous highly competent consultancies and CROs in India who can help foreign companies to better understand the requirements.
Last but not least, the most frequently mentioned problem used to be the lack of patent protection. However, after a protracted debate, the Indian Parliament finally passed the Patent Protection Act in March 2005. This provides protection for patents registered after 1995, while maintaining the rights of local companies. This effectively removes the threat of having generic copies on the Indian market even before the parent drug is approved anywhere else.
India today retains all of its attraction, including an immense reservoir of patients and doctors, and most obstacles have been removed. Patent protection, training centers, and government control have now been put in place, and nothing should stop companies from considering India for their next global drug development program.
When I visited Bangalore last year, I met a 30-year-old Indian man with a PhD from Stanford who had been working for nine years in California. When I asked him why he had come back to take up a managerial position in Bangalore in a leading CRO, his answer was: "Better getting the good jobs here while they are available, rather than wait there for my position to be outsourced to Bangalore." Smart guy!
Jean-Pierre Isal, MD, health care industry consultant