By Ann Neuer
Aug 4, 2009 | To spotlight its booming clinical trials capability, India staged a major presence at the recent DIA Annual Meeting in San Diego. From the India Pavilion in the Exhibit Hall to dedicated sessions to a special “India evening” featuring representatives from the Office of the Drugs Controller General of India (DCGI), the Indian regulatory agency, the FDA and industry, it was clear that India is positioning itself to be a major player.
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| Dan McDonald |
Dan McDonald, VP business strategy, Excel Life Sciences, a trial management organization focused on India, says the country is en route to being an accepted clinical trials locale. “Two or three years ago, there was a lot of misconception about India. But now, it’s a destination that people consider,” he says.McDonald’s observation is supported by the Federation of Indian Chambers of Commerce and Industry (FICCI), a group that organized much of the India-based activity at DIA. According to FICCI, the percentage of global clinical trials in India is estimated to be 8% in 2009, and forecast to jump to almost 14% by 2011, a 75% increase in two years.
At the India Evening, panelists discussed this growth as part of the country’s vision of making India a global hub for pharmaceutical innovation. Much of this effort is slated to happen through government initiatives aimed at encouraging public-private partnerships. Murali Nair, a partner at Ernst & Young India, explains, “We will shortly be commencing work for the Indian government regarding what should be its focus and role in this effort.”
Each attendee received an elegant information packet about India’s burgeoning clinical trials industry, presented in a lovely bag worthy of a high-end retailer. The most impressive insert was a well-researched booklet developed jointly by FICCI and Ernst & Young India entitled, The Glorious Metamorphosis: Compelling Reasons for Doing Clinical Research in India. This 108-page booklet is a valuable resource for industry stakeholders seeking data about India as a serious choice for placing clinical trials.
Even when armed with data, however, to conduct clinical trials successfully in India, sponsors need to do due diligence, just as they would in any location. As part of this responsibility, McDonald says they are well advised to connect with a partner who is familiar with the Indian clinical trial landscape, including India Good Clinical Practice (GCP) standards. “Sponsors sometimes have had bad experiences if they go it alone. It helps to work with someone who has familiarity with DCGI operating procedures and with whom DCGI is familiar. There is a level of trust in India. Sponsors don’t always realize they should have help,” McDonald points out.
One of the most telling developments that India is a growing force in the pharmaceutical sector is the recent opening of two FDA offices in that country—one in New Delhi, the other in Mumbai—eventually employing a dozen people. The offices provide technical experts and inspectors in regulated product areas such as drugs, devices, and food. Although their responsibilities extend well beyond the realm of clinical trials, the offices are expected to be a major plus in terms of working with Indian government authorities to ensure the quality of clinical research from India coming to FDA.
According to David Lepay, FDA’s senior advisor for clinical science, the new offices are already proving tremendously valuable. “They have provided a communication channel to establish interaction, and over the past few months, we have had a very productive interaction with the DCGI office.” Lepay says the Indian regulators have approached the FDA offices to request help in setting up systems of clinical trials oversight and inspection that are compatible with international standards.
Lepay’s colleague, Bruce Ross, FDA country director India, says it’s best to think of the offices as a portal for FDA to receive and collect better information from India, and for government and industry in India to understand U.S. regulations and guidelines so they understand how to get their products into the U.S.