There has been a lot of speculation recently in the Indian and international media regarding the possibility of the US Food
and Drug Administration (FDA) establishing a formal presence in India. Much of this media coverage arose as a result of the
January visit of US Health and Human Service (HHS) Secretary Michael Leavitt and FDA Commissioner Andrew Von Eschenbach to
India.1,2 In his own blog, Leavitt stated that much of his discussion with the Indian Minister of Health and Family Welfare, Anbumani
Ramadoss, centered on regulatory issues.3 Specifically, the talks included assistance to create an equivalent of the FDA in India. In line with the approach used
for China, both HHS and FDA will put teams together to examine the issues.
Faiz Kermani, PhD
In contrast to this description, the media believe that FDA officials will eventually be stationed in India. Although some
may see negative connotations as FDA officials presumably evaluate food safety for US bound products, there is a more positive
angle from an Indian perspective. These developments clearly show that India is maturing as an important pharmaceutical location.
The interest of foreign regulatory agencies may initially be linked to assistance in order to help grow domestic regulatory
expertise and for monitoring purposes, but it must also be in response to India's transformation into a recognized hub for
In particular, the surge in multinational pharmaceutical company-sponsored clinical trials in India must be of interest to
foreign regulatory agencies and such wider issues must have at least been touched upon in top level discussions. Certainly
over the past decade, there has been a perceptible change from skepticism to acceptance in how India is viewed for clinical
trials; many consider it a core region for global plans (Figures 1 and 2). As a result, many global pharmaceutical players
including Pfizer, Novartis, AstraZeneca, Eli Lilly, GlaxoSmithKline, Aventis, Novo Nordisk, Bristol-Myers Squibb, Roche, and
Amgen have expanded their existing clinical research investment and infrastructure in India.4 According to the Asia Times, in 2002, outsourced clinical trials generated an estimated $70 million in revenues for Indian companies in this sector,
and the number was predicted to grow to $200 million by 2007. There are predictions that the Indian clinical trials market
will be valued between $500 million and $1 billion by 2010.5
Figure 1. Major advantages of conducting clinical trials in India
THE EMERGENCE OF THE INDIAN CRO SECTOR
In the early 1990s, the contract research organization (CRO) sector was considered virtually nonexistent in India. Because
CROs were not operating in the country, there was a lack of commercial awareness concerning clinical trials, and to a degree,
this created considerable apprehension in the minds of the prospective clinical trial professionals.4 Pharmaceutical companies that were identified to perform clinical trials were mostly aiding their parent company in regulatory
support and medical marketing functions. In fact, professionally qualified pharmacists and medical doctors interested in pursuing
a career in the industry were not considering clinical research as an attractive career option, preferring a career in pharmaceutical
sales and medical marketing. Only a handful of senior reputed doctors were serving as investigators for global multicenter
studies under the direct monitoring of international sponsors.
Figure 2. Clinical trials in India are on the rise
Attitudes have changed in the last decade, however, as foreign companies that had invested in Indian clinical trials found
themselves pleasantly surprised with the results. In many cases, it was only severe competition elsewhere in the global market
that forced companies to expand their outlook to India. Currently, most local and global CROs consider an operational presence
in India as key to their overall business plans.
To achieve greater economies of scale and increase profitability, there have even been instances where global CROs have reduced
their existing operations in more established markets and expanded similar operations in India. In particular, there has been
a trend to conduct the data management side of clinical trials in India. Hence, to a degree, there has been a steady business
expansion from the US and Europe to India and other emerging market countries. The key enablers for the Indian CRO business
have been the availability of high-quality talented staff, a lower cost of operations, improving infrastructure, growing regulatory
support from the government, and better investor involvement. The existence of well-qualified investigators and other clinical
research professionals means that such business expansion is predicted to continue well into the foreseeable future.