India is trumping China on the volume of clinical research outsourced to the country, according to a new report from the Indian Planning Commission.

The report, issued by the Planning Commission’s deputy chair Montek Singh Ahluwalia and quoted extensively in the Indian media, said there were currently 139 clinical trials outsourced to India by pharmaceutical multinationals while only 98 trials had gone to China.

This contrasts with indications last autumn that China was pulling ahead of India as a preferred location for clinical studies. At the time, there were particular concerns about a domino effect from the dismissal of a High Court challenge by Novartis to India’s Patents (Amendment) Act.

The verdict, which followed the rejection of a controversial product patent application for Novartis’ anticancer Glivec (imatinib mesylate), prompted the company to warn that it would be switching hundreds of millions of dollars in planned investments from India to more hospitable territories over the next few years.

In parallel, a number of drug multinationals, such as Eli Lilly, Sanofi-Aventis, AstraZeneca, Novartis and GlaxoSmithKline, were stepping up their commitment to research and development in China. Favourable costs, a solid medical infrastructure, a large and often treatment-naïve patient population, a national drive for innovation and an improved intellectual property regime were among the reasons cited for this push.

The evidence of a swing in clinical study placement from India to China came from clinicaltrials.gov, the on-line registry established by the US National Institutes of Health. It is by far the largest publicly available registry of clinical trials in the world, although only federally and privately funded studies of experimental treatments for “serious or life-threatening diseases and conditions” have to be lodged there, while registration of other trial is voluntary.

As of last October, clinicaltrials.gov included 287 studies ongoing (either recruiting patients or not yet recruiting) in China, compared with 270 studies in India. In terms of clinical trials that had been completed, terminated or withdrawn, the registry listed 148 for China and 123 for India.

In fact, the latest data from clinicaltrials.gov give a similar picture. China has a total of 703 clinical trials registered, 349 of which are ‘open’ – meaning either in the process of recruiting or not yet recruiting – and 354 of which are ‘closed’ (either active and no longer recruiting or completed, terminated or suspended). India, for its part, has 644 trials listed, 331 of which are open and 313 closed.

What the situation really is

How these figures tie in with those released by the Indian Planning Commission (which did not include any frame of reference) is not immediately clear. As Anthony Woodman, chief executive officer of the Institute of Clinical Research (India), commented at last week’s annual spring conference of the UK-based Institute of Clinical Research (ICR) in Birmingham, one of the problems with India is “knowing what the situation really is”.

The same applies to measurements of the country’s clinical research market, although there is no question the sector is showing vigorous growth – estimated at as much as 70% in 2006/7. The Planning Commission report puts the market value of clinical trials outsourced to India at around US$300 million, with revenues projected to reach US$1.5 – US$2 billion by 2010.

This is significantly larger than the commonly cited forecast of US$1-US$1.5 billion from consultants McKinsey. In Birmingham Woodman suggested the Indian market for clinical research would probably not hit that target, although it still had a great deal of potential, particularly as the country had worked very hard in recent years to put a strong and stable regulatory system in place for the sector.

Also presenting at the ICR conference, Dr Shirali Raina, director, clinical operations India for i3 Research, referred to data from US investment firm William Blair projecting that the clinical research market in India would expand from US$100 million in 2004 to more than US$1 billion in 2011.

That would take the country’s share of a global clinical research market worth US$9.8 billion in 2004 from 1% to 6% in 2011, although some projections actually go as high as 15-20% by 2010.

The Drug Information Association (DIA) has just acknowledged the "meteoric rise" of the biopharmaceutical industry in India by opening a new office in Mumbai and setting up a provisional Advisory Council of India, with a particular focus on building membership and volunteer networks as well as advising on the region's educational needs for training programmes and conferences.

Announcing these initiatives, the DIA noted that the industry was forecast to be worth US$1 billion by 2010, up from US$30 million in 2002, US$60 million in 2003 and more than US$100 million in 2006.

Training gap

The number of Good Clinical Practice (GCP)-compliant studies in India is expected to rise from 250 in 2005 to 1,500 in 2010. To support this kind of growth, Dr Raina added, the number of GCP-trained investigators in India would have to swell from 600 in 2005 to 3,000-5,000 in 2010 and the overall number of clinical research professionals (CRPs) from 2,500 to 30,000.

In fact, McKinsey believes a total of 50,000 CRPs will be needed to drive projected growth in the Indian clinical research market to 2010. The takeaway message is that India has a lot of gaps to fill. The Planning Commission report suggests a shortage of trained clinical research personnel – estimated at anything from 30,000 to 50,000 CRPs – is the biggest challenge facing the country in sustaining an internationally competitive sector.

India needs, among others, more study investigators, auditors, ethics committee members and data safety management boards, the report says, recommending that a Clinical and Medical Research Council should be established with the help of the private sector to formulate, promote and run training programmes.

At the ICR meeting, Woodman said he was not convinced internal training and growth alone would be enough to meet India’s urgent demand for clinical researchers. The country was now seeing the return of some non-resident Indians to home turf, he noted, and it was likely an “element of repatriation” would be needed to fill all of the gaps in the clinical research sector.

The Planning Commission report also highlights infrastructural weaknesses such as a lack of internationally accredited testing laboratories to back up trials. On the plus side are fundamentals like quality hospitals and medical professionals, a large and genetically diverse patient pool, and diseases ranging from heart conditions to diabetes and psychiatric disorders that are also prevalent in industrialised nations.

Inevitably cost advantages fall into this spectrum. According to the report, the cost of running clinical trials in India is 20-60% that in the industrialised world, while clinical researchers, nurses and information technology professionals can be hired at less than one third the wages paid in those countries.

Dr Raina took a conservative view, commenting in Birmingham that clinical trials in India were at best 50% cheaper than in other parts of the world once additional factors such as infrastructure costs had been taken into account. But they still cost “much, much less” than in western markets, she said.