India winning race with China for Asia's top clinical spot

According to a report released by the Commission´s deputy chairperson Montek Singh Ahluwalia, 139 trials were recently outsourced to India by global pharma companies, compared with only 98 to China. Data provided by the Indian Pharmaceutical Alliance revealed that drug giants GlaxoSmithKline (GSK) and Johnson and Johnson are currently the most prominant sponsors outsourcing clinical research to India, both with 22 studies, followed by Eli Lily and Bristol-Myers Squibb (BMS) with 17 each, Pfizer with 16, Sanofi Aventis with 15, Astra Zeneac on 10, Novartis with nine, Merck with eight and Roche on five. As it continues to attract new business from large pharma players, the market value of India´s clinical research organisation (CRO) industry is blossoming - currently estimated at $300m and projected to rocket to $1.5bn-$2bn by 2010. The Planning Commission data ties in with a newly-released study published by researchers from the Massachusetts Institute of Technology (MIT), who charted the recent trends in the globalisation of clinical trials. ​ India ranked 16th in a tally of the most popular clinical outsourcing destinations with China in only 23rd place behind Brazil, Sweden, Mexico, Hungary, South Africa and Austria. At the same time though, both India and China, along with other countries in emerging regions (Eastern Europe, Latin America, Asia, Middle East and Africa) are still small players when analysed individually, each with less than 2 per cent global share, the data revealed. Eastern Europe and Latin America generally currently host more sites than Asia, although India and China have "grown rapidly from an almost negligible base in just several years​" and their high average relative annual growth rates, coupled with their very low density of trials and current levels of investment in clinical research infrastructure, suggest that they have potential to grow into "major players​" in the future, the researchers wrote. At present India appears to be winning the race in Asia. Commenting on the Planning Commission´s report, chairman of india´s Institute of Clinical Research S R Dugal said several factors had contributed to India's advancement in the field of clinical trials. "India has a vibrant pharmaceutical market and with patient protection in place since 2005​", and this effectively means that companies can introduce drugs in India at the same time as other countries, he said, adding that compared with China, India "strictly follows​" ethical guidelines. In addition, "India has a larger number of doctors with a far better reputation than their Chinese counterparts​," he said. However, according to the report, although the "prospects for outsourcing of clinical research by global pharmaceutical companies look bright, there are a number of problems that need attention​". The main dark cloud hanging over India´s clinical industry is a shortage in trained and experienced staff. "There is a looming shortage of clinical research personnel, estimated at 30,000 to 50,000​", the report said. "We need more trial investigators, auditors, personnel to serve on Ethics Committees, Data Safety Management Boards and personnel in other categories​". Dugal quantified this, stating that at present, clinical trials is taught as a subject by 40 institutes in India, producing 5,000 graduates annually. However, the indistry already needs 11,000 graduates a year to fill present demand and by 2010, will require 50,000 staff specialising in clinical trials. Indeed this problem is already evident on the ground in India. In an earlier interview with Outsourcing-pharma.com, Dr Vasudeo Ginde, president of Indian-based CRO iGATE clinical research said that "by far the biggest problem (in India´s CRO industry) is staff recruitment and retention, and the situation is only getting worse." "More and more pharmaceutical companies and CROs are doing business here and there are only a number of trained and experienced clinical research staff to spread between them,"​ he said. In light of the shortage of trained personnel being the biggest challenge for improving the country's competitiveness, the Planning Commission has recommended that a Clinical and Medical Research Council be established with the help of the private sector to establish and run new training programmes. Meanwhile, the Commission´s report also warned that India is currently being held back by a severe lack of critical infrastructure such as accreditation with international laboratories. In particular, it pointed out that India is lacking a world-class testing laboratory for the validation of tests - although the National Accreditation Board for Laboratories provides accreditation to labs, "it has no international standing​", the report said. "There are weaknesses in the regulatory infrastructure and the Office of the Drugs Controller is understaffed and lacking in capacity to deal with such new areas as stem cell research​".