Trial and error

C&I Issue 9, 2009

Everyone wants a piece of India’s booming clinical trials industry, estimated to top $1bn by 2010. But as a gold-rush mentality takes hold, doubts are creeping in. A spate of unfortunate events over the past few years has called attention to the practice of conducting unethical, and even illegal, trials, fueling immense public concern and launching many lawsuits. Currently over 228 US Food and Drug Administration (FDA) approved clinical trials are under way in India. Big cities are the favourite sites for these trials; at the end of 2008, Delhi had 76 trials, Mumbai, 86, Chennai, 50 and Bangalore, 64. 


‘Clinical trials are an important element of drug research, but it is the quality and ethical conduct of clinical trials that’s more important. If one strictly goes by the standards laid down by the Drug Controller General of India (DCGI), there is no question of toxicity or tampering. Many companies are eager to tap the emerging market opportunity, but one cannot cross the line,’ said Ranjit Shahani, managing director, Novartis India.


Novartis India has been conducting clinical trials in India since 1996 and currently has 10 ongoing projects. ‘Given the maturity that is developing in terms of trial practices and the supervised control, with clinical research organisations adhering to strict protocol, training and consent forms, and India’s ICH-GCP (International Conference on Harmonisation- Good Clinical Practice) compliant sites, Novartis is bringing more trials progressively into the country,’ Shahani said.


The same goes for GlaxoSmithKline (GSK), which has concluded clinical trials of a breast cancer drug and another for GSK India’s potential blockbuster cervical cancer vaccine. ‘GSK has witnessed close to a two-fold increase in its clinical trials in India’; up from 16 clinical trials in 2006 to about 31 trials in the country in 2007, said a spokesperson.


Pfizer India, which has around 50 ongoing trials, has come a long way from the first global clinical trial for its parent in 1995. Chandrashekhar Potkar, director, medical and regulatory affairs, Pfizer India, said: ‘We have been conducting clinical studies in India for the last two decades. Our clinical studies are in compliance with applicable national/ international regulatory and ethical regulations and guidelines. We also ensure GCP standards.


’ Pfizer has chosen six cities in the north eastern states of India to conduct clinical trials, and has recently completed a trial on 300 patients of a new malaria ‘cocktail’ drug. Pfizer’s cumulative investment on clinical research in India is believed to be $16m.


Other big pharma companies now active include Amgen, Biogen, Eisai, Roche and Johnson & Johnson, as well as international contract research organisations (CROs) like Quintiles, Covance, PPD, Parexel, Icon, Omnicare and Clintec, and a number of Indian CROs, such as SIRO and iGate.


US-headquartered Quintiles started with a small unit in India seven years ago. It is currently conducting more than 50 clinical tests of oncology, ophthalmology, cardiovascular and other drugs for Western pharmaceutical companies, at more than 100 sites in 30 Indian cities. In Mumbai, Quintiles runs a laboratory that processes electrocardiograms supplied by its researchers worldwide.


US biotech heavyweight Amgen is currently setting up an office in India to conduct clinical trials in the country and form partnerships with local firms, while Eli Lilly has a number of large and small clinical research projects running across India. MSD Pharmaceuticals, part of US-based Merck, is looking at India for R&D purposes and has started with clinical trials, and is progressing upstream towards drug discovery activities. The company is establishing Indian medical and clinical research divisions, which will coordinate research projects with clinical investigators at India’s leading hospitals and universities.


Swiss pharma major Roche has set up clinical trial sites in India as part of its global trials for the treatment of a particular variant of lung cancer. One reason is the vast patient population suffering from this cancer, primarily triggered by the use of tobacco products.


With the global clinical research outsourcing market projected to reach $23bn by 2011, consultancy firm KPMG has forecast that India will claim a 15% share in two years. ‘Cost is a key attraction for multinational firms. In secondtier US hospitals, the cost of conducting a clinical trial is over $20,000/subject, while the cost at a first-rate academic medical centre in India is $1500 to $2000/subject,’ said C. M. Gulhati of medical information provider MIMS.


India’s billion-plus population is another factor in its favour. According to a study by Rabo India Finance, a subsidiary of the Netherlands- based Rabo Bank, India’s huge patient population offers vast genetic diversity, making the country ‘an ideal site for clinical trials’. For example, India has the largest pool of diabetic patients, more than 21m.


Moreover, many in the country’s large poor-patient population are ‘treatment naïve’, meaning they have never received drugs for treatment – a fact that simplifies patient enrollment and trial management. Besides this, the country also offers speciality hospital beds, medical colleges and skilled English-speaking medical personnel.


Quintiles, which controls 14% of the world CRO market, has agreed a deal with India’s Apollo Hospitals Group, the largest private hospital chain in India, that will see the two firms collaborate in opening a $6m Phase I clinical trial unit. The new unit is due to open in early 2010, on Apollo’s hospital campus in Hyderabad, with an initial capacity of approximately 50 beds, which will increase to 100 beds. ‘This new Phase I unit will draw on the existing experience of Quintiles staff in India, including our established cardiology group,’ commented Eddie Caffrey, Quintiles’ senior vice president, global Phase I.


Eli Lilly, which has set up a 50:50 joint venture with Jubilant in Bangalore, is to collaborate on the development of new drugs in oncology, metabolic disease, cardiovascular and diabetes. The two companies already had a five-year drug discovery pact in place since 2006. ‘As in our discovery collaboration, we believe this unique partnership will be a pioneering effort in leveraging the expertise of a global pharmaceutical company like Lilly with the emerging development capabilities of Jubilant,’ said the Indian firm’s chairman Shyam Bhartia. Lilly has more early-stage compounds in its pipeline than it can realistically develop on its own. By partnering with Jubilant, it hopes to increase the number it can bring through development.


There are also revenue constraints for big pharma. By 2020, the Organisation for Economic Cooperation and Development (OECD) territories, excluding the US, will spend 16% of their GDP on healthcare, while the US will spend 21%. In all, they will spend $10 trillion on healthcare, according to a report by PricewaterhouseCoopers (PwC). Pressures are, therefore, increasing on pharmaceutical companies to demonstrate the value of their products or risk coming under pressure to cut prices. The combination of big pharma’s lack of recent R&D productivity and pricing pressure in current major markets puts a premium on cost reductions that can improve margins and the need to tap into growth in new markets.


Big pharma’s total shareholder returns have seen weighted average Total Shareholder Returns (TSRs) fall by 2.4%/year between January 2001 and March 2007, according to PwC. It adds that the pharmaceutical business model is moving away from a fully integrated company structure towards a future where companies use a wide range of outsourcing, partnership initiatives and other contractual and relationship arrangements to create networks of collaboration and discovery. Outsourcing to India is a vital component of this networked future.


The enormous interest of multinationals in conducting clinical trials in India also means a good flow of foreign exchange into the country by way of volunteer fees. Daara Patel of the Indian Drug Manufacturers’ Association said: ‘That should not be a reason for the government to be liberal on clinical trial procedures and expose the people of this country to the danger of being experimented with potentially harmful chemical entities.’ He added that there is an urgent need for the Drugs Controller General of India, the Indian Council of Medical Research and other responsible government bodies to have a close look at the current procedures in the interest of overall public safety.

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