Outsourcing Clinical Research to India

chillibreeze writer — Sahana ghosh

In 1898, Ronald Ross, a doctor of the British Indian medical service, conducted a series of experiments in his personal laboratories during his postings in Ootacamund, Secunderabad and lastly in Calcutta to discover the link between malaria and mosquitoes. In 1899, Ross returned to England and in 1911, he was awarded the Nobel Prize for Medicine.

Tropical diseases have always been chimera for the medical fraternity of the west. A century and a few years later to Ross’s first step to the cure of malaria, multinational companies are drawn to India. Why? The Economist Intelligence Unit explains this as India being the ‘hotspot’ of clinical research based purely on the strength of the presence of a heterogeneous number of diseases in this country. This time, malaria is not the only disease that global pharma majors are testing their drugs for in India. Added to these diseases are now the universal diseases like cancer, AIDS, diabetes and others.
The pharma companies have zeroed in on running clinical research here either through ‘in-sourcing’ – that is, having their own research wings located here – or through ‘outsourcing’- a tendency which has its roots as early as the 1940s. The clinching factor for India’s development as a hub for clinical trials, apart from the large number of subjects (read patients), is the number of highly skilled English-speaking scientists. Like in IT, the skill set of the Indian scientists is greatly favorable for an outsourcing mode.
Various types of pharma research organizations have landed the Indian shores. Some are global contract research organizations (CROs), setting up their data management units in India. Others are IT/ITES companies diversifying to life science data management business.. There are also pharmaceutical companies setting up biometrics and data management operations solely on their own or through partnership among themselves or with the CROs. McKinsey & Co forecasts the investment by global pharma majors for clinical trials in India at $1.5 billion by 2010.

As it is for most outsourced business, cost advantage is the most touted benefit for contract research in the drug industry, similar to that in China, Singapore and Eastern Europe. Rabobank India estimates the cost of trials for a standard drug in India at half of that in the US, which may be a hefty $150 million. According to a Confederation of Indian Industry study, clinical trials in India in 2002 generated $70 million in revenues. It predicts that the revenues would grow to $200 million by 2007 and between $500 million and $1 billion by 2010.

Especially after the government amended the Schedule Y of the Drugs and Cosmetics Act, which now allows simultaneously conducting the same research, except for phase-I clinical trials, in India and abroad, many MNC pharma companies’ R&D units and contract research centers here.

Among the global leaders, Pfizer has a cumulative investment of $13 million in clinical trials in India. This includes trials on 300 patients for a new drug for malaria combining chloroquine and azithromycin, as malarial strains have grown resistant to the former as a stand-alone composition. Pfizer is also carrying out clinical trials for drugs to treat osteoporosis, breast cancer and schizophrenia.

GlaxoSmithKline Plc (GSK) has begun seven simultaneous clinical trials of its vaccine and pharma molecules. Eli Lilly, too, has taken advantage of Schedule Y and now has over 17 large and small clinical research projects simultaneous to projects in other countries, in 40 hospitals across India. The company is focusing on clinical trials for human insulin, insulin lispro, oncology and developing a new molecule for lung cancer. The Swiss pharma company, Roche, has begun clinical trials in India, simultaneously with other locations, for treatment of a new drug for a particular variant of lung cancer. SIRO Clinpharm is currently conducting clinical trial in oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, pediatric diseases and infectious diseases in over 30 hospitals across the country for clients from Europe, Japan, the United States and also India.

Indian pharma companies are not to be left behind in the game. Wellquest, the clinical trials division of the Nicholas Piramal Group, is conducting 40 product tests in five cities. Ranbaxy, India's largest pharmaceutical company has two ongoing collaborative research programs. Hyderabad-based Divi's Laboratories does customized research for Merck, Abbott Laboratories and Glaxo and other firms. Matrix Laboratories, which is actually a bulk drug manufacturer, is now diversifying into outsourced research, which has given it an annual revenue of $10 million, marking a 500% growth. Biocon, which has tied up with Pfizer, AstraZeneca, and Bristol-Myers Squibb, has 300 scientists on its roles, a significant rise from just 25 in 2000.

Besides the pharma companies trying the waters of research by in-sourcing, there are the pure CROs, which mostly provide outsourced services for data management. The main among these are Quintiles in Bangalore, Chennai-based Biomines Research Solutions, Bangalore-based Pharmanet’s (now SFBC International) and Mumbai-based Asian Clinical Trial, ClinInvent and DnO. Bangalore-based Synchron offers complete clinical data management services for data processing, analysis and management.
At one level, the logic of using Indian patients as guinea pigs for clinical research may seem cruel and disgusting. However, in this land of extreme poverty, patients who volunteer for the research get free treatment and can leave any time they want to. Their participation provides them the opportunity to get advanced consultation, which they perhaps would not get otherwise. Companies too willingly spend on enhancing beds in hospitals that are identified for the clinical research, thereby supplementing the healthcare investments in the country. The poor in this country of 1 billion plus people can never have enough of healthcare facilities, whatever the means.

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Sahana writes for Chillibreeze.

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