India is fast turning into a global hub of cost-effective clinical research outsourcing (CRO),

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thanks to the adaptation of international regulatory standards. The revenue from this sector is expected to touch $1 billion by 2010.

From $70 million pumped in by just a few pharmaceutical companies to India in 2002, the revenue from clinical research outsourcing has leaped to $800 million now, according to industry insiders.

“In the past two to three years the growth in the sector has been more than 300 per cent. In the past 18 months we found doubling of outsourcing revenue,” said Mahesh Malneedi, CEO and managing director of Makrocare, a Hyderabad-based clinical research organisation.

With a huge population and a plethora of diseases ranging from tropical to nutrition-related and lifestyle diseases, India always had been a prospective place for clinical trials. But the regulations passed by the government in 2005, committing itself to uphold and enforce intellectual property protection as per international standards, has made the US and Europe to look at the country as a preferred destination for CRO, said Selvi Ramesh, director, of Chennai-based Mithas Labs.

Indian Council of Medical Research has been authorised to oversee the trials and there is a Central Ethical Committee as well as local ethical committees to keep a tab on the researches. India has a clinical trial registry as well as clinical good practices formulated.

With international standards in place, the industry has come to a level of maturity, said Malneedi.

Further, the cost factor makes CRO to India appealing as any other outsourcing job to the developed world. “In India the clinical trials for standard drugs could be done for a tenth of the cost in the US and Europe and even for oncology trials it is 50 per cent lesser,” he said adding almost 75 per cent of the costs incurred on a drug discovery is spent on clinical trials.

Globally, there is a pressure on pharma companies to reduce costs on drugs from government agencies. Very few new drugs are coming out and the patents on many of the blockbuster drugs are nearing expiry. “This is pressuring the pharma companies to push as many compounds as possible to the market despite the stringent FDA and regulatory authority demands,” he said.