The clinical research industry in India is expected to employ 50,000 professionals over the next five years, according to local trade association ASSOCHAM.

The country is increasingly recognised as a hub for global clinical research, with over 100 domestic and multinational companies conducting trials locally and a clinical research industry worth Rs 80 billion (US$1.8 billion), said The Associated Chambers of Commerce and Industry of India.

Whether India has the human resources to sustain the rapid evolution of its clinical research sector has been a matter of concern for some years now. In 2008, a report by the country’s Planning Commission suggested that a shortage of trained clinical research professionals – estimated at anything from 30,000 to 50,000 CRPs – was the biggest challenge facing India amid global competition for clinical trials.

Among the leading pharmaceutical companies conducting trials in India are Pfizer, Glaxo SmithKline, Aventis, Novartis, Novo Nordisk, Astra Zeneca, Eli Lilly, Dr Reddys, Nicholas Piramal, Cipla and Lupin, ASSOCHAM noted.

Studies are mostly in therapeutic areas such as oncology, endocrinology, traumatology, sports medicine, pulmonary diseases, paediatric diseases and infectious diseases.

As the trade association pointed out, the global outsourcing market for clinical research is estimated at US$45 billion. Further growth in clinical trials is expected to be driven by a “robust pipeline” of looming patent expiries as well as potential expansion of authorised generic strategies and of technology-enhanced generics, ASSOCHAM said.

This year, it added, companies are expected to conduct more than 15% of their global clinical trials in India.

Clear opportunity

“The country clearly provides an opportunity in terms of availability of large patient populations, highly educated talent, wide spectrum of diseases, lower cost of operations and strong patent laws,” commented ASSOCHAM secretary general D.S. Rawat.

In line with World Trade Organisation guidelines, India offers tax concessions for ten years on revenue to companies that make research and development investments in the country, Rawat observed.

According to ASSOCHAM, the introduction of electronic medical records in hospitals has also proved “a major attraction” for international clinical research organisations and multinational companies looking to offshore trials to India.

The trade association's plug for India as a destination country for clinical trials comes amid a resurgence of concern about standards in the sector, particularly around ethics approvals and adherence.