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. 
