Clinical research is an indispensable part of drug discovery process to
ensure the safety and efficacy of a new drug. Typically it takes 10-12
years and millions of dollars to bring one new drug to the market with a
very limited success rate. In the present IPR regime, patent for a drug
is valid for 20 years of which a significant amount of time is spent in
development alone. This, in turn, is posing a big challenge to the
pharmaceutical/biotech companies (sponsor) worldwide and they have
started adopting outsourcing strategies to optimize their innovations.
With an expectation of recruiting large number of study subjects,
majority of the sponsors have started including countries like India,
China, Russia and Poland for conducting their clinical trials.
Advantage India
A
nation with more than 1000 million people, India has the second largest
population in the world. With an average annual GDP growth rate of 5.8%
for the past two decades, its economy is among then fastest growing
economies in the world. Being a signatory to the World Trade
Organization (WTO) agreements, India has a favourable intellectual
property environment and is fast emerging as a preferred destination for
conducting clinical trials.
India clearly provides an
opportunity in terms of availability of large patient populations,
highly educated talent, a wide spectrum of disease, lower costs of
operations, English speaking population and a favourable economic and
intellectual property environment. India is estimated to have more than
3000 GCP compliant investigator sites and 20,000+ GCP trained clinical
research professionals. A two-tier approval process is followed in India
requiring the trial proposals to be approved by the IRBs at the
institutional level in addition to the approval by the Drug’s Controller
General of India at the country level.
Data suggests a 50-60%
cost saving for conducting clinical trials in India compared to the
same clinical trials being conducted in the US or Western Europe. This
is evident by the steadily increasing number of global studies in India
over the past few years. With major pharmaceutical/ biotech companies
and CROs establishing their presence in India, the country is projected
to conduct nearly 5% of the global clinical trials in next five years.
An
estimate of the total market for conducting clinical trials either
directly or through Contract Research Organizations (CROs) in India till
2010 is projected at US$ 2 billion by major pharmaceutical companies.
ClinicalTrials.gov enlists a total of 1292 clinical trial for India of
which 424 studies are currently in enrolment phase.
Challenges
Like
other developing countries, some key barriers exists in India that
includes limited technical know-how of clinical research, poor
compliance to the regulatory framework, patient’s rights and safety,
conduct of illegal trials, lack of training at the level of ethics
committees, infrastructural challenges etc. However, it is worthwhile to
note that multinational pharmaceutical companies and CRO(s) are able to
conduct good quality clinical trials in India despite all these
hurdles. The only reason they could do so is because of the required
professional training and their willingness to comply with the
regulations and applicable standards in ‘true spirits.’
India’s preparedness
Of
late, several initiatives have been taken by Indian regulatory
authorities to increase the vigilance on the conduct of clinical trials
in India. These include mandatory registration of clinical trials on
Clinical Trials Registry-India (CTRI) as well as inspection of trial
sites by the regulatory agency.
India is now among the very few
countries like Australia, UK, China and US that are making researchers
accountable through public disclosure of their trials. Ever since the
registration of clinical trials has been made mandatory on CTRI (w.e.f
June 15, 2009) there has been a sharp rise in the public disclosure of
clinical trials. The first trial was registered in CTRI on August 29,
2007 and as in May 2010, a total of 1015 trials have been registered
with CTRI.
Mandatory registration of CROs and ethics committee is also expected to follow soon.
Conclusion
Ethical
companies set globally consistent standards and conduct trials only in
the countries where GCP compliance is assured. The foundation of
knowledge-based industries in India was laid down by the information
technology industry and clinical research is fast following the
footsteps to become the next sunrise industry. Indian investigators and
clinical research professionals have already demonstrated their medical
and scientific competence by participating in several global
registration trials as well as by publishing their research work in
peer-reviewed scientific medical Journals of repute. Soon, Indian
clinical research capabilities will become part of clinical development
programmes across the globe.
The author is Director-Clinical Operations,Catalyst Clinical Services Pvt. Ltd