Review
INDIAN CROs (Contract Research Organizations): CAPACITY AND KNOWLEDGE
P. Balakrishna Murthy, Ph.D., D.Sc.,

The global CRO market was worth US$ 20 billion in 2008. It is growing by about 10 to 15% annually. During the last few years, the Indian economy has
grown exponentially. Much of this is attributed to the growth in service sector. Among the non-IT based service providers, pharma, biotech companies and CROs have recorded significant profits. Indian CROs are the most preferred destination for contract research outsourcing, although China is also in the race. Contrary to the global growth rate, the Indian CRO market is expected to grow by about 50% in this year, as predicted by Frost and
Sullivan- a consultancy company based in Texas, USA (Ledford, Nature, 466, 280, 2010). Many multinational pharma and biotech companies are forging strategic alliances with Indian contract research service providers and drug companies for exploring opportunities from concept/discovery t0 synthesis and FDA marketing approval, covering the entire specturm of research studies including GLP based preclinical toxicity studies.

Under this scenario, the Indian government has chosen to become partner of Organization for Economic Co-operation and Development (OECD). The thirty plus member countries of OECD enjoy mutual acceptance of data of non-clinical health and environmental safety studies generated on crop protection compounds, chemicals, biocides, drugs and pharmaceuticals and biotechnology based substances. India initiated the OECD membership process in 2000. The Government of India, under the Department of Science and Technology, initiated a National GLP program, trained many inspectors with the co-operation of OECD and started certifying Indian test facilities for GLP. This is a significant step forward which will enable Indian laboratories to generate internationally accepted regulatory data, which in turn is expected result in many foreign (as well as Indian) drug, biotech, and chemical companies utilizing Indian facilities.

Following are some of the specific advantages in engaging Indian test laboratories for generation of GLP data:
1. Existence of a National GLP programme and the commitment of the government.
2. Animal health and welfare regulations and the regulatory environment
3. Intellectual property protection
4. IT skills
5. Availability of GMP vendors for the supply of equipment, reagentsetc.
6. Demand for GLP (Good Laboratory Practice) based data by Indian regulators.
7. Availability of talented English speaking scientists with enthusiasm for learning and working within a GLP environment.
8. Time efficient and cost effective
9. Improved logistics.
10. Existence of quite a few GLP certified (by EU countries) facilities in the country with experience in submitting GLP based test reports to the EU and US.

The most important advantage lies in the fact that India annually produces 1,500 new Ph.D graduates in the biosciences and about 150,000 Masters degrees in chemistry. New initiatives by the government of India to start many publicly funded,autonomous research Institutions, similar to IIT's (Indian Institute of Technology), are going to multiply these numbers many fold. Also, many of these fresh scientists are willing to take up a career in CROs, contrary to the situation existing years ago, when all post graduates and Ph.D holders use to seek jobs in publicly funded
Institutions such CSIR (Council of Scientific and Industrial Research), ICMR (Indian Council of Medical Research), ICAR (Indian Council of Agricultural Research) and others. India is thus emerging as a strong market for CROs. When it becomes a full member of OECD, the market will boom to such an extent that we must seriously consider increasing our resources.

The author is the Director of International Institute of Biotechnology & Toxicology, Padappai-
601301, Kancheepuram District, Tamil Nadu, India
Tel No. +91-44-27174246 / 27174266; Fax No.+91-44-2717 44 55
E.mail: iibatindia@yahoo.com
By Dr. PV. Mohanan, Indian Correspondent, WLT: Posted on 21 August 2010