India is poised to become a clinical research off-shoring hub for the world's leading biotech and pharmaceutical companies. Clinical research organization (CROs) is a nascent industry valued at US$118 million in India with a growth rate of 15 percent. The industry is expected to touch $380 million by 2010, largely due to inflow of multinational companies from countries like US and Europe to India to conduct patient studies primarily to cut cost of drug development.
In India Bangalore is viewed as a perfect locale for trials because of large number of hospitals, availability of medical professional and medical institutions. The leading trials conducted in the city are the kit for testing brain cancer, vaccine for cervical cancer, drugs for diabetes, cardiology, nephrology and neurology to name a few.
Although the development of CRO began in 1997 it achieved prominence only in the last three years. The delayed success of CRO is attributed to the information technology revolution, which attracted all the limelight. The CROs and its operations took a long time to get the necessary exposure and foothold in the industry.
The first entrant in the clinical research space with an intention to conduct clinical trials on the patient population in the country was the US-based Quintiles Corporation. In its formative years, Quintiles teamed up with the Ahmedabad based IV fluid major Core Healthcare to start operations. The Quintiles chief Prof. Dennis Gillings had envisioned a great future for India as the clinical research destination of the world.
India was viewed as an important destination for clinical trails as it has access to patient population with large range of gene pools and disease profiles. Also, the country was known for its medical professionals and healthcare institutions. Clinical trials industry also saw the modernisation of healthcare in the country and inflow of patients from abroad for treatment. The expertise and capability of the Indian doctors were brought to the notice of world. The cost of producing a drug is estimated anywhere between US$800 million to US$1.2 billion, including expenses of approval to patent filing. Global players intend to cut the cost of trails by coming to India, as it is far cost-effective here.
According to the clinical research industry there are around 100 CROs in the country. Notable CROs in the country are PharmaNet, Pharma-Olam International, ClinTec (India) International Pvt Ltd, ClinWorld Inc, GlaxoSmithKline Clinical Data Centre, AstraZeneca Pharma India's Clinical Research wing, Synchron Research, Asian Clinical Trial, (Hyderabad), Axon (Mumbai), Apex (Bangalore), Lambda (Bangalore), ClinInvent Research Pvt Ltd, part of the Purnendu Chatterjee Group, iGates Clinical Research, Wellquest (Nicholas Piramal), Veeda Clinical Research (Ahmedabad), Chilteran (Mumbai), Asiatic Clinical Research, (Bangalore), Excel Trials,(Bangalore), Advanced Clinical Research, Lotus Labs, (Bangalore), Manipal AcuNova (Bangalore), Clinigene International, a Biocon subsidiary (Bangalore), Clintrac International, Wyeth (Bangalore), Triesta Sciences (HCG) (Bangalore), Institute of Population Health and Clinical Research and St. John's National Academy of Health Sciences. A lot of multinational companies like AstraZeneca, Pfizer, Galxo SmithKline and Wyeth are conducting clinical research in India for a range of their products.
Although India's share is a mere 5 per cent of the total clinical studies conducted globally, yet the country is considered to be an important locale for patient study, going by the increasing number of hospitals and the supportive regulatory framework. The country also has well developed pharmaceutical market, growth in the heath insurance and English speaking investigators to interact with US or European companies, making it sought after destination for outsourcing activities.
In terms of investigators, India has about 500-1,000 experts in the country, as compared to 50,000 investigators in the United States. According to the clinical trial majors, there is a serious shortage of investigators in India. To tackle this, Union Government in association with the World Health Organization is conducting training workshops for investigators, ethics committees and pharma companies. The Academy for Clinical Excellence, Mumbai and Institute of Clinical Research India (ICRI) are two of the leading training centres in the country.
ICRI currently operates in Mumbai, Delhi and Bangalore and is supported by excellent faculty drawn from the best in the industry and visiting faculty from Cranfield University, UK. Chennai-based Edutech, a leading provider of enterprise-wide knowledge-solutions has teamed up with the Academy of Clinical Excellence to offer an e-learning programme on clinical research. Jointly they will offer distance-learning project from April 2007.
Bangalore based Vaatsalya Clinical Research provides clinical research consulting services to the clinical trials industry, particularly auditing for GCP/GCDMP, systems development for CROs, site management setup, IRB and Investigator Training. It is also working with multiple CROs (early stage and established) in providing support services in the areas of systems development, documentation, data management consulting, liaison and internal audits. It conducts a six months training program for professionals to join the clinical trials industry, besides several national level workshops.