India was considered as an all-time favoured destination for clinical trials. Most of the outsourced studies are phase III studies where India has a diverse pool of patients. After 2010 there was major setback in the CRO industry in India. Drug Controller General of India (DCGI) approvals were delayed and multinational sponsors stepped back outsourcing studies to India. But slowly post 2016 DCGI has been generous enough in proving approvals and online application system has brought a lot of difference. Indian Clinical Trial market and clinical trial services is expected to grow significantly along with trends.
With 17% of the global population and 20% of the world’s disease burden, India faces a ‘triple burden’ caused by communicable disease, non-communicable disease and socio-behavioral illness. The increasing disease burden is propelling the pharmaceutical and biotechnology industry to bring up new chemical entities into the market at a higher rate. Most companies are outsourcing the clinical trials of their newly developed drugs to various contract research organizations as this could save them the hassles of regulatory issues and patient recruitment burden from the research and development phase.
Making his point on triple burden of diseases, Naz Haji, SVP & Managing Director, QuintilesIMS India said “We have diseases that are close to being eradicated in other regions like cholera and tuberculosis, and at the same time must contend with rising rates of diabetes, cardio-vascular and other lifestyle-related diseases. Despite this high burden of disease, according to www.clinicaltrials.gov, less than 1.4% of global clinical trials are carried out in India and we need to be doing more for our patients. Besides our large population of treatment-naïve patients, India also has excellent site infrastructure, skilled investigators and cost efficiencies.”
Market trends
According to Boston Consulting Group, 48% ($30 billion) of all clinical research investment in 2017 will be spent on outsourced services. India is home to 16 per cent of the world’s population, 20 per cent of the global disease burden, yet it has less than 2 per cent of clinical trials registered worldwide.
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