If mortality rates in India due to clinical trials of new drugs are higher than global average, the solution is a foolproof regulatory system, aided by the necessary infrastructure rather than a forced abandonment of this lucrative business that has huge spillover benefits in healthcare. Expenditure on clinical trails accounts for a major chunk of the global drug-discovery spending (average spend is pegged between $500 million and $1.3 billion). Cost-saving measures are increasingly the norm in this area given the drying up of new drug pipelines that has inflated the per-drug discovery cost of drug companies.
McKinsey had projected a few years ago that India would enrol 1,500-2,000 healthy volunteers/patients for various stages of clinical trial by this time; the actual enrolment is just around 250. Reports pegged India?s clinical trials market at $2 billion by 2011. The business in India is worth just $400 million, reporting flat growth at best, while globally this is a $75 billion enterprise growing at not less than 10% annually. China, South Korea and even Singapore are reporting much higher growth, even as they cannot claim to have all the advantages that India has, diversity of the gene pool being one. FE reported on Monday that not only foreign drug majors, but even Indian companies are now opting to do early-stage (phase-1) clinical trials in Europe, Canada and elsewhere.
The reasons cited for India?s under-performance are many?lack of regulatory clarity, competence and infrastructure; reports of surreptitious trials, resultant high mortality rates and backlash against them; the perceived risk that priceless data on new drugs could be leaked here and so forth. Further, there are hardly enough certified trial sites here while poor quality of Contract Research Organisations (most of them not compliant with ICH/WHO good clinical practice standards) is another problem. The situation can be salvaged only if the entire gamut of regulation of clinical trials is upgraded?right from the phase-1 and the other two pre-marketing phases, phase-2 and phase-3, to adverse drug reaction monitoring in the post-marketing stage. We have the laws and regulations in place but not the equipment at the human and material levels. Given the size of this business, India cannot afford to lose its fair share of these outsourced trials.
