Few years back, India was considered a global clinical trial hub. The new regulations and guidelines has resulted in a stir among clinical research organisations (CROs) and both multinational and domestic pharmaceutical companies. As a result, India has suffered a series of setbacks. Unclear and problematic clauses that followed have sounded the death knell on trials, with the number of clinical trials slipping to 19 in 2013, as compared to 500 in 2011.
This is bound to affect the number of new drug discoveries in India. The drug companies were earlier drawn to India for several reasons including technically competent personnel, patient pool availability and low costs. But a crackdown began in January last year, when India’s Supreme Court, concerned about allegations of unethical practices and deaths linked to trials. The CDSCO is the national regulatory body for pharmaceuticals and…
