The Indian government is planning to tighten the clinical drug trials regulation by establishing Central Drug Authority to penalize foreign companies violating the norms.
As the US and European drug giants are increasingly outsourcing their clinical testing to the rapidly developing economies like China, India and Africa, the Indian government is planning to enact new regulations to control drug trials in the country by establishing a Central Drug Authority that will keep a check over the activities of these firms, as reported by BNET Pharma.
The market value of the clinical trial research outsourced to India, which grew by 65% in 2006 alone, is expected to climb up to $1.5-2 Billion by 2010 from the present estimated value of $300 Million.
The government’s decision of tightening clinical trials regulation has come after the death of 49 children during clinical testing conducted at the All India Institute of Medical Sciences. Clinical trials refer to the final stage of research to check the safety and efficiency of drugs, vaccines or devices.
The stupendous increase in clinical trials inflow in India is credited to factors such as skilled medical professionals, low-cost services, diverse genetic pool, drug naïve population, large patient pool and world-class hospitals to undertake clinical trials.
The Indian health ministry has charted the Central Drug Authority (CDA) bill that includes enactment of new laws and tightening of existing laws for clinical trials. The bill also has a provision of setting up central licensing mechanism for manufacturing approvals.
The CDA will follow a legal framework for taking appropriate action against companies found guilty of violating norms and conducting trials without permission. India currently lacks a proper legal system to penalize pharma companies that have violated norms and messed up while conducting global clinical trials.
Another key reason for stringent regulations to monitor, audit and legal provision for companies engaged in clinical trials is the high growth in domestic market and India’s emergence as a hub for clinical research. The drug controller’s office receives petitions from at least 25-30 companies per month to conduct testing for the drugs safety and efficiency.
According to a Research Analyst at RNCOS, “There is an urgent need for setting up a central agency to control clinical drug trials in India, so that to achieve a uniform mechanism to interpret and enforce drug laws. At present, the interpretation and enforcement procedure varies from one state to another state, with little accountability in case an issue arises.”
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