India has, lately, been one of the most aggressive sites of clinical research infrastructure-building and growth, likely to conduct 20 per cent of all clinical trials worldwide by the year 2020. The major driver of this growth is the clinical research organization (CRO) industry. CROs are for-profit clinical trials service providers that conduct trials outsourced to them by pharmaceutical companies developing new drugs. India’s CRO industry is clearly in a position to influence regulatory agendas around trials.
The Indian Government is currently considering the legalisation of global Phase I clinical trials. Phase I trials are conducted on healthy volunteers to test the toxicity of an experimental drug, and are different from Phase III trials which are late-stage trials that test the efficacy of a drug in patients already being treated for a disease. Currently India allows Phase I trials only if the drug has already been through this phase elsewhere in the world. These are controversial because of the widely expressed fear that Indians will become “guinea pigs” for foreign companies testing drugs.
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