October 28, 2008

What;s buzzing in the Clinical Research Organization (CRO) industry

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.

To help protect against allegations that clinical trials come to India simply because it is easy to cut corners here, the CRO industry has driven the establishment of a stringent ethical regime which includes institutional review, collection of informed consent from trial subjects, and rigorous monitoring of trials.

But the end-game should be about making healthcare accessible to the vast majority of India’s population. Over the past three decades, the Indian pharmaceutical industry, through its expertise in reverse engineering generic drugs, has already succeeded in making some of the most affordable drugs in the world. India has emerged as “the pharmacy of the developing world”, making vital contributions especially in the global treatment of HIV-AIDS. This success was enabled by a patent regime that allowed process patents on drugs, which has however been replaced by a WTO-compliant product patent regime in 2005. The new patent regime mandates a more stringent protection of intellectual property that favours Western pharmaceutical companies developing novel drugs — thereby curtailing generic companies’ ability to reverse engineer drugs for the twenty year period of the product patent.

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