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New Delhi, Nov 6: Concerned over ethical issues and data reliability issues, the Drug Controller General of India’s (DGCI) office, which, earlier this year, had almost decided to allow multinationals to enter into phase-I clinical trials and phase-0 clinical trials by 2009-2010 so that the enormous market potential of the sub-sector could be realised, has taken a pause and done a rethinking on the issue.
Heeding to concerns raised in various quarters, including that of public health groups and the NGO sector, the DCGI office conducted a series of meetings later this year with all stakeholders-representatives of contract research organiastions (CROs), pharmacologists, toxicologists and most importantly, members from public health groups like medicines sans frontiers and decided that the clinical trial sector hasn’t yet achieved level of preparedness required for taking this huge leap.
The main concerns that plague the readiness of the clinical trial sector include reliability, validity and the resulting credibility of the data generated through clinical trials. Although India provides a good sample base in terms of its population diversity, gene pool and disease base, DCGI is concerned that it hardly has a domestic manufacturer of accelerator mass spectrometry, a technique used in the microdosing or phase-0 trials to get information about how a drug candidate is being absorbed, distributed, and excreted in humans. Most clinical trial players also don’t adhere to the global standards of radiolabelling and conforming to other standards of global practices including regular auditing, registration, and record keeping. DCGI officials believe that once a questionmark is raised on the quality and reliability of clinical trial data generated after allowing such trials, even MNCs would refrain from entering Indian market, contrary to expectations.
On ethical concerns, DCGI Surinder Singh said, “Currently the idea of informed consent is vague and new to the clinical trials volunteers in the country. Considering the proportion of illiterate population here, it is highly probable that people would volunteer for the sake of money and might end up hopping from one lab to another, while labs themselves will not have information about which traces of chemical have already entered the subject’s body. This probable trend will prove detrimental both to volunteer’s health and the results of clinical trials”. Singh added that the DCGI office is working on importing software that will enable generating database of volunteer by taking his fingerprints and then interlinking labs across the country to share and...
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