MNCs will have to wait longer for clinical trials

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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 exchange information on volunteer database.

DCGI is also working towards starting auditing and inspection of clinical trials in near future. Such team could consist of a drug inspector, toxicologist or pharmacologist and a field expert (paedetrician, cardiologist or a specialist). Once these protocols are in place, DCGI will open the phase-I sector to MNCs, and allow phase-0 trials, an official said. The country’s 2007 clinical research market is estimated at $200 million and is expected to touch $500 million to $600 million by 2010, said KPMG in a report citing Cygnus Industry Insight January 2008. Other estimates project the market to touch $2 billion by 2012-13.

Currently, Indian laws permit MNCs to conduct phase-II and phase-III trials here. But if the company has conducted phase-0 and phase-I trials in at least two other countries, they can be allowed to do the same here. Domestic companies, however, are allowed to conduct drug trials at all stages in the country. According to DCGI, the time taken to give clearances for phase-I trial is 90 days, for phase-II trial is 45 days and for phase-III is 60 days.

•The DCGI has conducted a series of meetings with all stakeholders, representatives of contract research organiastions, pharmacologists, toxicologists and public health groups

• Main concerns include reliability, validity and the resulting credibility of the data generated. DCGI is also concerned that it hardly has a domestic manufacturer of accelerator mass spectrometry