Thanks to its huge, ethnically diverse population, India hasbecome a global hub for clinical trials since it introduced patent protectionlaws in 2005, lowering research and development costs by nearly two-thirds inphase one phase three trials. But the business has been plagued by regulatoryfailures, a national newspaper reports.
Ethical committees are required by law for each trial, thereare stiff regulations to govern contract research organizations (CROs) and theCentral Drug Standard Control Organization (CDSCO) is meant to police thesystem, the paper writes. But there have been serious lapses in virtually everyarea.
A parliamentary panel in May found CDSCO to be in collusionwith drug companies and doctors, and approving at least one drug every monthwithout conducting clinical trials or seeking expert medical opinion, accordingto the newspaper.
And several of the trials that actually have been performedhave been dodgy, too. As the newspaper puts it:
In 2004, doctors at the Bhopal Memorial Hospital andResearch Centre (BMHRC), established exclusively for treating the victims ofthe 1984 gas leak, recruited unsuspecting survivors for clinical trials withouttheir knowledge or consent; 14 participants died during the course of thetrials.
Together with the episode in Indore’s Maharaja YashwantraoHospital (as reported by the newspaper on October 10), where 32 people havedied in clinical trials between 2005 and 2010, this incident highlightsirregularities and ethical violations in some trials conducted by clinicalresearch firms and pharma companies”the dark underbelly of the booming clinicaltrial business in India.
According to CDSCO, there are an estimated 150,000 peopleenrolled in clinical trials in India, the paper said. And according to a 2011Associated Chambers of Commerce and Industry of India (Assocham) report, nearly100 domestic and multinational pharmaceutical companies are conducting trialsin the country--making the business worth some $1.6 billion.
