Thanks to its huge, ethnically diverse population, India has become a global hub for clinical trials since it introduced patent protection laws in 2005, lowering research and development costs by nearly two-thirds in phase one phase three trials. But the business has been plagued by regulatory failures, reports India's Mint newspaper.
Ethical committees are required by law for each trial, there are stiff regulations to govern contract research organizations (CROs) and the Central Drug Standard Control Organization (CDSCO) is meant to police the system, the paper writes. But there have been serious lapses in virtually every area.
A parliamentary panel in May found CDSCO to be in collusion with drug companies and doctors, and approving at least one drug every month without conducting clinical trials or seeking expert medical opinion, according to Mint.
And several of the trials that actually have been performed have been dodgy, too. As Mint puts it:
In 2004, doctors at the Bhopal Memorial Hospital and Research Centre (BMHRC), established exclusively for treating the victims of the 1984 gas leak, recruited unsuspecting survivors for clinical trials without their knowledge or consent; 14 participants died during the course of the trials.
Together with the episode in Indore’s Maharaja Yashwantrao Hospital (that Mint reported on 10 October), where 32 people have died in clinical trials between 2005 and 2010, this incident highlights irregularities and ethical violations in some trials conducted by clinical research firms and pharma companies—the dark underbelly of the booming clinical trial business in India.
According to CDSCO, there are an estimated 150,000 people enrolled in clinical trials in India, the paper said. And according to a 2011 Associated Chambers of Commerce and Industry of India (Assocham) report, nearly 100 domestic and multinational pharmaceutical companies are conducting trials in the country--making the business worth some $1.6 billion.