India’s clinical trials hit by ethical concerns
pharmafile | October 12, 2012 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | India, Lunt, clinical trials
India’s clinical trials industry is facing a crisis because of growing concerns about unethical or illegal practices in the sector.
Controversy and legal disputes are threatening to halt growth in trials in the country, according to an in-depth report by Businessworld, India’s leading business magazine.
Activists are organising themselves across the country to challenge what they say are unethical and illegal practices in clinical trials of drugs. They add that illiterate and poor adults and children are being exploited and sometimes tricked into clinical trials without their consent.
Trials are being challenged through public interest litigation (PIL) in the high courts, which seeks to question the way in which clinical trials are conducted and monitored in India.
India’s Supreme Court recently asked the federal government and the states to publish important details about clinical trials being conducted in the country. These include deaths in clinical trials, compensation paid to families of victims and details about the legal framework which regulates trials on humans.
In addition, complaints are now pending before the National Human Rights Commission and various government bodies, including the prime minister’s office, against doctors, sponsors and regulators on non-payment of compensation to people who have allegedly suffered because they took part in clinical trials.
The charges are vehemently rejected by the pharma industry, and according to the report high levels of activism and a surge in litigation, followed by a volley of queries from parliamentarians and a series of media exposés: “Have brought the industry to a screeching halt”.
The publication notes that follow-up enquiries by the health ministry and a resultant freeze in new clinical trial approvals by the regulator, the Drugs Controller General of India (DCGI), have resulted in fewer trials and a loss of business.
Recent analysis by Boston Consulting Group (BCG) cited in the story notes that, in the past five years, India’s clinical trials activity has remained largely flat, putting current market size at $498 million, less than half the $1 billion it was projected to hit by 2011.
Meanwhile, it says that the primarily US and Europe-centric $45 billion global clinical trials market has doubled in terms of the number of registered trials in the past five years, with 64,167 trials registered to date in the US alone.
An estimated 150 firms are engaged in clinical trials in India, including pharma companies conducting their own trials as well as approximately 80 contract research organisations.
Read the BusinessWorld story here
Susie Lunt
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