At the last count, medical trials in India were worth well over half a billion dollars and could pass $1 billion in the next three years. How does this stack up with the recent reports of a freeze on clinical trials applications in the country and widespread stories of patient safety being put at risk?
The Indian Supreme Court has recently taken measures to help ensure the safety of patients in new drug trials. Responding to numerous allegations of citizens being used as uninformed “guinea pigs,” the court has blocked many trials that had already received government approval.
In 2011, an investigation carried out by UK newspaper The Independent highlighted the recruitment of hundreds of girls for a study without parental consent, the use of survivors of the world’s worst poisonous gas disaster without proper informed consent, and tests that a police investigation found violated ethical guidelines. This is only one, albeit high profile example.
The Indian health ministry has now put in place a system to scrutinise applications for clinical trials. Industry is supportive of a more transparent system but with reservations over impact on current development work. The timescale for approvals has become more unpredictable and such uncertainties can certainly take the gloss off a prospective trial location. A process that used to take 12 to 16 weeks could now take – well, that’s anyone’s guess!
But what cost patient safety?
Good Clinical Practice gives prominence not just to the scientifically responsibility of the trials but also the patient themselves – with robust rules over informed consent. Is there really room for trials that don’t adhere to these core principles?
Will tighter regulation see a surge in Indian trials or spell the end of India as a relatively cheap way to test new drugs. Perhaps I’m naive but I certainly hope that the Indian trials sector becomes invigorated rather than stifled by tighter controls.
Either way, nothing is going to happen until the log jam of approvals begins to clear.
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