A group of health activists in India has garnered headlines over a case before the country's Supreme Court which claims that drug developers have been using the poor as human "guinea pigs" for their clinical studies. And a number of drug developers and analysts in the country tell Reuters that as a result regulators have slammed the brakes on green-lighting new clinical studies, raising fears about the future of drug development in the subcontinent.
"The situation was never quite easy in India," ICICI Direct analyst Siddhant Khandekar told Reuters. But as the Supreme Court case has unfolded "the scenario has worsened and getting new approvals has become more time consuming."
Piramal Enterprises says that gaining regulatory approval for a new study--which takes about 28 days in Canada and Europe--now consumes 6 to 8 months in India. As a result, the company says it may do future studies outside of the country, which gained a reputation for low-cost drug studies.
Nilesh Gupta, Lupin's group president, told Reuters that "For NCEs in particular in India, the process is extremely long."
India has had a love/hate relationship with the pharma industry for decades. The country has competed with China to become a major offshore site for drug development, but a variety of horror stories has fed the belief that many of the developers simply look to India as a cheap place to test potentially dangerous medications. Meanwhile homegrown biotechs have been trying to establish themselves as viable developers, a process which has proven to be fraught with difficulties.
- here's the Reuters report