Subpar clinical trials probed in India's review of regulation

Indian lawmakers and patient advocates charge that their regulator rubber-stamped drugs to be sold in the county without required clinical trials. And a parliamentary report heaps blame for poor adherence to trials standards on Big Pharma groups, the national regulator and other stakeholders in a scathing review of approvals in the country.

The investigation probed the approvals of 42 drugs from groups such as the global heavyweights GlaxoSmithKline ($GSK), Novartis ($NVS) and Sanofi ($SNY), finding that certain meds were cleared for the market in India after being banned in developed countries or got approvals without being studied in enough patients, Bloomberg reported. For instance, India's Central Drugs Standard Control Organization approved Sanofi's dronedarone and Novartis' aliskiren based on trials with fewer than 50 patients, allegedly allowing the companies to skirt the minimum 100-patient requirement.

"There is sufficient evidence on record to conclude that there is collusive nexus between drug manufacturers, some functionaries of CDSCO and some medical experts," the report said, as quoted by Bloomberg. "Such irregular approvals spare drug producers the cost and efforts but put Indian patients at risk."

Novartis and GSK, for starters, reacted quickly to the news. Switzerland-based Novartis stated that the company follows the same ethical standards for all of its studies around the world, and has mounted an investigation of its own into regulatory activity in India. In its own defense, GSK got Indian regulators to waive trial requirements for the London-based drugmaker's niche hypertension drug ambrisentan, the London-based drug giant told Bloomberg.

The report is a clear signal that Indian lawmakers and advocates are pushing for tighter control of drug regulation in the country, which has been a rapidly growing market for drug development and pharma sales.

- see Bloomberg's report
- check out Reuters' story