Regulatory Focus™ > News Articles > Report: India Boosting Ability to Regulate Clinical Trials

Report: India Boosting Ability to Regulate Clinical Trials

Posted 10 April 2012 | By Alexander Gaffney, RAC 

India's regulatory authorities are boosting their ability to enforce regulatory guidelines after years of heightened requirements, reports Outsourcing Pharma.

The Central Drugs Standard Control Organization (CDSCO), which regulates the country's pharmaceutical sector, is seeing an increase in "manpower and infrastructure" to help bring their abilities up their new responsibilities, said Indian Minister of Health and Family Shri Ghulam Nabi Azed.

The Indian pharmaceutical sector has been under heightened scrutiny in recent years. After years of incredible growth after clinical trials restrictions were lifted in 2004, the sector has been hit with news about questionable clinical trials, quality concerns, large fines and patent skirmishes that have spooked western pharmaceutical companies.

CDSCO's announcement also follows one made in January 2012, when Mininister of Science and Technology Vilasrao Deshmukh called for a new emphasis on a "transparent and evidence-based regulatory system."


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