Lawsuits seek tighter regulation of India’s pharma industry

The whistleblower who exposed malpractice at India’s then biggest drugmaker has filed a lawsuit against the government, seeking an overhaul of the country’s weak drug regulatory system.

Dinesh Thakur was awarded nearly $48m in 2013 for exposing fraud by his former employer, drugmaker Ranbaxy, then a major exporter of generic drugs, to the US Food and Drug Administration. The company paid nearly $500m after pleading guilty to violating US drug safety laws and making false statements to regulators.

Mr Thakur has now set his sights on New Delhi’s lax and fragmented drug controls, which he believes allow poor quality medicines to be sold or given to patients in the domestic market.

In a pair of public interest lawsuits — both due to be heard by India’s Supreme Court on Friday — Mr Thakur has petitioned for significant changes to the drug regulatory system to make it more effective and protect patient interests.

Among his requests are more stringent quality tests for generic drugs and the stronger prosecution and punishment of companies found to have produced substandard medicines.

He also wants drug manufacturing licences, currently carried out by individual state authorities where factories are located, centralised under a single, national agency.

“As a country we never paid attention to the quality of medicine we consume,” Mr Thakur said. “For the US and Europe there is a lot of attention being paid because there is a large market, but that same commitment to improving quality doesn’t apply to what sells in India or is exported to Southeast Asia, Africa and Latin America.”

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