Indian litigation seeks to close Ranbaxy plants

Public interest litigation also asks for probe of officials in India

While Ranbaxy’s cover-up of shoddy manufacturing eventually led to a guilty plea and a $500 million penalty in the U.S., there have never been any consequences in its home country of India. Recent public outrage has prompted a stir among government officials about the matter, but some in the public are taking matters into their own hands.

An Indian lawyer has filed a lawsuit asking India’s Supreme Court to shut down the two Ranbaxy Laboratories manufacturing plants named in the U.S. charges and for the court to order the Central Bureau of Investigation (CBI) to investigate the U.S. case. It also presses the court to start criminal proceedings against executives who were at the company when the fraud was executed, according to The Economic Times. The suit was filed by lawyer Manoharlal Sharma as a public interest litigation. A PIL can be brought by any citizen in India. The lawsuit pointed out that Ranbaxy drugs banned by the U.S. continued to be sold in the Indian market.

“It is not a tale of cutting corners or lax manufacturing practices, but one of outright fraud, in which the company knowingly sold substandard drugs around the world, including in India, Africa and the U.S. while working to deceive regulators,” the PIL reads.

Ranbaxy’s problems were brought to U.S. officials by a whistleblower back in 2008, and the regulatory investigation and actions escalated over a half-decade. That investigation resulted in a 5-year consent decree that Ranbaxy signed last year and then a felony plea last month. But it is only since that public admission in May that outrage has been kindled in India against the drugmaker. In recent weeks, some patients have asked hospitals in India to switch them from Ranbaxy drugs. G.N. Singh, the Drug Controller General of India (DCGI), has said that while India’s laws do not require that it act in the face of actions by foreign regulators, his agency is working on a policy for how to respond to safety alerts by them.

Ranbaxy has made a public statement assuring the public that “all Ranbaxy products currently in the Indian and global markets are safe and effective,” and the government has come out with a statement defending the domestic drug-manufacturing industry. Sharma is unimpressed by the government’s position in the matter. His suit alleges that corruption allowed Ranbaxy’s problems to go unheeded in India, and he is seeking a probe of regulators who oversaw the company.

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