Indian drugmakers have faced compulsory licenses, parochial attitudes about patents and expanded price controls, and government actions. But when citizens in India are unhappy about how drugmakers are acting, they have tools to wield as well, and India's generic giant Ranbaxy Laboratories has just become a target.
An Indian lawyer has filed a lawsuit asking India's Supreme Court to shut down the two manufacturing plants named in the felony plea agreement Ranbaxy Laboratories entered with U.S. authorities last month, according to The Economic Times. The litigation also wants the court to order the Central Bureau of Investigation (CBI) to investigate the U.S. case in which Ranbaxy admitted it manufactured subpar products then hid them from U.S. regulators. The suit filed by lawyer Manoharlal Sharma also wants the court to launch criminal proceedings against executives who were at the company when the fraud was executed. The suit was filed as a public interest litigation (PIL), which can be brought by any citizen of 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.
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. 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.
- read the Economic Times story
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