Dinesh Thakur's decision to blow the whistle on India's Ranbaxy Laboratories for faking testing data on the generic drugs it was producing opened the FDA's eyes to shortcomings in its oversight, while making him a rich man. Now, Thakur is prodding his own country's regulators with a legal action that says they have failed to ensure Indian drug manufacturers are making safe and effective drugs.
Thakur's Public Interest Litigation (PIL) lawsuit is slated for a hearing before India's Supreme Court on Friday, Reuters reports. It names India's health ministry, the Drugs Consultative Committee and the Central Drugs Standard Control Organization (CDSCO). If successful, it wouldn't lead to them being penalized, or him collecting any money. It would push the government to create national standards and a process for recalls in a country where pharma oversight is mostly handled by each state under varying standards.
In his suit, he alleged that an "overwhelming number of non-standard-quality drugs are not prosecuted in criminal cases, since state drug controllers only impose minor administrative penalties on the offenders."
Thakur was working at India's Ranbaxy Laboratories, India's largest drugmaker and major U.S. supplier, back in 2007, when he informed the FDA that the drugmaker was not being honest about its testing procedures and the quality of the drugs being shipped to the U.S. His revelations led to a consent decree against Ranbaxy, which in 2013 paid the U.S. government $500 million to settle litigation. It also led to a sale of Ranbaxy to Sun Pharmaceutical, which is in the process of consolidating the companies, even as it deals with FDA concerns at former Ranbaxy plants as well as some of its original manufacturing sites.
Thakur collected $48 million for his whistleblower role. He then opened his own Florida-based consulting firm to help companies, particularly in India, to meet the FDA's more rigorous compliance standards that have resulted in many of India's largest drugmakers having to upgrade processes and procedures at plants that ship products to the U.S.
It is his contention that the Indian government should do more, not only to help the industry avoid FDA sanctions but to improve the quality of drugs used by Indians. For example, 44 Indian plants are banned by the FDA from shipping to the U.S. because the agency found problems in manufacturing, but those same plants can sell their products in India, Reuters reports.
But Thakur's suit has not resulted in warm feelings about him among regulators. The head of the CDSCO, G.N. Singh, told Reuters: "We welcome whistleblowers, we have got great respect, but their intentions should be genuine, should be nationalistic. … I don't have any comment on this guy."
- read the Reuters story