Whistle-Blower of Unsafe Medicines Takes on `Made in India'

  • Dinesh Thakur sues government in India to overhaul regulation
  • India is the second-largest drug exporter to the U.S.

The man who helped U.S. prosecutors reach the largest safety settlement ever with a generic-drug company is now trying to take on the entire pharmaceuticals industry in India, which he alleges makes unsafe medicines and sells them worldwide.

Dinesh Thakur, the whistle-blower who helped the U.S. government show systemic product-testing failures at Ranbaxy that led to the $500 million settlement in 2013, says poor-quality manufacturing is a problem at many more companies in India, the second largest supplier of over-the-counter and prescription drugs in the U.S. Frustrated by a fractured oversight system and the lack of progress even after the Ranbaxy case, Thakur is now suing the Indian government to force an overhaul of the industry’s regulation.

“For the last two and a half years I have been trying to talk to the Indian government to tell them they need to pay attention to this,” said Thakur, a self-proclaimed public-health activist who previously spent more than 20 years at U.S. and Indian pharmaceutical companies, including Ranbaxy. “They keep saying, ‘There’s really no problem with the medicines India produces.’ I just got tired of it.”

Thakur filed two petitions in late January that will have an initial admission hearing expected Friday before the Indian Supreme Court, claiming that the government has illegally approved existing drugs for new uses, and that poor regulation allows the sale of sub-standard drugs that could cause unnecessary deaths and contribute to antimicrobial resistance. Petitioning the Supreme Court isn’t unheard of in India, where petitioners have obtained judgments requesting better regulation of blood banks and improved equipment and care at health centers and government hospitals. Still, reform, if it happens, could take years, according to Thakur.

G.N. Singh, the drugs controller general of India, said he will not comment as he is not aware about details of specific allegations, and the regulatory body will respond as and when the court asks it to do so. In general, the agency has implemented regulations to ensure drugs fulfill safety and quality standards, he said by phone.

Settlement Money

Whistle-blowers in the U.S. often are entitled up to almost a third of a settlement collected by the government. Thakur, 48, spent some of the $48 million he received to prepare his petitions against the government. The data he obtained from filing information requests helped him outline a drug licensing system that counts 37 regulators -- the central government and 36 states or union territories. In the petitions, Thakur is asking the government to centralize regulation and improve information sharing.

“It’s a very significant issue and it is something that needs to be addressed in India and some kind of a legal action is appropriate,” said Peter Berman, a global health professor at the Harvard T.H. Chan School of Public Health and co-coordinator of the school’s India Health Partnership. “There has been a process in India to try to strengthen the regulatory capacities within the government to do this properly. States don’t always have equal concern and intensity for this issue.”

Thakur worked at Ranbaxy from June 2003 and April 2005 as director and head of research information and portfolio management, where he gained access to the data that led to the settlement with the U.S. Department of Justice, according to the petitions. After unsuccessfully attempting to confront management, he resigned and worked with the U.S. Food and Drug Administration as a confidential informant until 2007, according to the petitions.

Thakur also contributed some of the settlement money to charities, including CanKids, for kids with cancer, and to educational causes, including his alma mater, the University of New Hampshire. He founded Medassure Global Compliance Corp., a Madeira Beach, Florida-based company that helps drugmakers comply with U.S. standards. In addition, he has given talks and written opinion pieces to increase awareness of pharmaceutical regulation in India.

Drugs Banned

Changes in India could have an impact far beyond its borders. The country supplies 20 percent of global generic medicines market exports in terms of volume, making the country the largest provider of generic medicines in the world, according to government data.

It won’t be easy. The U.S. FDA has banned 42 drug manufacturing plants in India from sending products to the U.S., many of which were cited for deleting quality tests that showed products failed to meet American standards and retesting until they got the desired results. Companies deleted tests for quality measures including detecting impurities that could contaminate the drugs or checking the levels of key active ingredients, according to FDA inspection documents.

Sun Pharmaceutical Industries Ltd., the largest drugmaker in India, bought Ranbaxy in a deal that closed last year, after the U.S. settlement. Sun didn’t respond to a request for comment.

Thakur knows he has a long road ahead. His ultimate goal is a regulatory system in India that looks more like that of the European Union, where the central European Medicines Agency oversees the regulatory framework the 28 member states operate under.

He recognizes this could take years.

“The Indian regulatory system is so broken down, so bad right now,” he said.

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