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Although in May 2013 Ranbaxy pleaded guilty to seven felonies related to its quality-control problems, the Indian drug company continues to export billions of dollars of drugs worldwide. So how reliable are India's drugs, and what are the global implications? At an AEI event on Monday, Dinesh Thakur, a former Ranbaxy executive and the whistleblower in the Ranbaxy case, joined experts from AEI, the Cleveland Clinic, and the World Bank to discuss his experiences and the wider problems of Indian drug quality.
AEI's Roger Bate began the discussion by emphasizing that drug safety must be addressed in both India and the US, as most drugs on the US market come from India. Thakur brought up a 2007 inspection report by the World Health Organization, which spotted potential falsified drug issues in India but did not garner public attention. He pointed out that while the drug supply chain is globalizing, manufacturers, policymakers, and regulators have different goals, making regulations even more complicated.
Andreas Seiter of the World Bank stressed that drug quality regulation is difficult not only in India and China but also in Europe, Africa, and Latin America. Dr. Harry Lever of the Cleveland Clinic joined the conversation via video and shared the cases he encountered that resulted from falsified generic drugs. The panel agreed that policymakers and regulatory institutions should be constantly reminded of the dire consequences of poor regulation and should combat it through preemptive measures.
In 2005, Dinesh Thakur, a former Ranbaxy executive, reported Ranbaxy’s significant quality-control problems to the US Food and Drug Administration. In May 2013, the Indian drug company pleaded guilty in a US court to seven felonies, culminating in a $500 million settlement against Ranbaxy.
But Ranbaxy has not been sanctioned in India, is still considered one of the better Indian drug companies, and exports billions of dollars of drugs to dozens of countries around the world, including to the US. So how reliable are India’s drugs?
At this event, Thakur will discuss his experiences and the wider problems of Indian drug quality. Pharmaceutical and medical experts will then discuss Thakur’s remarks and the safety of US and international drugs.
Copies of Roger Bate’s 2012 book, “Phake: The Deadly World of Falsified and Substandard Medicines,” will be sold at the event.
If you are unable to attend, we welcome you to watch the event live on this page. Join the conversation on Twitter with #DeadlyDrugs. Full video will be posted within 24 hours.
Harry Lever, Cleveland Clinic
Andreas Seiter, World Bank
Dinesh Thakur, Former Ranbaxy Executive
Roger Bate, AEI
For more information, please contact Hao Fu at [email protected], 202.419.5214.
For media inquiries, please contact [email protected], 202.862.5829.
Roger Bate is a visiting scholar at AEI and an economist who researches international health policy, with a particular focus on tropical disease and substandard and counterfeit medicines. He is a fellow at the Institute of Economic Affairs and is on the board of directors of Africa Fighting Malaria. He writes regularly for AEI's Health Policy Outlook.
Harry Lever, MD, is the medical director of the Hypertrophic Cardiomyopathy Clinic within the Cleveland Clinic’s Arnold Miller Family Heart and Vascular Institute. Dr. Lever is one the world’s leading experts in diagnosis and management of hypertrophic cardiomyopathy and has received awards for his work in this area, in particular from the Hypertrophic Cardiomyopathy Association.
Andreas Seiter is a senior health specialist at the World Bank’s Health, Nutrition, and Population Anchor. Seiter worked for 18 years in the pharmaceutical industry before joining the World Bank in 2004. He is responsible for the World Bank’s analytical and advisory work in all areas of pharmaceutical policy such as regulation, governance, quality assurance, financing, purchasing, supply chain, and rational use. He has worked with World Bank teams, policymakers, and experts in several Bank client countries in Africa, Eastern Europe, Latin America, the Middle East, and South Asia.
Dinesh Thakur is an entrepreneur and an accomplished leader in biomedical product development, drug regulation, and information technology. During 2003 and 2005, Thakur was the director and global head of research information and portfolio management at Ranbaxy Laboratories, India’s largest generic drug manufacturer. While at Ranbaxy, he discovered that the company was falsifying drug data and violating good manufacturing and laboratory practices. He resigned in 2005 after reporting the fraud to company management, and worked with US authorities for eight years to unravel the complicated trail of falsified records and dangerous manufacturing practices. In May 2013, Ranbaxy pleaded guilty to multiple criminal felonies and agreed to pay $500 million to resolve criminal and civil allegations of falsified drug data and systemic manufacturing violations resulting in substandard and unapproved drugs.