Securing the Supply Chain: Combating the Evolving Risks in Pharmaceutical Sourcing and Manufacturing

363467Unprecedented regulatory actions such as the invocation of the Application Integrity Policy, a highly restrictive and cumbersome Consent Decree, and successive import alerts have emphasized the risks to the pharmaceutical supply chain, especially when sourcing API, intermediates, excipients from countries like India and China. Although the industry is beginning proactive measures in developed economies avoiding the supply of substandard and adulterated drugs, many pharmaceutical companies have not addressed these risks adequately. Using the prosecution of Ranbaxy Laboratories in the US as an example, Thakur (formerly Ranbaxy’s Director and Global Head, Research Information and Portfolio Management, who reported the company’s failings to the US FDA) focuses on the need for an independent, third-party monitoring of the supply chain to ensure consistency in the quality of medicines supplied to all countries.

 Dinesh S. Thakur is an expert and accomplished entrepreneur in pharmaceuticals, biomedical product development, drug regulation, and information technology. During his career, he held senior positions at Bristol-Myers Squibb Company, Ranbaxy Laboratories, and Infosys Technologies. Most recently, he co-founded and was the Chief Executive Officer of Sciformix Corporation, a scientific processing outsourcing organization that delivers services in the areas of drug safety, biometrics, medical and regulatory writing, and clinical operations. From 2003 to 2005, Thakur was the Director and Global Head, Research Information and Portfolio Management at Ranbaxy Laboratories, India’s largest generic drug manufacturer. He was responsible for managing research and development information for generic drug development, manufacturing, and commercial operations. In addition, he implemented automated systems to capture research and development data for global regulatory submissions, compliance, and manufacturing. While at Ranbaxy, Thakur discovered that the company was falsifying drug data and violating current good manufacturing practices and good laboratory practices. He resigned in 2005 after reporting the fraud to company management, and worked with 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. The groundbreaking settlement is the largest of its kind against a generic drug manufacturer. Thakur received a Bachelor’s degree in technology from Osmania University, an MS in chemical engineering from University of New Hampshire, and graduate training from Syracuse University.

Since Ranbaxy, how have regulators and regulations evolved to recognize manufacturers attempting to manipulate the system? What are pharmaceutical companies experiencing now that is a direct result of Ranbaxy’s falsifications?

Clearly, there is more awareness at the US FDA and the UK MHRA that data integrity problems are a lot more pervasive than originally thought. There is widespread acceptance that economically motivated adulteration is real and poses a significant threat to the quality of our drug supply. Therefore, inspectors are now conducting “forensic” audits explicitly looking for evidence of fraud, like discarded raw data, evidence of testing into compliance, false evidence of stability testing, etc. The regulations themselves remain largely unchanged, just that regulators are now allocating additional resources to monitor such activities. The US FDA has provided a focus to this effort through the newly established Office of Pharmaceutical Quality. The regulatory actions at Ranbaxy and Wockhardt have had material impact. In addition to loss of reputation, these actions have had a significant financial impact. As far as global pharmaceutical companies are concerned, I haven’t seen a major change in their approach to managing their upstream supply chain from foreign locations in public. I think companies recognize the inherent risks, but have yet to undertake a systematic ongoing evaluation of their sourcing processes to identify risks and adopt appropriate mitigation strategies yet.

Read more of the interview in the July/August Issue of Pharmaceutical Engineering Magazine. Or mark your calendar to hear his presentation during ISPE’s Annual Meeting, Sunday, 12 October: 15.30 – 17.00 Milano Ballroom (Promenade Level).Learn more about the 2014 ISPE Annual Meeting here.