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There was little effort to conceal this method of doing business. It was common knowledge, from senior managers and heads of research and development to the people responsible for formulation and the clinical people. Essentially, Ranbaxy’s manufacturing standards boiled down to whatever the company could get away with. As Thakur knew from his years of training, a well-made drug is not one that passes its final test. Its quality must be assessed at each step of production and lies in all the data that accompanies it. Each of those test results, recorded along the way, helps to create an essential roadmap of quality. But because Ranbaxy was fixated on results, regulations and requirements were viewed with indifference. Good manufacturing practices were stop signs and inconvenient detours. So Ranbaxy was driving any way it chose to arrive at favorable results, then moving around road signs, rearranging traffic lights, and adjusting mileage after the fact. As the company’s head of analytical research would later tell an auditor: “It is not in Indian culture to record the data while we conduct our experiments.
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