In June 2013, the U.S. Food and Drug Administration tapped Altaf Lal, an American of Indian origin with sterling public-health credentials, to solve what appeared to be a diplomacy problem. The FDA’s relations with Indian regulators were in tatters, one month after India’s largest drug company, Ranbaxy, pleaded guilty to seven felonies related to falsifying quality data for generic drugs it was selling in the United States. Ranbaxy seemed to stand alone as an overseas drug company that had broken U.S. laws and flouted critical regulations.
Lal, the newly-appointed head of the FDA’s India office, outlined three goals in an agency blogpost: to establish a trusting relationship with Indian regulators; to conduct “prompt and thorough inspections” at the manufacturing plants that made drugs for the U.S. market; and to help Indian “industry and regulators understand that protecting the quality, safety and effectiveness of every product is essential.”
In India, the stakes could not be higher for American consumers. Forty percent of all generics dispensed to Americans are manufactured in India. Many of the manufacturing facilities are aseptic plants, which means they have to operate with perfect sterility, and they provide finished doses—completed capsules, pills and tablets—to American patients. The U.S. and Indian governments needed to work together to ensure product safety: the United States was India’s biggest pharmaceutical customer, and India was one of its biggest suppliers.
But in New Delhi, Lal found not just a diplomacy problem, but a public-health crisis in the making. The FDA was relying on a toothless system of pre-announced inspections that was allowing drug plants to stage inspections. “You guys must be in La La Land,” is how one Indian pharma executive summed up for Lal the FDA’s performance in India to date. In short order, Lal launched a transformative but controversial inspection program that exposed just how badly U.S. regulators were being hoodwinked.