Hardbound

The bitter truth

In Bottle of Lies: Ranbaxy and The Dark Side of Indian Pharma, author Katherine Eban investigates the fall of Ranbaxy — a doom of its own making

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Published 2 years ago on Sep 27, 2019 3 minutes Read

Peter Baker, a drug investigator for the U.S. Food and Drug Administration, traveled two hundred miles east of Mumbai, along a highway choked by truck traffic and down a road with meandering cows, to get to his assignment. Behind a metal fence lay a massive biotech park, run by the Indian generic drug company Wockhardt Ltd. Amid the dozens of buildings, Baker’s job was to inspect a particular area of the plant—Plot H-14/2—to ensure that it could safely make a sterile injectable drug used by American cancer patients.

Baker, thirty-three, had arrived lightly provisioned. He had just a few items in his backpack: a camera, a gel-ink pen, a green U.S. government-issued notebook, and his FDA identification. He had a graduate degree in analytical chemistry and a command of the Code of Federal Regulations, Title 21, the rules that governed drug manufacturing. But more importantly, he had his instincts: a strong sense of what to check and where to look, after completing eighty-one inspections over four and a half years at the FDA.

At 9:00 a.m., the sun already burning, Baker and his colleague, an FDA microbiologist, showed their identification to guards at the gate and were ushered into the plant, where the vice president of manufacturing and other company officials waited anxiously to greet them. In a world of drab auditors toiling with checklists, Baker stood out. He was handsome and energetic. He wore his brownish-blond hair in a buzz cut. On one bicep, he sported the oversized tattooed initials of his motorcycle group. As the officials began their opening presentation, he interrupted with a staccato burst of questions. Was there any other manufacturing area on-site that made sterile drugs for the U.S. market, aside from Plot H-14/2? he asked repeatedly. No, the officials assured him.

Baker’s job—part science and part detective work—had been transformed by the forces of globalization. From 2001 to 2008, the number of drug products imported into the United States had doubled. By 2005, the FDA had more drug plants to inspect abroad than it did within U.S. borders . Baker had been dispatched to Wockhardt, in an industrial area of Aurangabad, because of a global deal that had evolved over more than a decade. Drug makers in India and other countries gained entry to the U.S. pharmaceutical market, the world’s largest and most profitable. In return, the American public got access to affordable versions of lifesaving drugs. But this boon came with a serious caveat: foreign drug manufacturers had to comply with the intensive U.S. regulations known as “current good manufacturing practices” (cGMP) and submit to regular inspections. If everything went according to plan, the result was a win-win for foreign drug makers and American consumers alike.

Though few Americans knew Wockhardt by name, many took its medicine. The company manufactured about 110 different generic drug products for the American market, including a beta blocker— metoprolol succinate—to treat hypertension, which reached about a quarter of U.S. patients taking a generic version of the drug. Because the Aurangabad plant manufactured sterile injectable medicine, the regulations it had to follow were particularly strict.

Every detail mattered. Every digit of data had to be preserved in its original form. As one moved closer to the plant’s sterile core, where vials of medicine sat exposed, the rules became even more restrictive. Employees there had to move slowly and deliberately, so as not to disturb the unidirectional air flow. Even to take notes, FDA investigators had to use sterile, lint-free paper. There was a good reason for these rules. One small slip—a failure to filter air properly, a misreading of bacterial samples, the exposed wrist of a technician—could result in a contaminated product that would kill instead of cure.

This is an extract from Katherine Eban's Bottle of Lies published by Juggernaut.