Behind India’s Big Pharma

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Here’s an excerpt from Katherine Eban’s ‘Bottle of Lies’, an incisive insight into the murky world India’s biggest pharmaceutical companies – 

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 Wock-hardt, 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.

Given the high stakes—lives on one side, and profits on the other—fear governed the inspection. Baker feared that he would miss something that would endanger the lives of U.S. patients. Wockhardt officials feared that he would find something that would restrict the company’s access to the U.S. market. They needed every advantage to survive the FDA’s inspection. Here, Wockhardt had several things stacked in its favor. The plant was massive, roughly the size of a small city. Baker and his colleague had just one week to inspect the site. With only five working days, how much could they find?

But Wockhardt had an even bigger advantage. Company executives had known for weeks that Baker was coming to inspect their factory. In the United States, FDA investigators simply showed up unannounced and stayed as long as was needed. But for overseas inspections—due to the complex logistics of getting visas and ensuring access to the plant—the FDA had chosen a different approach: to announce its inspections in advance. As was typical, Wockhardt had “invited” the FDA to inspect and the agency had accepted. Plant officials served as hosts and Baker was their guest—albeit one whose arrival they dreaded.

Given weeks of lead time, the officials worked feverishly to prepare for Baker’s arrival. They polished floors, cleaned equipment, and combed through files to rid them of anomalies. They warned their employees to remain polite but silent, and to let their supervisors answer questions. They had fixed everything in every place where investigators were likely to look, a drill they’d endured fifteen months earlier when a different inspection team had arrived from the FDA.

On that visit, the investigators had found some troubling shortcomings: live bugs in a water storage tank, flooring in disrepair, ineffective cleaning procedures. But the investigators had recommended, not demanded, that the plant make corrections. In the FDA’s coding system, they had given the plant a passing grade, one known as “Voluntary Action Indicated” (VAI). This meant that the Wockhardt operation had survived the inspection with no restriction to its most lucrative franchise—the sale of drugs to the United States.

This time, though company officials had planned for an inspection, they had not planned for Peter Baker. Unlike so many other FDA investigators, he was hard to prepare for—and control. He wouldn’t tolerate an opening slide show or a guided tour, which were typical ways for plant officials to run down the clock. He seemed to be everywhere at once. He studied the employees for signs of evasion as he questioned them repeatedly. Company officials quickly ascertained that his visit posed a serious threat, one that would require drastic action on their part if the plant was to emerge unscathed.

On the second day of his inspection, Baker and his colleague entered a hallway far from the sensitive areas of the facility. It was a place where he could let down his guard. But as he looked down the long, gleaming corridor, he noticed a man at the far end who was walking toward him just a little too quickly. The man, a plant employee, had a furtive demeanor. In one hand, he carried a clear garbage bag full of papers and assorted refuse, making his hurried walk seem even stranger. As the man glanced up, he noticed Baker and momentarily froze. The two men locked eyes.

Abruptly, the man pivoted and returned the way he had come. Baker followed him, quickening his pace. The employee sped up, too, until the two men were engaged in a low-speed chase beneath the fluorescent lights.

“Stop!” yelled Baker’s colleague, the microbiologist. The man broke into an open run. As he bolted, the investigators gave chase until the employee flung open a side door, careened from the hallway, and hurled the bag onto a pile of garbage in a dim storage area beneath a stairwell, then scrambled up a flight of stairs and vanished into the building’s concrete maze.

Baker, close behind, retrieved the bag. Inside, he discovered roughly seventy-five manufacturing records for the company’s insulin products. They had been hastily torn in half, but he was able to piece some together. As he did, his concern grew. They revealed that many of the vials contained black particles, potentially deadly contaminants, and had failed visual inspection.

Under good manufacturing practices, every record created at the plant had to be made available to regulators. But these documents were marked “for internal dept. use only.” Baker suspected that the records were secret for a reason. The testing results were so bad that, had they been disclosed, the plant would have had to launch a costly internal investigation and likely reject every batch it produced.

Over the next three days, Baker demanded that Wockhardt officials open their computers, as was his right, and he began scouring records. One by one, he uncovered the company’s deceptions. As he suspected, the records from the garbage bag had not been logged into the company’s official system. The drugs flagged in the records had been released to patients in India and the Middle East. Baker discovered that the drugs had been manufactured in a secret formulation area that the FDA had never known about or inspected. Once he arrived there, he learned that Wockhardt had used the same defective equipment, in the same secret area, to make medicine for the U.S. market—including the injectable drug adenosine, which treated irregular heartbeat.

The result was a disaster for Wockhardt. Two months after Baker’s inspection, the FDA restricted the import of drugs from the Waluj plant into the United States, a potential $100 million loss in sales for the company. The next day, Wockhardt’s CEO held an emergency conference call with anxious investors to assure them that the company would bring the plant into compliance “in a month or two months maximum.”

At a glance, the plant appeared perfectly run, the equipment shiny and new, its procedures meticulous and compliant. But the torn records Baker had uncovered led him beneath the plant’s impeccable surface and into a labyrinth of lies, where nothing was what it appeared to be. The records were false. Drugs were manufactured in a secret area. Some of them contained visible contaminants that endangered patients. Baker, who had pieced all this together over the course of five punishing days, was left to wonder: if so much inside this plant was fake, what, if anything, was real?

‘Bottle of Lies’ will be available to read for free on 7th October, 2021 as part of #ReadersChoice on the Juggernaut App!

 

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