New Delhi: A new book is warning India’s biggest pharmaceutical export market — the US — against consuming the country’s generic drugs, arguing that they are of “flea-market quality”.
The Bottle of Lies by investigative journalist Katherine Eban has accused Indian pharmaceutical companies of committing major lapses while manufacturing the medicines such as fudging data on quality control and toxic impurities, overlooking bird infestations at manufacturing plants
Launched on 14 May, the book is set to deal another major blow, within a week, to the reputation of Indian drugmakers, already facing scrutiny in the US for engaging in illegal practices. Last Friday, 10 May, seven Indian companies were among the 20 pharmaceutical firms that were named in a lawsuit filed by 44 US states. The companies have been accused of indulging in “illegal conspiracies to stifle competition for generic drugs and even illegal profiteering in over 100 different drugs”.
Bottle of Lies draws on interviews with over 240 people but focuses on the case of Ranbaxy and Dinesh Thakur, a former employee of Indian generic giant who is now a whistle-blower against it. The book has been described as “an invaluable expose, a reportorial tour de force and a well-turned epic” by The New York Times.
“For many years, few people wanted to take Indian medicine, let alone praise the companies making it,” Eban has written. “To the brand-name pharmaceutical companies that had spent decades and millions developing drugs, the Indian companies that copied their products were no better than thieves.”
Indian drugmakers, however, told ThePrint that the book indulges in “India-bashing” and alleged that it has cited cases for which the pharmaceutical firms had already taken “corrective measures”.
“When an industry is developing, it has certain failures and it commits certain mistakes. But this doesn’t mean corrections have not been carried out,” said Ashok Madan, executive director, Indian Drug Manufacturers’ Association, a lobby representing over 1,000 pharmaceutical companies in India.
“In fact, the book only considered the past incidents for which companies have already faced remedial action. It did not take into accounts that since several decades people have recovered after consuming our pills. The writer has done just bashing India, despite agreeing that the majority of the US consumes our medicines.”
Generic drugs and Ranbaxy
The book highlights the US generic boom, pointing out that 90 per cent of the American drug supply was made of generics, which were an essential counterweight to the rising prices of branded drugs.
India is among the biggest players in this market. According to data with the Ministry of Commerce and Industry, in the 2018-19 fiscal, India exported $5,820 million worth pharma products to the US against the $5,118 million in the 2017-18 fiscal — a jump of around 14 per cent.
The book acknowledges this fact. “Roughly 40 per cent of generic drugs are manufactured in India. A full 80 per cent of active ingredients in all our drugs, whether brand name or generic, are made in India and China,” Eban has written. “As one drug-ingredient importer told me, ‘Without products from overseas, not a single drug could be made’.”
The book, however, focuses on the dark side of the trade, particularly focusing on Ranbaxy — once the poster boy of India’s pharmaceutical growth story and the first overseas manufacturer to sell generic drugs in the US.
In 2013, Ranbaxy pled guilty in the US and paid $500 million in fines for selling adulterated drugs and lying to the American drug regulator, the Food and Drug Administration (FDA).
Bottle of Lies delves into Ranbaxy’s troubles with whistle-blower Thakur, who contacted the FDA in 2005 about the company’s malpractices.
The journalist has also quoted American drug inspectors, including one Peter Baker, who visited Ranbaxy’s manufacturing unit at Toansa in Punjab in 2014. “By showing up unannounced, the men saw things they never would have otherwise as they pushed through the facility: vials stuck in the back of the drawer, a sample preparation room swarmed by flies because windows were stuck open with piles of trash directly outside,” the book reads.
The book notes that Baker, in his final report on Ranbaxy, had written that there were “flies TNTC (too numerous to count)”. The inspection resulted in a warning letter and an embargo on the plant’s drugs.
According to Eban, Baker had inspected the premises of another popular Indian drugmaker — the Mumbai-based Wockhardt — in 2013 and had encountered an equally “devastating” situation.
“They (Baker’s findings) painted a picture of an elaborate fraud, extreme hazard, and filth,” the book reads. “One official dumped vials into a drainage sink after Baker enquired about their contents. In the bathroom, about 20 feet away from the gowning area for sterile formulation lab, the urinals lacked drainage piping.”
At another inspection site in Hyderabad, Baker allegedly saw vials of chemotherapy drugs that had improperly sealed caps and therefore, weren’t sterile. “What the heck did you do with this,” he asked to which the official replied, “We sent it to Africa”.
Describing the controversy over the falsification of data by GVK Biosciences — a contract research organisation hired by drug makers to test their medicines on patients — in 2014, which had led to the ban on 700 Indian-made drugs in the European Union, the book states, “Prime Minister Modi even personally lobbied German chancellor Angela Merkel to lift the ban.”
Blaming the US drug regulator
Eban has also blamed the FDA for not plugging the safety gaps.
She has pointed out that the FDA only conducted unannounced overseas inspections between 2014 and 2016 and then went back to notifying Indian plants of routine inspections in advance.
She has also alleged that between 2012 and 2018, the FDA downgraded 112 inspections in India to make the final classifications less severe. For company after company — Mylan, Cipla, Aurobindo, Dr Reddy’s, Sun Pharma, Glenmark — findings of ‘official action indicated’ became ‘voluntary action indicated’, Eban’s book states.
“People have the right to know what they are taking and to choose what they didn’t want to take,” the book adds. “But American patients had no idea of the subterfuge that went into the manufacturing of their low-cost medicine and the FDA had no plans to tell them.”