“They often make their worst drugs — with the lowest-quality ingredients and the most manufacturing shortcuts — for the least regulated markets, including India,” writes investigative journalist Katherine Eban in her book Bottle of Lies: The Inside Story of the Generic Boom (also subtitled as Ranbaxy and the Dark Side of Indian Pharma), an exposé of Indian pharma.
The book, which has created quite a storm in the Indian pharmaceutical industry ever since its launch in the US in May, hit the stands in India in recent days and likely to reignite the controversy. This much-talked about book exposes the dark underbelly of Indian generics industry by highlighting the story of whistleblower Dinesh Thakur, who tried to stop Ranbaxy Laboratories from covering up their careless drug production.
A young executive at Ranbaxy, Thakur resigned from the company after discovering that the company is sending faulty drugs to Africa, where they are likely to go undetected. He later spills everything he knows to the US Food and Drug Administration (FDA). The riveting and gripping story keeps the reader on the edge to find that whistleblowers in India are not only under threat by a corrupt system but also can’t expect any protection from the regulators.
“In humankind’s love of profit, everyone else is often ignored.”
Speaking to Health Issues India, Thakur told us, “the source of the entire mess is our outdated colonial-era Drugs and Cosmetics Act; it has not stayed current with evolution in science and the manufacture of drugs. This coupled with collusion between regulators and the industry as amply documented in the various reports of the Parliamentary Standing Committees create an environment where industry acts with a sense of impunity and puts public health at risk with little to no consequence.”
After resigning from Ranbaxy, Thakur said that “had very little in the way of interaction directly with the Indian regulator.” Elaborating, he noted “my efforts to assist the Ministry of Health and Family Welfare in dealing with the issue of fraud and pervasive wrongdoing in the Indian pharma industry was rebuffed by the then-Minister, Dr Harsh Vardhan.” (Dr Vardhan was reappointed to the Union Health Ministry earlier this year). On another occasion, he said, “I sought to meet with then DCGI, Mr G N Singh because we were to be on the same panel together at a meeting in Kolkata, but he never showed up.”
Eban reveals an industry where corruption is rampant, companies falsify data, and executives dodge every law to minimize cost and maximize profit. Meanwhile, patients bare the brunt of their greed by unknowingly consuming medicines with unpredictable and dangerous side-effect.
In humankind’s love of profit, everyone else is often ignored. Eban advises consumers to research who manufactures their generics and look up any problems that regulators have found out about them.
In India, generics drug form the seventy percent of the market and their influence is only set to increase with the coverage of Ayushman Bharat. According to EY, India is the largest provider of generics, whereas the country imports forty percent of its generics from the US market. According to The New York Times, Eban lays bare how “Gandhi’s well-intentioned local action to bring affordable drugs to India through the concept of generics has become hellish global fraud.”
“This book comes as a wake-up call for Indian policymakers and seeks to frame stringent regulations for the sector and cross verify the claims made by the book. It is the poor Indian population that relies on these generic medicines to live a healthy life, unaware that the pill they are popping to cure or manage their disease may lead to other severe illnesses due to its side-effects. Profiteering at their expense cannot be tolerated.”
However, Indian pharma lobby groups have dismissed the claims as ‘fictitious’ and described the situation in her book is far in the past. Speaking to The Indian Express, Sudarshan Jain of the Indian Pharmaceutical Alliance (IPA), says IPA members are committed to “global standards of quality” and that the information in this book is “dated”. Ranjt Barshikar, a quality expert consultant to the United Nations, told the newspaper that data integrity and documentation was a larger issue a decade ago.
Thakur disagrees, “the warning letters it [USFDA] issued to Indian manufacturers last year (2018) to see the extent and prevalence of the behavior we find so objectionable now that it is described and substantiated in the book and ask ourselves how that squares with the claims the Indian pharma lobby make.”
Thakur further elaborates the presence of malpractices in the system, “the latest example is that of Apotex, a Canadian Generic Manufacturer withdrawing 31 approvals… yesterday from the US FDA because it couldn’t substantiate the data it used to secure these approvals which were filed largely from its facility in Bangalore, India. Yesterday is not dated, is it?”
Eban also denies the Indian pharma lobby’s defence, saying “between that and ongoing tips, I have received from whistleblowers at Indian companies, that tells me the practices continue today,” she says. Investigators are still turning up examples of “willful data manipulation.”
“It is critical that governments move beyond a regulatory honour system, relying on pre-announced inspections and company-generated data,” Eban told The Economic Times in an interview. “Governments need to conduct unannounced inspections and randomly test the quality of drugs in an ongoing surveillance system.
“The glut of substandard generics in developing markets has a profound public health impact, not just on patients who take them, but on everyone. Substandard drugs do not contain enough active ingredients to effectively cure sick patients, they can contain enough to kill off the weakest microbes while leaving the strongest intact. These surviving microbes go on to reproduce, fuelling a growing epidemic of drug resistance worldwide.”
This book comes as a wake-up call for Indian policymakers and seeks to frame stringent regulations for the sector and cross verify the claims made by the book. t is the poor Indian population that relies on these generic medicines to live a healthy life, unaware that the pill they are popping to cure or manage their disease may lead to other severe illnesses due to its side-effects. Profiteering at their expense cannot be tolerated