New Delhi: The central government is looking to take action against American investigative journalist Katherine Eban, who raised questions about the Indian pharmaceutical industry in her May 2019 book Bottle of Lies.
Among other things, she labelled made-in-India drugs as being of “flea-market quality” and cast doubt on the country’s image as “pharmacy of the world”, a tag it gained by producing cheaper generic versions of expensive branded drugs for diseases such as cancer.
The idea of taking action against Eban was mentioned in a four-page note sent by the Central Drugs Standard Control Organisation (CDSCO), the country’s apex drug regulator, to the Ministry of Health and Family Welfare.
“A brief perusal of the book reveals that there is no co-relating data available in the representing story and statements have been made based on the assumptions,” the CDSCO says in the undated note, adding that the author’s allegations were “fiction-filled stories”.
Presenting several details about the status of the industry, the note, accessed by ThePrint, adds, “In view of the above, the ministry may consider taking appropriate action to counter the allegations made in the book.”
The note came after the ministry last year asked the regulator to conduct an inquiry into and verify claims made by Eban amid apprehensions about the book’s possible impact on the Indian pharma industry.
ThePrint approached Eban for comment but she refused to offer one, saying, “Without seeing the (original) note, I really wouldn’t have any comment.”
She will be in India for a discussion on her book, which is now a New York Times bestseller.
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‘Such allegations made from time to time’
In her book, Eban accused Indian pharmaceutical companies of major lapses, such as “toxic impurities” in drugs, fudging data on quality control, and overlooking bird infestations at manufacturing plants.
The CDSCO, however, has made light of the accusations, saying such allegations have been made from “time to time attempting to malign Indian pharmaceutical industries due to their strong presence globally”.
“…The book is completely based mainly on interviews, which included individuals, organisations, media reports etc,” it says.
India, the note adds, “is the largest supplier of generic drugs across the globe and makes it available to the globe at affordable price”.
It then quotes government data to emphasise the strength and size of the industry.
According to the note, India accounts for 20 per cent of global exports in generics. Its pharmaceutical exports stood at $17.27 billion in FY18 and are expected to reach $20 billion by this year, it adds.
“Indian pharmaceutical companies received record 300 generic drugs approval in the USA during 2017 where the generic market is expected to reach $88 billion by 2021,” it says.
The note then talks about pressure from western drug companies who find their market share shrinking amid the growth of the Indian industry.
“…The global pharmaceutical industry put its own pressure on India as these generics have been a game-changer in terms of being able to provide medical care in developed as well as in developing countries,” it says.
“Strong development, growth and presence of Indian pharmaceutical industry have actually threatened the many players globally because of competitiveness,” the note adds.
Eban’s claims in the book are not a first. She has earlier made similar allegations in articles written for foreign magazines, a fact pointed out by the CDSCO.
“…An article published in Fortune magazine in 2013 alleged how [an] Indian generic company had deceived regulators around the world by submitting fraudulent data that made its drugs appear bioequivalent to brand-name drugs,” it says.
“Another allegation was made in an article published in Self magazine in 2009 on the quality of the generic drugs,” the note adds.
Defending the regulatory framework
The note then goes on to defend the Indian regulatory framework, saying quality has always been the first and foremost priority at every level.
“The MoHFW, CDSCO and the state drugs regulatory authorities have been engaged continuously to ensure the quality of drugs manufactured in the country,” it says.
The note cites a National Drug Survey conducted by the National Institute of Biologicals to assess the extent of ‘not-of-standard quality (NSQ) or spurious drugs in the country in 2014-16.
“Out of a total 47,012 drug samples drawn from both government and private sources, the estimated percentage of NSQ and spurious drugs was found to be 3.16 per cent and 0.0245 per cent, respectively,” it says.
It isn’t just the government that has refuted the allegations, even industrialists such as Biocon chairperson and managing director Kiran Mazumadr Shaw defended India’s health sector.
Writing for ThePrint last year, she said she doesn’t subscribe to most of what is written in the book.
“It’s very important for people to know that global healthcare has benefited hugely from the Indian pharmaceutical industry, and from generic drugs that the Indian pharmaceutical industry produces for the world…. In many parts of the world, generic drugs account for almost 40 to 50 per cent of different markets. Without this, the healthcare burden on every part of the world — especially in the developed world — would be huge.”
Kiran Mazumdar Shaw is chairperson and managing director of Biocon. She is among the distinguished founder-investors of ThePrint. Please click here for details on investors.
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The issue is about quality control, purity, and accuracy of preparations, as well as how they are packaged, under what conditions they are transported and stored. There is over-prescription of drugs, even for children. Its not *just* a problem with manufacturers of therapeutic preparations, but the whole ecosystem that needs an emergency revamp, a change from the foundations.
It called free speech, If printed in news papers, go there and if journal, write to editor. Can you litigate? I doubt.
She is an international , Urban Naxal .
The US pharmaceutical industry has always had a problem with the Indian generic market. So it’s no surprise that this kind of a book would be published, which fudges data and reality, and paints an alarmist and dangerous and grim view of Indian Pharmaceuticals. I think more than the government criticizing the book, pharmaceutical companies like Sun Pharma, Cipla, etc. should come forth and deliver strong criticism of this book and its various rumour-mongering inaccuracies.
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