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Indian pharma is not sub-par, it is ensuring the world doesn’t face a healthcare crisis

Katherine Eban's book 'Bottle of Lies', about the 2004 Ranbaxy scandal, paints whole of Indian pharma as being unreliable, which is dangerous & biased.

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Fortune contributor Katherine Eban has written a new book, called Bottle of Lies: Ranbaxy and the Dark Side of Indian Pharma. The book deals with the story of the 2004 whistleblowing and the subsequent downfall of Ranbaxy.

First and foremost, I think the readers should understand that this book has been written about an event that took place nearly 15 years ago. This was a time when a whistle-blower revealed a lot of misdoings at a Ranbaxy development centre, in its drug manufacturing and development efforts.

I think that issue has been talked about, discussed, debated, and we’ve chewed the cud for a long, long time. I don’t think that in 2019 we need to resurrect it again, because while it did do a lot of damage to Ranbaxy, there was also a lot of unfair collateral damage to other Indian pharmaceutical companies at the time.

I don’t subscribe to most of what has been written in that book, because a) it starts with a very old incident which has been addressed and resolved over time, and b) the company no longer exists.

State of India’s pharma industry

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. India today, in terms of sheer volume, accounts for over a third of generic drugs being sold in the world. And 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.

Today, healthcare costs are spiralling out of control, mainly in the developed world. The Indian pharmaceutical industry is playing a very crucial role in making sure that global healthcare costs are contained and that there is affordable access to life-saving drugs and to important drugs for every patient across the world. If it wasn’t for generics, even high income countries could not afford the healthcare costs that they can today.

Indian pharma development and facilities are not sub-par. In fact, we have far greater automation in the industry than the US. We have state-of-the-art equipment and instrumentation as well, and our logistics and facilities are second to none.

We should also realise that books like Bottle of Lies can be dangerous, as they very selectively pick anecdotes about certain events or incidents, and miss important facts. Such books then paint the whole sector as being unreliable, which I think is extremely dangerous and very biased.

Also read: Indian pharma firm Strides tried to destroy quality records ahead of US FDA inspection

Regulatory bodies

If we look at reliable Indian pharma companies, they have all been inspected by United States Food and Drug Administration (USFDA) and the European Medicines Agency (EMA). These are credible and responsible companies investing hugely in constantly improving their quality management systems.

There are a large number of Indian pharmaceutical companies being inspected, audited, and then cleared by the most stringent regulatory authorities in the world. In fact, India has the second largest number of drug dossiers being approved by the USFDA after the US. The same holds true for European regulators as well.

Now, within India, the challenge is that we have a central regulator who’s doing a great job of coming up with stringent regulations that are on par with the global regulators. But the problem lies at the state level, where regulators are not doing a good job in many states. I would also hasten to add that they are doing a decent job in several others.

State regulators often turn a blind eye to some of the wrongdoings of small pharmaceutical companies in their states, as most of them tend to be small and medium-sized enterprises (SMEs). When government tenders are put out by states, SMEs often tend to be the lowest bidders.

By nature, we tend not to be too harsh towards SMEs as they need a lot of support. So, they get awarded these contracts but then are found lacking in quality. Support for SMEs in pharma should come via building good and reliable regulatory practices, not by looking away from their transgressions. State regulatory authorities really need to beef up their systems and approaches.

These SMEs often tend to be domestic, and do not export products. Of course, even for our own citizens, we need to have better regulatory standards. We do at least have a central regulatory body that is on par with international standards.

More and more stringency

What we see now is not loss of business in high-income countries — the US and Europe continue to very much be dependent on Indian generics.

However, the USFDA inspectors and auditors are becoming more and more stringent with Indian companies because of this kind of reporting and writing, which is essentially making them forensic audits. The Indian companies and the government itself should do a better job of profiling India’s role in global healthcare.

Yes, of course, every industry around the world has black sheep. But they shouldn’t be the only focus in the larger narrative. It is imperative that there is also attention on that part of Indian industry that is doing this yeoman service for the world.

I don’t think it’s fair to write sensationalistic books just because there’s a punching bag easily available. The trouble is that people around the world have certain perceptions, and it’s very easy to start whipping up sentiments around them.

What the author of this book has done is something which I don’t think is good, honest reporting. A lot of it is anecdotal reporting, especially from the whistle-blower, and no one is giving the big picture of what Indian pharma actually is like.

Had the book been more balanced in its coverage and included the true contribution of India to the pharmaceutical industry as well, and shown Ranbaxy in that context, it would have been far more accurate and fair.

As told to Sandhya Ramesh, ThePrint’s senior assistant editor, science.

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.

Also read: The 6 developments that will determine the future of health in India — Kiran Mazumdar Shaw

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  1. Katherine Eban and Kiran Mazumdar Shaw have one fundamental distinction: only one of them has a vested interest in the Indian generics industry. Readers can decide for themselves whom to believe.

  2. I’ve read the entire book and don’t agree with Dr Kiran Mazumdar Shaw’s facile conclusion. Yes the bulk of the book is about Rambaxy and events more than 10 years old but it’s the all pervasive culture of ‘profit’ before ‘patients’ and widespread deep-rooted systemic dishonesty the author brings out. There’s nothing to suggest that has changed. And companies like Dr Reddy’s, Wockhardt, Zydus, GVS don’t exactly come out smelling of roses. It’s cold comfort that China is probably just as bad. We can either dismiss the book as motivated unsubstantiated propaganda or do some serious introspection. Pharma sector leaders like Dr Kiran Mazumdar Shaw need to take a proactive rather than defensive role. Mine, her and her mother’s lives may literally depend on that.

  3. Kiran Mazumdar Shaw’s criticism of Katherine Eban’s book “Bottle of Lies” is totally unwarranted and completely unfair. I’ve read the full book and I agree with Katherine Eban on every point elaborated in the book. Contrary to what Kiran Mazumdar Shaw alleges, nothing in the book is anecdotal ― every fact in the narrative of the book is deeply researched and completely documented (see the 49 pages of “Notes” at the end of the book, with extensive links to documents available in public domain).

    I agree that the protagonist in the book is Ranbaxy, but the theme is rampant data manipulation in Indian pharma industry with several examples including Wockhardt. The fact that nothing seems to have changed since the infamous days of Ranbaxy is evident even today. As recent as yesterday, USFDA found significant violations in Strides Pharma which led to its stock price plummeting 8%.

    To be fair, Katherine Eban has very generously praised Cipla and it’s founder Dr Khwaja Abdul Hamied and his son for carrying the original vision of the generic drugs movement.

    • Indians do not like deep reseach which brings out much from underneath . first reaction deny and lase we are investgating samle ;;; IL 7 FS Dewan housing , ICICI,

  4. There is no doubt of amazing contribution in health care system by developing generic and active materials. Played well

  5. Pharmaceuticals is in fact one industry in which India has a long term competitive advantage. The government should assist it to reach global norms, taking care to avoid what happened to Ranbaxy. As cost of healthcare becomes a universal concern, India’s pharmaceutical industry can look forward to sustained growth.

  6. If all that about generic drug makers wasn’t true why would unannounced checks by US drug Inspectors find so many faults in our companies and they didnt object they asked for time to get it corrected they could have challenged the fault pointed out.
    Our drug Inspectors dont do any surprise checks, if they did perhaps the World would have greater faith in our generic drugs.
    Chins too was found not being honest in their manufacture.
    Recently n eye doctor pointed the difference in prescribed eye drops for his patients and the generic one which caused irritation and redness .Patients can tell the difference, what more proof does one need.

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