Indian Pharma Is Not Sub-Par, It Is Ensuring The World Doesn’t Face A Healthcare Crisis

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 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.

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.

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. – The Print