Pharma Sector’s Survival Factor

Dinesh Thakur, known for turning whistleblower against the violations of Good Manufacturing Practices at Ranbaxy Laboratories, the company whose research information & portfolio management he formerly headed, rues that the malaise is far more widespread in the Indian pharma sector. Also that, despite the fact that we have been caught napping by the current Covid-19 pandemic, no real effort has gone into systemic course correction or meaningful investment into health infrastructure….

“The response from the Government of India has been very patchy. They did react early and imposed a lockdown, but other than that specific action, very little of what they have done subsequently inspires any confidence in their ability to govern”

Dinesh Thakur was earlier Director & Global Head, Research Information & Portfolio Management at Ranbaxy Laboratories, India’s largest generic drug manufacturer. He was responsible for managing research and development information for drug development, manufacturing, and commercial operations. He also implemented automated systems to capture research and development data for global regulatory submissions, compliance, and manufacturing.

He is internationally acclaimed as a Ranbaxy whistleblower for his tenacious investigations, bringing out into the open, the compromises in quality control and patient safety in the manufacture of generic medicines by the company he worked in. A book titled ‘Bottle of Lies’ by US-based journalist, Katherine Eban, based on his investigation and findings, was a New York Times bestseller in 2019.

During his career, he also held senior positions at Bristol-Myers Squibb Company and Infosys Technologies. Most recently, he co-founded and was CEO (2007-12) of Sciformix Corporation. He is an expert and accomplished entrepreneur in pharmaceuticals, biomedical product development, drug regulation, and information technology.

Presently, he is a public health activist focussed on improving the quality of affordable medicine across the globe. His current focus is to improve health policy in the United States and in India.

Corporate Citizen interviewed him to get an insight into the COVID-19 impact on India’s Pharmaceutical Industry, on various dimensions.

Corporate Citizen: What is your overview of the present pandemic, COVID-19 which has affected practically every country-in terms of its intensity, and did you see it coming?

Dinesh Thakur: People who work in public health have been talking about a potential pandemic for years now. Bill Gates, who runs the Bill & Melinda Gates Foundation spoke of this very issue several years ago in a TEDMED talk. Therefore, there was awareness about a respiratory virus spreading globally in the past, but sadly, not many countries took proactive action to get prepared to address such an outbreak until it was here.

CC: With reference to India, what do you think of the COVID-19 spread and its management by the government?

The response from the Government of India has been very patchy. They did react early and imposed a lockdown, but other than that specific action, very little of what they have done subsequently inspires any confidence in their ability to govern. The humanitarian tragedy that has been triggered as a consequence of ill-conceived actions was completely man-made and wholly preventable.

"Before this pandemic, China was aggressively building its capabilities to take business away from India. We already source a large percentage of our raw materials from China. They were beginning to move up the value chain by developing skills for formulation, which is our key strength. The fallout from this pandemic is changing the landscape. … How this all works out is too early to tell now”

CC: What was the state of the Pharma industry in India before the coronavirus epidemic?

The Indian pharma industry, which largely makes generic copies of off-patent medicines was still dealing with the fallout of the issues uncovered in the case against Ranbaxy. If you look at the US FDA regulatory action, many of the large companies in India have been cited for gross violations of manufacturing standards over the last two years.

CC: Do you think the anti-malarial drug hydroxychloroquine and its sudden demand by the USA and several other countries and other anti-viral tablets made by India to counter the pandemic has boosted the Pharma economy in India during this COVID-19 crisis?

I don’t think so. There was some acute demand for Hydroxychloroquine initially. But once clinical data began to emerge that this drug is not therapeutically effective against COVID-19, it all fizzled out. It is true that some companies like INTAS and Zydus may have had a short-term opportunity to capitalise on this demand, but it is not applicable across the industry. There have been a series of approvals for other medicines needed to treat this disease, including Azithromycin and Albuterol for Indian generic drug companies, and I am sure this will be a good financial break for those companies that have a valid Abbreviated New Drug Application (ANDA) for these products.

CC: What was the state of the generic medicine industry in India, before coronavirus and now?

The Indian generic drug industry continues to be plagued with issues with compliance and quality of products. Not much has changed over the last five years.

CC: Do you think China’s pharma industry would overtake India’s, particularly because India depends on China for much of the raw material?

It is too early to tell. Before this pandemic, China was aggressively building its capabilities to take business away from India. We already source a large percentage of our raw materials from China. They were beginning to move up the value chain by developing skills for the formulation, which is our key strength. The fallout from this pandemic is changing the landscape. There is an active effort underway in the US Congress to restrict the import of medicines which are either made in China or have ingredients made in China. How this all works out is too early to tell now.

CC: You have been a whistleblower of international acclaim through your bold investigations on compromises in quality control and health safety in Ranbaxy’s manufacture of generic medicines. Do you think it has led to better standards in India in this sector?

Sadly, it has not. Not much has changed in India, despite the fact that the problems which I uncovered in Ranbaxy are not specific to that one company. Unlike the US, where systemic changes were made to drug regulations after the Ranbaxy episode, precious little has been done in India.

CC: Would you say that the pharma industry would be one of the few sectors that would positively benefit from the COVID-19 impact?

Anytime there is a pandemic, the industry that makes drugs, devices, diagnostics, vaccines and so on, always benefits. The question is whether our industry in India will benefit. We have invested very little in developing skills to discover new drugs/therapies in the past. We can try and repurpose existing therapies to see if they are effective in treating this disease, but the payback for that is not the same as if we discovered a new chemical or a biological entity to treat this disease. So yes, the industry will benefit; to what extent, I don’t know.

CC: What do you think of the state of Public Healthcare Management in developed countries including the USA? And countries like India?

Delivery of healthcare is largely privatised in the US. Therefore, when the pandemic broke, the US Congress had to pass a regulation paying for tests and making them accessible for everyone in the country free of cost. Likewise, they provided funding to hospitals to treat patients who needed care after developing an infection. Having said that, the US has a very strong surveillance system. The Centers for Drug Control and Prevention provides a strong policy basis for public health in the US. Therefore the government can take quick action based on real evidence and surveillance data and respond to the pandemic in a timely manner.

In India, we haven’t made any significant investment in public health. Individual states have made some progress, Kerala being a really good example. The fact that Kerala has been able to control this pandemic in such an effective manner is a testament to its public health infrastructure. But this is not true of all the other states in the Union.

There is a lot to be desired when it comes to the robustness of public health systems in the country and unfortunately, it is reflected in the way our response has been to this pandemic.

CC: Is there a need now for top government priority for expenditure in healthcare management? If so, how?

Yes, there is. In times like these, where there is such an immediate and visible need to react to the outbreak, throwing money at this problem does not address systemic issues within our public health infrastructure. We will need to take a holistic look at the problem once this pandemic passes and frame policies based on data. Let me offer a simple example. In the last two months, we have seen several advertisements from state and local governments to hire people trained in epidemiology. If you look closely at the renumeration they offer for these posts, it is pathetic. It speaks of the value that we attribute to public health and people who are trained in this area. This is a knee-jerk reaction to the misery and fear we see all around us. Likewise, we do not have a trusted source of national surveillance data when it comes to disease outbreak. The way this lack of good data manifests is where ICMR revises their recommendations on who needs a test and when so often. They are reacting to segmented and patchy data because we don’t have a consolidated view of what the pandemic looks like at the village and panchayat level. These are systemic issues we have. Just throwing money at them during this pandemic will not solve years of neglect by successive administrations.

CC: What do you think of our nurses, doctors and other paramedical professionals who generally were not provided with enough safety kits although they are frontline COVID warriors?

Clearly not an ideal situation. There have been enough news reports that frontline healthcare workers are not provided with enough protection. In fact, this has been the biggest source of risk for community transmission. The way that the government failed to react with a sense of urgency to protect frontline healthcare workers is a reflection of the poor governance we are straddled with. Even after two months, there are still news reports that certain hospitals and healthcare facilities lack proper PPE for their healthcare workers. This is simply not acceptable in any civilised society.

CC: At the individual level, what is your advice to citizens in terms of prevention and care to counter this pandemic?

There is very little a citizen can do, other than to follow the guidelines that the Ministry of Health and the ICMR have put out. People panic because they don’t understand that this is an infectious disease like any other and will be controlled if we just follow basic hygiene. A vast majority of people will recover with few or no symptoms. A small percentage of people will develop presentable symptoms and will need medical care. Our focus, until such time that we have a vaccine or a therapeutic drug, surveillance and monitoring by healthcare workers using techniques like contact-tracing should be to used to stem the spread of the virus. The guidelines published by the Ministry are helpful if followed. Having said that, we have some real challenges on the ground in following these guidelines. Our sanitation in cities and towns leaves much to be desired. Man-made tragedies like the humanitarian distress that has been caused by poorly executed policies exacerbate the situation. At the end of the day, we have to remember that we are all in this together and not forget the basic aspects of humanity.

CC: Is the pandemic here to stay?

No, the pandemic will be controlled, but the virus is here to stay. This virus is like many others which cause common cold and influenza. It has now crossed the threshold of community transmission. At some point in the future, we will develop herd-immunity to it.

"We do not have a trusted source of national surveillance data when it comes to disease outbreak. The way this lack of good data manifests is where ICMR revises their recommendations on who needs a test and when, so often. They are reacting to segmented and patchy data because we don’t have a consolidated view of what the pandemic looks like at the village and panchayat level”

CC: The book ‘Bottle of Lies’ is an eye-opener to the world of the shocking laxity of an array of factors required to manufacture top-quality generic medicines. Could you summarise your observations and investigations?

Bottle of Lies was written by Katherine Eban based on my investigation into what happened at Ranbaxy when I was employed there. It shows how our regulations and regulators in India fail the people of the country over and over again in making sure that good quality, affordable medicines are made available to patients. It follows my story of an eight-year battle with Ranbaxy Laboratories, which I had once worked for, in a US court.

As a result of that case, changes were made to the US regulations and to the US regulator in how they ensure the quality of the US drug supply. Sadly, nothing much has changed in India; we continue to subject our people to poor quality, substandard drugs.

CC: Tell us about the philanthropic work that you are pursuing since the last several years.

My work is focused on building public health infrastructure in India and empowering people to defend their civil rights. My foundation works with many great people and organisations which do so much good work in these areas. We are collectively trying to make a small difference in the lives of people when it comes to their healthcare and their rights as citizens.

CC: What recommendations would you make for a youngster to choose the pharmaceutical industry as his or her career?

The pharmaceutical industry offers a diversity of opportunities for young people to make a good career. Pandemics like COVID-19 provide a good example of the kind of skills that are needed. Epidemiologists, Microbiologists, Data Scientists, Chemists, Pharmacists all have a role to play in providing healthcare in the country. Young people need to find a good institution and role models that help them develop the right kind of skills and capabilities to succeed in these roles.

CC: Your philosophy of life?

I don’t have a philosophy or something that laudable. I try to live by simple principles which help me, namely, always be honest, live a life with integrity and always give back to the society where you came from.