14 January 2022


A Man for All Seasons

Yogesh: “My advice is to go on with your life -- a non-living chemical entity should not block the joy of inhaling fresh air.” That was your recent recommendation to those worried about the virus. There are many experts who have a grimmer prognosis. What is the root of your optimism?

Dr. Niazi: My observation stems from the simple fact of virus being in existence before cells came into being and will remain when we all are gone. It will take a bit of understanding as to how this phenomenon is pure chemistry, and how a chemical may be formed automatically and goes on to generate itself. The last big episode of an outbreak was a 100 years ago with the Spanish flu originating in New York and with more than a few million lives lost. We need to work around it and not let it transform our lives. This means each individual needs to make sure they don’t spread it through being fully vaccinated, having booster shots as required.

Eventually, why we need to have an optimistic view is the fact that you cannot fight something that is non-living and just a chemical.

Yogesh: What according to you is the difference in how developing and developed countries view biosimilars?

Dr. Niazi: Let me first acknowledge that India has done exceedingly well in this phase, making the vaccination, exporting them, making millions of dollars, learning and progressing through the pandemic.

When it comes to biosimilars, I want to dwell on the fact that there is going to be a significant change in terms of guidelines for biosimilars. After all, we have 15 years of record to prove that biosimilars are very safe. There is recognition today that just for an abundance of caution, you do not need to have this test and that. If the tests provide value, then yes, but if not, then why are we doing it? This year, the FDA has a new policy coming up in terms of new biosimilars not requiring testing on animals. Animals don’t have receptors, for them antibody is just an extra source of protein. In its place, the focus has to be on strengthening the analytics part.The onus will now be on companies to take this forward.

Yogesh: The Indian government is pushing the domestic industry to capitalize on the fact that COVID-19 provides a larger opportunity to shape the biosimilar landscape. What policies and regulations would help build such a landscape?

Dr. Niazi: From a purely broader outlook, I would like to see the Indian agencies be a little more practical and realistic in keeping with the times. If I were to approach the US FDA for testing people for drug efficacy with the ‘real’ drug and a biosimilar, the agency would probably tell me it will be unethical to do so, and that I could test side by side. If you can check for side effects and have a look at the antibody profile and if you can match the profile of those given the real drug, then that’s a go ahead. This sort of approach will be a wonderful opportunity to create mRNA vaccines that function differently from traditional vaccines. I anticipate a lot of such vaccinations for auto-immune diseases. We still have no such vaccines for Alzheimers’,diabetes and the like – and no country requires biosimilars more than India. And I do believe this is a marvelous opportunity for India with over 120 products’ patent and exclusivity expiring soon. India can definitely make them with a supportive regulation. Again, it needs to focus on the export market to make it commercially viable. After all, a product that is good for anyone, should be good for everyone, across the world!

Yogesh: What are your thoughts on the potential collaborations between Indian and Foreign Players, especially when the government’s growing focus is on incentivizing domestic manufacturing and Atmanirbharta?

Dr. Niazi: You know, I recently finished a research paper on Covid support where US has spent 4.3 trillion dollars, which was more than the US budget in 2019. The world invested 12 trillion dollars on Covid support. A significant amount of the money went in support, research, development, buying drugs, improving health infrastructure. Different countries also came together to develop the vaccine. So, this is how it needs to be in today’s world. Governments must come together to motivate and bring in innovations.

India has so many entrepreneurs, brings immense competencies, and money too is not an issue in many cases. However, 70-75 per cent Indian entrepreneurs getting awards for innovation have been based in the US. This is because of the innovative culture there that enables entrepreneurs to take risks, fail fast and yet, look towards the future optimistically. I believe currently India is almost on a breaking point with regards to this culture. The country has expertise few others do but we still have to imbue a resilience towards fearing failure and striving to make a product globally approved. This is something we can learn from an atmosphere of collaboration.

Yogesh: What should India then focus on to grow this culture?

Dr. Niazi: Studies have found that one of the least innovative countries is Japan: they believe in taking technology and really putting it into practice. China too doesn’t have innovation but 90 per cent of their products have entailed successfully customizing an innovative product to meet their needs – commercial or otherwise. Let me tell you, I am not discouraging innovative thinking. What I would like to say here is one needn’t try to bring in an entirely new process. Leverage what brings commercial value to you. India has a long history of Nobel laureates, it understands the trends as it understands the global language, English better than many others. I would advise it to identify its own niche and seek commercialisation of these innovations.

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