The Writing on the Wall
I have been a frequent traveler and for many years, especially from 2000 onwards, there was hardly any week without travel. My association with Dr. APJ Abdul Kalam was a powerful facilitator and during his Presidency (2002 – 2007), I had been to every single state and Union Territory of India and joined his entourage to Singapore, the Philippines, South Korea, Myanmar, and Mauritius. I also went to Japan in 2004 to prepare for his visit, but it did not take place.
After my stable angina become precarious in 2019, I was grounded at home. Accepting the situation rather stoically, I withdrew myself from the happenings around me and focused on writing books. Working diligently, I could publish India Wakes with Bart Fisher; Diamonds Are Forever, So Are Morals, a biopic of Govind Dholakia, with Kamlesh Yagnik; Decoding the Pandemic with Prof. Seyed Hasnain; and Win Locally to Succeed Globally with DA Prasanna. I did Simple Spirituality on Kabir solo.
Then, the rising star of robotic cancer surgery Dr. S. Chinnababu met me, and inspired by his journey, I wrote Living for a Legacy. It is being reviewed by global cancer experts and will be published later this year. Even after the book was done, several thoughts remained with me – how cancer will always be present despite avoiding tobacco and other carcinogens, and how, as more people would be saved by advanced treatments, they would need medicines to remain free from a cancer rebound.
Recently, Amit Kaptain visited me. Tall and handsome, the CEO of Vadodara-based Ami Lifesciences was born in Mumbai, while his parents hail from Umbergaon on the border of Gujarat and Maharashtra. He did his schooling in Mumbai and after graduating in science and completing an MBA from SVKM’s Narsee Monjee Institute of Management Studies (NMIMS), Amit started his career with E. Merck, handling the sales of Lab and Specialty Chemicals and Equipment for about five years. In 1997, Amit created his own enterprise in indenting APIs, chemicals and intermediates for the industry and exports of formulations.
In three years, he lost most of his money and landed up in Sun Pharmaceuticals, selling their APIs and formulations in the Far East and Southeast Asia. In 2006, Amit joined Ranbaxy and worked there for close to eight years. By 2012, he became head of the global API business. In 2013, when Ranbaxy was in turmoil, and was eventually acquired by Sun Pharma in 2014, Amit moved to Dr. Reddy’s Laboratories in Hyderabad and rose to become their Executive Vice President and Global Head for Sales and Marketing. He quit Dr. Reddy’s in 2000.
Are we hostage to China when it comes to APIs? Amit gave me a broad smile and said, “No way.” India is way ahead of China in chemistry and there is nothing that Indians can’t do. Right at the time a patent is filed anywhere in the world, Indians know how to crack it and wait in patience for it to expire. Of course, with the arrival of biologicals – extracted from, or semi-synthesized from biological sources – in the pharmaceutical industry, the situation is changing. Indians are not yet equipped to create biosimilars and even after the patent expiry of biologicals, they are still not challenged by Indian companies and continue making money in the market.
So, what is wrong? “A lack of innovation!” said Amit, as plainly as one would say that the sky is blue. His answer made me straighten my back. As a pupil of Dr. Kalam, an undisputed hero of innovation in India, my first reaction was of disbelief. How could it be? But as I dove deep into the situation, I could see the reasons and why they were there, and how we could come out of the impasse.
Innovations are different from inventions. Innovations are new ideas, methods, or devices around something that already exists. While chemistry was around in India right from the beginning of the twentieth century when Prafulla Chandra Ray established Bengal Chemical & Pharmaceutical Works Ltd. in 1901, biologicals in India were limited to Hepatitis B vaccines and insulin. There was no base to evolve.
China made the most of the opportunity. Its deep links to American academics and research have helped it grow, in part through absorbing knowledge when it was being created and developing new advanced gene therapy drugs and other pharmaceuticals even before American companies could do so. A patent has a basic term of 20 years from the date of filing, which usually happens several years before a drug is authorized.
Because of the intricacy of biotech drugs, which are created through biological processes involving recombinant DNA technologies, they are frequently referred to as “biosimilars” rather than generic copies. One of the first big biotech drugs to lose patent protection will be Enbrel, for example. It is a rheumatoid arthritis drug sold by Amgen and Pfizer Inc., with a market of $3.5 billion a year. Roche’s cancer drug Avastin, with annual sales of around $6 billion, will be the next.
So, what is the way ahead for India? Three steps can be clearly seen. The first step is to acquire crucial platform technologies and relocate them to India as urgently as possible, as it could have better been done yesterday. Then, a fast-track approval process should be put in place, especially for life-saving cancer drugs. Finally, all the drugs that are going off patent must be Made in India, supported by PLI (Production Linked Incentive) and RLI (Research Linked Incentive) schemes. Such proposals from the industry must be preferred over other drugs.
India is blessed with immense biodiversity. We have the sources in our plants and trees for making most modern biologicals. By putting the genes from these plants into yeast-like mediums, these can be grown faster and cheaper. In the interest of the nation, export of all such materials and extracts must be prohibited for at least a decade and all drugs used in the treatment of cancer must be declared essential and regulated. This will set the ball of innovation rolling.
There is a scriptural account that while the king of Babylon, Belshazzar, was holding a feast, a mysterious hand appeared, writing on the wall of the king’s palace. The monarch summoned the wise man Daniel, who interpreted that the king needed to learn his lesson lest his kingdom fell.
Nothing happens in this world without a cause. For innovation to happen, there ought to be platforms, people, support systems, and above all, motivation. While the industry works for profits (and why should it not?), governments must work in the interest of people, especially the poor, and even more so for poor patients, who must get the best of the medicines they need.
Innovation is now a must-have, not just a nice-to-have. The economic equivalent of “survival of the fittest” has been replaced by “survival of the most innovative” as the new Darwinism. The writing on the wall reads that India lacks the capacity to manufacture novel biological drugs. It is regrettable that out-of-patent medications are enjoying protection period pricing in the Indian market simply because Indian companies are unable to produce cost-effective biosimilars. If correct action is not taken now, India’s fate would be sealed, as happened in the case of the tyrant and indulgent king of Babylon.
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Dear Professor Tiwari sir, the way you are encouraging and advancing the youth is highly commendable. Very happy to read about Amit Capt sir , Tiwari Sir I wish you good health always and good progress Amit Sir & Ami Group
Respected Tiwari Sir, I have read your many blogs. This was really different than others because in India the Pharma companies are not putting their efforts on research and development to produce quality drugs for poor Indians. I am sure that your article will generate little attention to innovate new drugs with the help of the established packages and practices in India. Our best wishes for your healthy life.
Excellent insight into the intricacies of biotech drugs, Prof Tiwariji !
Your clarion call to indigenously manufacture novel biological drugs will go long way in getting the best of the medicines for the needy!!
Sir I am not a pharma industry person, but I can see the point you have made in the blog. We live in a complex world – everything is interrelated, or rather interdependent. I think scaling is the main issue. What can be done at a small scale need not succeed at the large scale. It is easy for people to work and excel solo but making teams and undertaking tasks larger than individual capacity is challenging.
I have met very talented software developers, engineers, artists, and generally bright people, who are very good in whatever they do. But when it comes to working with the others they fumble. Is it their ego? Maybe not. They lack the capacity to work as a team which is a soft skill. The message I draw from this blog is to scale up innovation to industry scale.
If I take a tour of Hyderabad on my bike, I can see a scientific laboratory in every major locality. There are clusters in places like Rajendra Nagar and Tarnaka. So, why has the work done in these places have found application in industry? Why is the issue of self-reliance not settled even after 75 years of independence? Thank you for raising an important point. Younger generations must rise to the reality.
Dear Sir, This makes an awesome read, that’s not only informative but also thought provoking and future looking.
Wonderful read sir!
The recent USP (US Pharmacopeia) report highlights the US’ reliance on large Indian manufacturers for APIs. Over 80% of all APIs for essential medicines used in the US have no domestic manufacturing source, with the US relying heavily on API manufacturing sites in India and China for crucial ingredients. There are 114 facilities in India making more than 30 active US-approved API products. Another 183 Indian facilities are making more than 10 APIs. In comparison in China there are only 4 and 35 facilities working for the US companies. Less than 5% of large-scale API manufacturing sites are in the US. India will be committing a blunder in surrendering this great opportunity. As you said, ‘writing on the wall’ is already there.
Sir, thank you very much for narrating the powerful story of ‘writing on the wall’ included in the story of Belshazzar’s feast in the Book of Daniel in the Old Testament. A mysterious hand appears and writes on the palace wall four coded words. Belshazzar on behest of his wife calls for Daniel, a sagacious wise man and asks if can help? He will be richly rewarded, tells the king. Daniel tells the king that he requires no riches, and the king can give his reward to someone else, but he will divine the meaning of this writing for the king, nevertheless. Daniel promptly interprets the meaning of these enigmatic words – ‘you have been weighed in the balances and found wanting’, implying that the Babylonian’s empire’s days are numbered. Sure enough, Darius and his Persian army invade, and Belshazzar dies. I can see the situation of the modern pharma industry and its fascination with profits very clearly. The Indian Pharma industry must read the writing on the wall. Thank you once again.
Dear Arun Sir, It was wonderful to meet up in person and a lot of gratitude for sharing the wealth of your knowledge, experience & thoughts which was a huge learning in that short time we spent. Looking forward to your continued guidance.
A very thoughtful and timely blog Sir, written with clear thoughts and in transparent words. Various factors are favourably contributing to the pharma market growth in India. Government initiatives such as Pradhan Mantri Bhartiya Jan Aushadhi Pariyojana and Ayushman Bharat Yojana under National Health Protection Scheme (NHPS) are helping the poor while supporting industry. One of the most notable measures taken so far was the introduction of the PLI Scheme in a bid to promote local manufacturing of APIs, Key Starting Materials (KSMs), and Drug Intermediaries in India.
Thanks to the PLI scheme more local manufacturers can now access incentives and support needed to participate in the API sector, so far dominated by big companies and imports. With 80 per cent of new drugs being approved globally being biologics, the expansion of manufacturing scale should not just aim at catering to the domestic market. Companies need to be able to tap global markets, for which India needs a strong policy that provides incentives for exports. The trend of Indian start-ups going for Drug Master File (DMF) testifies this. Your ability to access the minds of people and make them comfortable in sharing their views is such an amazing quality!
Respected Arun Tiwari Sir , Thank you very much for being you!!. I am regular reader of your blogs, Articles published in various publications from time to time , Facebook posts & Books . Which gives me an authority to talk about uniqueness of unique in you. The uniqueness in you is each & every writing of yours taught us unique lesson . Since last many years , I have been articulately introduced about world ,peoples , ideas & various subjects of science , technology , literature , spirituality etc., which would have been impossible to self explore without your writings.
The way you writes , creates spark in me to understand subjects , which I have not encountered & unfamiliar with , As a result I completely dive by reading & re-reading your writing . Some where I have read , Everybody benefits in his/her life enormously from others efforts . While reading this blog , this thought came in my mind . Thanks for lessons .
Sir, It is a wonderful concept to use fermentation techniques to produce APIs. Because bioreactors, which are expensive equipment, are involved, the industry is in a waiting and watching mode. In order to entice industry, our CSIR (Council of Scientific & Industrial Research) and NIPER (National Institute of Pharmaceutical Education and Research) systems should start experimenting with the production of APIs through fermentation.
The finesse with which we need to work faster, higher and farther summarizes the urgency of acquiring, capturing, reinventing, dissecting, reassembling and delivering in new dimension for public good. Time lost in not innovating takes toll on Nation’s progress and citizen’s welfare. Let us all commit to transform the knowledge for Nation’s growth wellbeing. Opportunities lost are milestones missed and regrets amassed.
Dear Sir, Very much agreed on the “survival of the most innovative” as the new Darwinism, and this is the main idea developed countries are working on. I believe India is now on that path and will become the world leader soon,
Dear Prof, Very frank and challenging.
Most of the countries in the South are looking to India’s innovations in this area. Generics from India have been lifesaving and cost-effective for developing countries.
Good learning for me.
Yes, we do have good chemists but making bio similars is some thing different.
While we have the talent, it requires a good platform for ‘take off’ One or two such innovations would definitely inspire many more.
The pharma industry has helped us during the ‘covid;’ crisis and ‘we’ the citizens and the government need to provide the right impetus for a revolution.
– a healthy nation, free from disease with an affordable medical care system is what is desired.
– We pray and look forward for that day
Very pertinent issue raised by prof Tiwari ji in this Blog on much needed innovations in API and biosimilars for our nation. It was so heartening to learn about mr Amit who is committed in this area and making his mark. I am sure whom so ever reads this Blog, will make a difference in times to come through his actions.