I am running into my seventieth year. Born on February 10, 1955, I have lived a somewhat uncertain life with some cardiac electrophysiological issues since childhood and, later, coronary artery disease that necessitated multiple angioplasties, a bypass surgery, and two stents…
The Writing on the Wall
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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