She may hold a degree in brewing, but Kiran Mazumdar-Shaw has always been a bio-technologist at heart. Biocon, one of India’s biggest bio-technology companies, stands testimony to her passion for and commitment to the science. The recently released book, Myth Breaker, by Seema Singh, is an inspiring biography of Mazumdar-Shaw that captures her journey as a bio-technologist and an entrepreneur. In a candid interview, Mazumdar-Shaw talks about her long journey as an entrepreneur, science, health and startups. Excerpts:
How do you look at your journey as an entrepreneur?
When I look back, all my hardships and challenges flash before my eyes. I want to convey one thing to young entrepreneurs—don’t get unnerved by challenges.
I am not an engineer, I am a brewmaster. I didn’t get a job as brewmaster, so I started my own company. I feel that young people give up soon after they face a big challenge. For a young entrepreneur, it is difficult to earn credibility with investors, but one needs to have credibility in one’s own mind.
You started Biocon in 1978. In all these years, how have things changed for entrepreneurs?
In the 1970s, the government did not even understand the concept of a startup. Businesses were started by rich and retired people. But, today, college goers are starting their own business.
Is it true that researchers in India don’t do applied research, and their only aim is to get their research published in a journal?
It is very important to do basic research to excel in applied research. To get your research published in a prestigious journal is fine, but the problem is we are not even publishing in prestigious journals.
We need to ensure that there is meritocracy in our research institutes. Unfortunately, all senior positions in most of our research institutes are held by administrative people and not scientists.
Why is it difficult for our scientists to take their molecules to the drug level?
The problem is we are doing drug research in a sub-optimal ecosystem. Not just researchers, even the companies face the same problems. Nobody wants to do clinical trials in India as it takes more than a year to get the initial permission. The regulatory system has introduced a large number of layers.
In India, the regulatory system faces a problem of manpower, not expertise. The regulators need to be strengthened with human resources. India can have the most robust system of drug development.
Is this discouraging researchers?
It has a lot to do with how the bureaucracy functions. A good research should be incentivised, but here we go by number of years, tenures. Nobody is bothered about the quality of research. We don’t have a reward and recognition system which is solely based on meritocracy, and not mediocrity.
Besides, good research is not possible with frugal resources. The west invests a lot in quality research; here people expect scientists to do the same research with one-tenth of the resources. But, I am happy that the wheels of change are in motion.
Where do Indian products stand in international market?
The pharma sector has done a commendable job. India is the world’s pharmacy. We meet 30 per cent of the world’s demand for generic drugs. We are the biggest producers of vaccines, insulin and biologics.
We can’t have draconian policies and be on the top. I was forced to set up a facility outside India, in Malaysia, four years back as it was cumbersome to get environmental clearance here.
But things are changing. The guidelines for biosimilars, stem cell research, clinical trials and drug delivery systems are being framed. Ideally, there should be a technical review committee and an appellate body, so that if one is not happy with the decision of the former, one can appeal to the latter. Right now, there are multiple bodies—technical review committee, apex committee, expert committee—which repeat each other’s work.
The rising cost of health care is a major issue.
We need partnership between private and public players. The government has to procure drugs in bulk; it has to come up with a universal health care policy, a mission to make drugs accessible and affordable, and an assurance and insurance mechanism. To stop forgery and substandard drugs from entering the market, the government has to come up with a robust e-tendering system.
You once had an ambitious project of developing oral insulin. That was close to your heart.
It still is. It failed at the clinical trial level then. But we have revisited the molecule recently. I realised that, probably, it was not the molecule that had a problem, it was the way we designed our clinical trials. We are working on it, hoping it becomes a reality this time.
In the book, you have said there are five molecules in the pipeline.
We have biosimilars in the pipeline. We see ourselves as diabetes specialists. We are working on bio-similar insulin. When our insulin bio-similar was approved in Japan, it was a great moment for us. We are doing a lot of research in oncology as well. We are currently working on a fusion antibody programme that could cure many types of cancer.
Politically, it was not the best of times for ‘foreigners’ to do business in India. Under the Janata Party, India had sent IBM and Coca-Cola packing the previous year and did not allow multinationals to own more than 30 per cent in an Indian company.
The following two-and-a-half months were spent trekking to and from Udyog Bhawan in Delhi. Nirmal Biswas, head of the Directorate General of Trade Development (DGID) under the Ministry of Commerce, the ministry in charge of approving any foreign investment or joint venture, advised her that the only way to get approval would be to have either import substitution or an export element explicitly listed in the project report. If both could be listed, chances would be higher.
‘For someone who did not even know what a joint venture was, getting import–export data in those pre-Internet days was daunting,’ she says. As she went around the corridors of Udyog Bhawan, touts followed her. ‘Madamji, you give it to us, we’ll make the project report and get the approval. You will not have to do anything,’ they would tell her in Hindi. They asked for a bribe of Rs10,000. ‘That was a lot of money in those days. Besides, I only had Rs10,000 in my bank to start the company,’ she recounts, sounding indignant even after thirty-seven years. As weeks passed, she began to get worried. The touts would rub it in every time she waited on the corridor benches: ‘You keep sitting here, nothing will move.’
Biswas gave her a handful of ministry of commerce publications which had data on what they were importing, and with some extrapolation, she figured out what her company could substitute for these. On exports, she was clear about what and how much she would be able to export to Ireland. Since he could not do much about the brokers floating all over the building, Biswas lent her a desk in a corner of his office and suggested she work there to avoid snooping characters in the corridors. She managed to make a simple project report. There were a few rounds of corrections. Her mother doubled as a driver during the day and a typist at night, incorporating all the changes that Biswas wanted on her Remington typewriter. By the end of October, Kiran had submitted her application.
By mid-November, she received a letter from Biswas saying that her application had been approved; the ministry intimated her by a telegram. This was fast even by today’s standards when it takes at least ninety days to start any venture. She wasted no time in applying to the registrar of companies, and Biocon India was incorporated on 29 November 1978.
Mythbreaker: Kiran Mazumdar-Shaw and the Story of Indian Biotech
By Seema Singh
Published by Harper Collins India
Pages 280; Price Rs 380