Pharma, biotech sectors over-regulated in India

BIOCON CMD Kiran Mazumdar-Shaw’s biography, Mythbreaker, by Seema Singh is also the story of Indian biotech. The book traces Mazumdar-Shaw’s journey as an entrepreneur, her risk appetite and a fearless approach to all challenges she faced in her three-decade journey. In an email interview with Ivinder Gill, Mazumdar-Shaw talks about the sector and how she does not see herself giving up control of the business anytime soon. Edited excerpts:

As an industry insider, how would you rank India’s healthcare facilities and quality of medicines available to the masses?

India’s pharmaceutical industry and private-sector hospitals are of international stature, both in terms of physical infrastructure and technical resources. Human resources are also commensurate with global standards. By and large, the quality of medicines produced by large and mid-sized drug manufacturers is of acceptable safety and efficacy standards as prescribed by the WHO (World Health Organization). However, government procurement for public consumption is often fraught with challenges ascribed to spurious or counterfeit drugs, as well as poor inventory control that may lead to expired drugs being dispensed. Several state governments like Tamil Nadu, Kerala, Karnataka, Rajasthan, etc, have implemented e-tenders for drug procurement that have addressed all of the above.

Sub-standard drugs is a big issue in India. How do you think this can be effectively tackled?

E-procurement tenders that stipulate a set of quality criteria, which combine elements of stringent specifications, quarantine, tracking, quality and inventory control help to minimise and eventually eliminate substandard drugs from the system.
The book mentions how you have had multiple encounters with cancer in dealing with illnesses of your loved ones. Was diversification to healthcare and starting a cancer hospital a business decision or was it more inspired by your personal experiences?
The transition from enzymes to biopharmaceuticals was a business-led strategic decision. The cancer hospital was a philanthropic decision based on my personal experience of losing my best friend to breast cancer, which opened my eyes to the critical needs of access and affordability in cancer care.

You have been a great advocate of public-private partnership in the healthcare sector. Could you outline your blueprint in this regard? How will it be effective?

There is a distinct role play for government and the private sector in delivering universal healthcare. The government must focus on health assurance through primary care and procurement of drugs, diagnostics and hospital services on one hand, and health insurance to reimburse healthcare expenses that range from immunisation to hospitalisation to acute and chronic care on the other. The private sector must provide drugs, diagnostics and hospital services in a partnered manner through tenders and service agreements. An e-platform that integrates all of the above through personalised health cards and electronic medical records will deliver transparency and accountability. The ultimate aim should be to link health coupons with healthcare spends at an individual level.

You have been vocal about the hardships faced by the Indian industry. Do you see things improving?

The pharmaceutical and biotech sectors are over-regulated. We need to segment regulations on the basis of ‘must have’, ‘nice to have’ and ‘need not have’. We have far too many extraneous regulations under the ‘need not have’ category, which need to be done away with. ABLE (Association of Biotech Led Enterprises) has started working with various regulators to categorise regulations into these three buckets and we are hopeful of streamlining the system to enable ease of doing business. I am very optimistic that things will significantly improve in the near future. There still remain some key challenges for the biotech sector, especially with respect to genetically-modified crops and the draconian National Biodiversity Act. Let’s hope this government will address both these in a progressive manner.

What future do you see for Biocon? Do you think the company will operate with the same risk appetite as yours after you give up control? And are you happy if it does not?

It’s too early for me to speculate, as I don’t see myself handing over control anytime soon! Biocon has always pursued a business path that is relatively risk-ridden and this, we believe, is why we are front-runners with very little competition. I hope this business culture of pursuing innovation that has intrinsic risk will endure beyond me.