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Biotechnology will take the country into the next big global league : Dr Cyrus Karkaria

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Biotechnology  will take the country into the next big global league :  Dr Cyrus Karkaria
By Dr Cyrus Karkaria,
President of Biotechnology at Lupin Limited.

Biotechnology is a confluence of diverse fields such as life-sciences, engineering and technology. Using biological systems as tiny as invisible cells and microorganisms, technology can be leveraged to produce desired products.

Biologics are manufactured in living systems and they require significant demonstration of safety and efficacy by regulators. The regulatory development requirements for biosimilars are quite unlike that of generics as biosimilars require extensive development and lengthy clinical trials with significant investment across the value chain. This makes affordability, the key premise of biosimilars, quite challenging.

Biotechnology is the new sunrise sector in India and is poised to take the country into the next big league of global companies. The biotechnology ecosystem in India is on the brink of becoming a major global force in terms of manufacturing and research capabilities. We’re witnessing dynamic changing trends such as large acquisitions by multinational companies in India, increasing investments by domestic and international players in India, deeper penetration into the rural markets, growth and availability of healthcare and incentives for setting up special economic zones (SEZs). The Indian Biopharmaceutical industry can definitely boast about its cost competitiveness, fast growing manufacturing base, intellectual capital, strong marketing and distribution network in domestic as well as international markets, in addition to world-class research institutes which help support the industry with skilled and technically competent personnel.

These trends combined with India’s huge population base, growing literacy and awareness for health, increased purchasing power, growth in healthcare financing products and access to good quality medical care will continue to propel the domestic Biopharmaceutical industry to newer heights. Moreover the Indian population is experiencing a major shift in disease profiles. With increase in affluence, rise in life expectancy and the onset of lifestyle related conditions, the disease profile is gradually shifting towards the chronic diseases segment.

India is becoming one of the most favored destinations for collaborative R&D, bioinformatics, contract research and manufacturing and clinical research as a result of growing compliance with internationally harmonized standards such as Good Laboratory Practices (GLP), current Good Manufacturing Practice (cGMP) and Good Clinical Practices (GCP).

R&D in India is getting more innovative with the first set up of Made-in-India biologics approved. A well-defined regulatory framework, along with an emerging stringent IPR regime is also contributing to this trend. Foreign investment has driven the clinical trial outsourcing along with strong clinical trial data management. Thus domestic companies have strengthened their position in the world for supplying solutions across the value chain.

India has recently joined the U.S., U.K., China, Canada and South Korea as one of the only countries to have successfully decoded the human genome indigenously. Moreover, concrete steps taken towards setting up of national research laboratories, centers of academic excellence and several other institutes in medical science, educational and training institutes offering degrees and diplomas in biotechnology, bioinformatics and biological sciences have given a boost to this sector.

To be able to become a global biotechnology hub, India needs to ignite the potential of the biotechnology industry and take it to the next level. This will call for several imperatives.

  • Foremost among them is to fire innovation in our research labs. We must take bold national initiatives in several frontier research areas of biotechnology, such as genomics, proteomics, pharmacogenomics, cell biology, tissue engineering, biopharmaceuticals and plant metabolic engineering. Designing relevant course content, imparting the right skills and selecting suitably qualified staff can help in inculcating the industry specific skill sets among students.
  • India must work to create such a favorable climate for attracting and managing investments, which in turn fuel innovation. To sustain innovation and leapfrog to the next level, Indian players will have to focus more on preserving, optimizing and investing capital, along with raising capital. Improving operating efficiency and building top-class infrastructure will be required to efficiently utilize capital amid funding constraints.
  • Biotech companies in India will need to build credibility as trusted and transparent partners by ensuring stringent measures to close inherent gaps in their operations. India’s regulatory and intellectual property regimes must be in sync with global requirements. Adopting a Quality Framework in line with global norms will be critical if Indian companies are to become partners of choice and for promoting exports around the world.
  • Another imperative is to develop biotechnology solutions in an affordable manner and the eventual translation of research ideas into commercially viable projects. This must be achieved through the creation of an ecosystem that nurtures scientific expertise and the development of public-private partnerships that bridge the gap between academia and the industry.
  • As the healthcare industry increases its accessibility to rural areas its impact is felt across ancillary sectors – from diagnostics, education, data management, new technologies and logistics (Cold chain). Moreover, patients have evolved from passive recipients to “super consumers” and are seeking methods and support to manage their own health outcomes. Existing examples such as educational websites, smartphone applications, innovative medication reminders and online patient communities can serve as preliminary platforms for companies through which to create awareness among patients and become trusted “health managers.”
  • Meticulously tracking the changing global landscape, adapting quickly to change, and reinventing business models will require significant creativity and flexibility. Thus the final imperative for India is to create a conducive environment for global partnerships for joint IP generation, harmonizing Indian regulatory guidelines to meet global norms, smooth movement of biologics and leverage better markets for biotech products and processes.
  • Over last couple of years, India has emerged as a leader in startup arena which is a reflection of new, innovative entrepreneurial talent. This culture needs to be nurtured which is possible only if we reward this talent and create a business environment in which commercial exploitation of new ideas are realized with ease. Only then can tomorrow’s giant businesses emerge from today’s unicorns.



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