‘The present system is not sufficiently innovative’
Dr MK Bhan, Secretary, Department of Biotechnology, is an eminent scientist who has developed a rotavirus vaccine based on neonatal strain, and a low osmolarity oral rehydration solution, introduced recently in the Diarrhoeal Disease Control Programme by the World Health Organisation and the Government of India. Sapna Dogra talks to him on the status of biotechnology and the regulations in India
The biotech industry has been upbeat lately with innovations. How do you rate its progress?
The industry is growing steadily. Several areas, including enzymes, vaccines and to some degree in diagnostics, have seen success, although the volume is not large. In manufacturing and services (clinical research, clinical trials and contract research areas), we are improving but still below our potential.
While we produce a sufficient number of postgraduates in life sciences, unfortunately we are not producing enough PhD students. We have deficient human resources in specific niche areas like IPRs, technology transfer and industrial microbiology. If we could add 200 scientists of international quality in life sciences, it will make a huge difference.
We do not have institutes in some areas such as animal biotechnology. We have good animal husbandry personnel but we need people who understand animal health and modern biotechnology. In celebrating the success so far, you are not recognising how much bigger it could be. There are challenges of how to exploit opportunities. Therefore, the balance sheet is a mixed one.
What about government support for research and innovations?
The quantum of government support for innovation has increased with the Pharma Fund, CSIR grants and DBT’s newly introduced Small Business Innovation Research Initiative (SBIRI) scheme. Interest rates have been reduced to two percent for late stage development in SBIRI, which is the lowest ever. Government support for industry research, in partnership with the public sector, is receiving more attention.
How have the schemes been welcomed?
We have just screened 30 proposals from companies for SBIRI funds. The idea is to spread centres of excellence. It is part of re-engineering the existing institutes to become more managed and innovative. It is not just about money, but money with reforms, which is why we have imposed very tough conditions. Our goal is to create more science centres in medical and agricultural institutions, and more technology centres in science institutes. The present system is not sufficiently innovative in our new biotechnology strategy and there are many ideas on how to increase innovation in India. In fact, we have started implementing some of them, including the SBIRI and increasing the number of PhDs. We will support anybody who is willing and competent.
What is the status of stem cell research in the country?
Unfortunately, India lacks the institutional structure for good stem cell research. Currently, there are about 100 projects on stem cell research. Here, we are working in partnership with the industry by looking for companies to produce stem cells following GMP. We have been able to put a stem cell strategy in place in which both academia and industry have a role to play.
DBT has funded National Centre for Biological Sciences for training institutes in stem cell
We have established a three-tier system for evaluation of clinical proposals to ensure patient safety—a basic science committee, an ethics committee and a clinical committee. Institutes require dedicated faculties for stem cell research. Recently, DBT has funded National Centre for Biological Sciences for training institutes in stem cell. Similarly, we are supporting PGI Chandigarh, SGPGI Lucknow and KEM.
We have a number of projects at AIIMS. However, each of them has been told to reform their practices through these three committees. In embryonic stem cell research, the critical mass of scientists is a little disappointing. Next year, we will create a dedicated institute for embryonic stem cell research. We have consulted globally and now we understand this game.
Please tell us about improvements in regulations?
We have simplified medical regulations quite a bit. It is a more scientifically oriented policy, which considers the level of risk and avoids unnecessary scrutiny where risk is minimal. Wherever the final products are proteins, the regulatory processes will be much simpler now. We have made significant improvements in protocol that will bring a lot of relief when they are introduced, which will be very soon. We need to pursue the idea of a truly independent, well- managed and well-funded professional scientific regulatory setup such as a single national regulatory authority. Pushing everything to the drug controller’s office will not work because he needs more resources.
What are your plans for DBT?
I plan to make DBT more innovation-oriented, and create more funding mechanisms to spur innovations in the system. Also, we want to support small and medium industries for research in a big way and partner with them aggressively. I want almost 25 percent of DBT money to be spent on this so that a scientist entrepreneur has a good chance of survival in India.
I want to break the barrier between government, academia and industry, and create a climate where knowledge can diffuse freely.