Indian biotechnology research and development must gear up and shift emphasis from an imitator to an innovator and ensure an entry into novel and productive drug development. So far, Indian companies invested in R&D for a tax shelter. Research has never been a business till Biocon considered R&D as the lifeline of its business. We need to portray researchers and their capabilities instead of the infrastructure at our scientific research institutions. If the R&D sector needs to become an innovator, it is imperative to invest huge amounts of money, stated Kiran Mazumdar-Shaw, president of the Association of Biotechnology-Led Entrepreneurs (ABLE), head, Karnataka Vision Group on Biotechnology and chairman and managing director, Biocon Limited in an interview with Nandita Vijay. Excerpts:
How would you describe the current R&D scene in the country?
Pharma-biotech research sector is trying to transform itself from an imitator to an innovator. Investments are growing exponentially and there is lot of focus on innovation-led discovery research. Pharma companies are spinning off their R&D divisions as separate entities. Despite positive developments, the stock markets are not yet comfortable with the research model.
We see lot of interest among young entrepreneurs to set up bio-research ventures, but venture capitalists in India are still not supportive of their models. What is your view on this?
Investors must realise that when they fund biotechnology start-ups they cannot expect a de-risked model. Venture capitalists in India are only used to a risk-mitigated model of the information technology companies, which is a services sector. With the pharma-biotech sector in the country becoming global, we need to kick-start the investor community and convince them to buy into this model. The whole business of pharma R&D takes a long time for gestation, is fraught with risk and is unpredictable. In India even the governments are still not serious in supporting such novel businesses.
What are the issues affecting the biotech research sector?
Companies need to be aggressive and look out for novel drugs and tap opportunities abroad. Today, Biocon has managed to grab potential market opportunities to develop novel products. But we are drawn into focus on company's fall in revenue generation because of statin pressure.
We have an exciting line-up of products in the pipeline for oral-insulin, oncology, organ transplant and MAB. We have tied up with Bentley, Vaccinex, Nobex and CMIAB, (Centre for Molecular Immunology), Cuba. We are all set to launch a one of a kind novel product for the first time in the country called HR-3, a monoclonal antibody developed with the Cuban monoclonal antibody and cell culture technology major, to treat head and neck cancer.
What is the status of the National Biotech Policy and the Karnataka Biotech Policy?
There is no attention to its execution .The government has to enable it. A part of the policy document like the SBRI, which is beneficial for small-medium biotech units and the tie-ups between CMC Vellore and NCBS have become a reality because of Dr.MK Bhan, secretary, department of biotechnology, government of India.
What is the latest on regulatory process for recombinant products?
Despite the Mashelkar and Swaminathan Committees working on the regulatory process for the recombinant products, the matter is pending before the ministry of environment, which has no role in approving a pharma-biotech regulatory framework which does not include agriculture products. These recombinant products are for critical and life saving diseases. With the result of this delay, we have lost all the advantages of clinical development. Now it takes twice as long to develop a drug in India than any other western country. Now we have lost all the advantages of speed in patient enrolment and cost base of the clinical development because it is taking so long.
How do the multinational companies react to the time lag in conducting clinical studies in India?
Since multinational companies are here for phase 2 and phase 3 trials, for which they have already done the most important part in another country. It is the Indian biotech companies that are trying to develop new drugs, that are hit. Biocon has lost three months' time due to bureaucratic delay in clearing oral insulin human trials. Biocon has also been collaborating with European companies for clinical development to speed up approvals primarily because of the lack of a large animal facility and secondly due to a delayed regulatory consent despite the costs involved only because time is more valuable than the cost.
What has happened to the Biotech Park in Karnataka after all efforts put in by the Vision Group?
It has always remained on paper. Poor focus and lack of support from the state government has led to a loss of advantage. Governments will be voted out if they don't provide infrastructure.
What, according to you, is the future outlook for biotech industry in the state?
The state is growing in spite or despite lack of government support. The total number of units in Karnataka is around 150 and the number of companies in the country is close to 300.