'Red tape stifling India's biotech sector'

Bangalore Bio 2003, the three-day annual event of the biotechnology industry, kicks off on Tuesday). Kiran Mazumdar-Shaw, chairperson and managing director of Biocon India and one of the prime movers of the young industry, spoke to Subir Roy on the issues before it.

Why are Indian biotechnology companies finding it increasingly difficult to access funding?

The long gestation time lines in product commercialisation, capital-intensive projects profiles, poor understanding of the sector and the small size of the Indian biotech market are all factors that profile biotech as a risk ridden segment for funding.

There are very few profitable biotech companies in the country, which adds to this apprehension in the financial circles.

How serious a handicap is the loose regulatory system leading to unethical competition (witnessed in the case of the Hepatitis-B vaccine) and bureaucratic delays in approval of products at various stages of development?

Bureaucratic delays are stifling growth in the sector. India should be far more aggressive in launching 'look alike' biological molecules in a fast track manner. I don't think our regulatory process takes short cuts. In fact, I think they are being extremely stringent in evaluating technologies and products, especially after the controversies surrounding Hepatitis B and GCSF.

However, I think there is a need to streamline the regulatory process where the roles of the Genetic Engineering Approval Committee, Review Committee of Genetic Manipulation and Drug Controller General of India should be more clearly understood and prevent duplication and unnecessary overlapping of approvals.

We are working towards resolving this by demarcating the boundaries of R&D, clinical development and commercialisation.

Almost all the bio-pharma companies are concentrating on narrow product lines such as streptokinase, erythropoitin, GCSF, interferon alpha and insulin, which may lead to market fragmentation. Your comments.

Yes, this is of concern in one dimension but I believe that technology will be a differentiator in the long term and those with poor R&D capabilities will not be able to sustain their businesses.

What is important in biological manufacturing is to develop high capabilities in recombinant microbial and mammalian cell culture to enable companies to move from imitation to innovation.

The Rs 400 crore (Rs 4 billion) domestic bio-pharma market has thus far seen only 3-4 new products from local companies. Other products have been in the pipeline for years. Why this pace of progress?

We need critical mass in the biotech sector, both at the R&D and market levels. A large domestic market will provide the incentive to invest in larger manufacturing plants. At the moment, most companies are producing biotech drugs at pilot scale levels. This cannot hope to turn India into a global player.

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