Tailor-made regulatory process sought for biotech sector

‘Complexities of the industry should be addressed to encourage innovation'

February 07, 2012 11:23 am | Updated 11:23 am IST - Bangalore:

Karnataka Chief minister D.V. Sadananda Gowda and Union Minister for Health and Family Welfare Ghulam Nabi Azad greet each other. Photo: K. Gopinath

Karnataka Chief minister D.V. Sadananda Gowda and Union Minister for Health and Family Welfare Ghulam Nabi Azad greet each other. Photo: K. Gopinath

Members of the biotechnology industry and the Government concurred that the lack of a clear regulatory framework was hindering the smooth functioning of the sector.

At the inaugural session of the three-day Bangalore India-Bio 2012 on Monday, Kiran Mazumdar-Shaw, Managing Director Biocon, said that an efficient regulatory system was necessary to encourage innovation.

There were “unrealistic expectations” from the industry that only a proper regulatory framework could help realise.

Speaking to presspersons on the sidelines of the event, M.K. Bhan, Secretary to the Government of India, Department of Biotechnology, Ministry of Science and Technology, admitted that regulations for the BT sector should have been in place ten years ago.

Improving the regulatory process for BT and the biomedical sector and addressing their complexities were important, especially now that India is emerging as a favoured destination for research and development in the sector, he said.

The problem arises from the fact that the regulatory framework for the pharmaceutical industry has been applied to the BT industry. “The BT industry is more complex and we can't apply the existing regulations for it,” he said. Mr. Bhan hoped that the long-pending National Biotechnology Regulatory Authority of India (NBRAI) Bill, at present before Parliament, will soon be enacted.

Task force

The Centre has constituted a task force to frame regulatory guidelines for the industry, Union Minister for Health and Family Welfare Ghulam Nabi Azad said. The task force aims to adopt a holistic approach towards solving concerns of the industry, he added.

Incubation hub

Speaking at the event Mr. Bhan said that in order to nurture young talent, the Centre will soon set up an incubation hub near the National Centre for Biological Sciences in Bangalore. Bio-connect will be part of eight new centres for incubation in the city, he added.

A state-of-the-art biotech park — the Alexandria Knowledge Park — within Bangalore Helix, will be operational in about two years, said Chief Minister D.V. Sadananda Gowda. A world-class incubation centre and a common instrumentation facility are also being set up in Bangalore Helix, he said.

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