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'Lack of regulation hurting biotech sector'

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BS Reporter Chennai/ Bangalore

Lack of proper regulatory framework, among other hurdles, the biotechnology (BT) industry is having to surmount, is affecting the sector and its growth. The government will have to move fast and speed up growth of the Indian BT sector as it has the potential to emerge as a leading sector, said Biocon Chairperson Kiran Mazumdar Shaw on Monday.

Speaking at the inauguration of the three-day Bangalore India-Bio 2012, inaugurated in Bangalore on Monday, she said, “Only a proper regulatory framework would help realise these expectations. The regulatory system was necessary to provide support for innovation.”

India has made great strides in drugs, both patented and generic, while a good progress has been made on the vaccine front. Agriculture challenges have been addressed and India has now emerged as a net exporter of Bt cotton and the success of Bt cotton has resulted in pesticide imports falling, thus impacting eco-sustainability.

 

She said there was an enormous opportunity for BT in the energy sector which could help bring down dependence on fossil fuels. Ms Shaw said, as an emerging bioeconomy, India held a huge potential.

A holistic ecosystem has been created for the sector. But it lacks seeding fund to proof of concept, or venture capital funding to proof of concept. The complete funding cycle is important and needs to be addressed. She, hence, recommended the need for a stock exchange, on the lines of the Nasdaq, that would help secure start-ups secure funds.

Meanwhile, Union Minister for Health and Family Welfare Ghulam Nabi Azad heeded the concerns of the sector, saying the Task force for framing the regulatory guidelines had already been constituted. “The task force would have representatives from private sector, global corporations and the domestic industries. This would ensure a holistic approach to address the concerns of the sector in the country,” he said.

On the issue Dr M K Bhan, Secretary for Department of ITT and Science and Technology, said there was one set of regulations for both the pharma and biotech industry. “BT is more complex. The regulations for the BT sector should have been in place. I hope the long-pending National Biotechnology Regulatory Authority of India (NBRAI) Bill, before the Parliament, would go through soon,” he said.

Dr Bhan said, looking at the prism of the bioeconomy, the country was witnessing a higher job creation and public health through cheaper vaccines are already being witnessed. He was concerned that a cheap cancer treatment still eluded India and the country has to develop this as fast as possible, he added.

Public funding does not or cannot afford cancer research and private sector participation is inevitable, he added.

‘’We need to change the institutional system in the BT sector as about 80 per cent of the scientific investment by the government does not create Intellectual Property while only 20 per cent of the investment creates 80 per cent of IP,” he said.

Dr Bhan said that Phase II strategy for BT and biopharma sectors was being worked out by the Union government which includes improving the BT infrastructure. ‘’The government will come out with strategy papers to address the issue of bio-manufacturing by May 30 or latest by June15,” he said.

Speaking to reporters on the Antrix-Devas deal which has had the scientific community up in arms over the ban on the four space scientists from government work, he said, the process of making judgements on PPP agreements should be made with a calm mind and scientists should not get overexcited. Among the four scientists to be banned are former ISRO chairman N Madhavan Nair. Dr Bhan was speaking on the sidelines of the Bangalore India Bio 2012 that began here in Bangalore on Monday.

He said, there was no need for the scientific community to get disheartened by the ISRO case and denied that their morale had taken a hit.

“This (Devas deal) is a sure way for us to learn to handle the PPP models,” he said.

“There is no controversy on this (Antrix-Devas deal). It has been sensationalised,” he observed.

On the scientific community’s lack of knowledge in doing business with the private sector like entering into PPP models, he said, the relationship between industry and science has become important as whatever the scientific institutions do, it has to be executed by the industry.

“So we have to bridge the gap with the industry. I have seen major projects taken up by private sector in the last 18 months. You need to adapt good processes for PPP models. It is a government responsibility and scientific community will have to understand it,” he said.

He, however, said that audit systems that suit the PPP was yet to mature. The government had been evolving processes and audit systems suited for the PPP model as it needs a separate yardstick and judgement. ‘’When errors are made by individuals like scientists, it is important that they learn from the errors and correct themselves,” Dr Bhan added.

He said, there was no need for the scientific community in the government sector to get disheartened on the ISRO issue and engage on such issues with a calm mental make-up.

“Prime Minister Manmohan Singh is the greatest supporter of science and his contribution to the scientific field and its community for the last seven years can match the contribution of country’s first prime minister Jawarhalal Nehru. Dr Singh is a great believer of science. If you think that any scientist will lose confidence in him, never,” he asserted.

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First Published: Feb 07 2012 | 12:18 AM IST

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