Most of the American biotech and pharma companies are sceptical of investing in India or entering into collaboration with Indian companies because of their concern over IPR (Intellectual Property Rights) issues. The government must address the regulatory and ethical issues related to IPR as soon as possible and make the world know that it was strictly implementing the international regulations like ICH and penalising the people who were stealing the technology. This was stated by Ckacko P Verghese, managing director, Bio-Technology International Limited Liability Company, BTI-LLC, Research Triangle Park, North Carolina, USA, in an exclusive interview to Pharmabiz.

Verghese was in Hyderabad to attend the three-day international Biotech Invest-2003. He signed four MoUs with Hyderabad-based companies for collaboration in the fields of technology transfer, contract research, pre-clinical and clinical research, access to new markets and capabilities, R&D outsourcing and so on.

Faced with increasing competition, declining profit margins and reducing product life cycles, biotech and pharmaceutical companies in the US were forced to lower product development costs, increase product life cycles and identify new markets for their products, he said. In view of this there was tremendous opportunity for Indian companies to enter into right partnerships for mutual benefit of US and Indian companies. The overheads would be very low in India when compared to the US.

Verghese said BTI had the expertise to assist US companies to gain entry into the development capabilities and sales potential of the emerging markets and vice versa. It would help US companies to get access to high-quality cost-effective production capabilities in Asian countries, especially India. This would help both the pharmaceutical companies and their consumers.

The world market for drugs was growing faster than the expected growth rate in the US. By using these strategies, the companies would be able to extend the life cycle of their products, increase sales volume and thus spread their R&D costs over more time and more volume.

For Indian companies BTI would act as a broker and arrange for contract research services, clinical research and product and process development services. It would also help them enter into partnerships and collaboration agreements.

Out of the 8 MoUs signed at the just concluded Biotech Invest 2003 in Hyderabad, four were signed by BTI involving DRS Systems, Bio Voice Knowledge Services, Sipra Laboratories and the All-India Biotech Association. One more would be signed with Magene Life Sciences in the coming weeks. BTI would provide guidelines for setting up data management components of clinical trials for DRS, help placing students and offer software services to Bio Vioce Knowledge Services, enhance laboratory testing facilities and contract research for Sipra and act as facilitator for AIBA members in getting technologies and products.

Verghese said BTI had helped Andhra Pradesh Chief Minister Chandrababu Naidu to sign two MoUs during his visit to the Research Triangle Park in February 2002. The first one was between the AP government and the State of North Carolina in the field of biotechnology transfers from the state-owned facility having several biotech parks. The second one was among BTI, AP government and Shapoorji Pallonji Biotech Park.The MoU had been converted into an agreement in December last enabling SP Biotech Park to open an office in the RTP and educate the US biotech companies about the biotech park in Hyderabad in order to set up their research units here.

BTI had helped ABL, a Hyderabad-based company to set up an R&D facility at RTP. ABL had harnessed the biodiversity in the Indian Ocean and domesticated certain algaes for the production of neutraceuticals such as beta-carotene, DHA and EPI. They also have anti-viral and three anti-cancer products that will be transferred into the US-based biotech company called ClinEra. BTI was helping ABL to get venture money and Incubator space at RTP.

Asked about other projects taken up by BTI in the country, Verghese said two projects were being finalised in Chennai – the Marina Biotechnology Park and the Botanical Biotech Park. The Canadian government would be participating in the projects and MoUs would be signed soon, he said. Another project was under study in Bangalore.

In order to give a boost to Biotechnology it was essential to have an Agency like Nasscom as in the case of IT. There should be minimum interference from the government. It was also very important to seek help from advanced foreign countries to set up biotech units and share their knowledge.

Verghese highlighted the role of universities in doing research in biotechnology. In India, the concept of doing research in universities and offering PhDs should be reviewed. The present system doesn't help anyone -- the university, the research scholar nor the industry.

He said three universities, Releigh, Durham and Chapelhill, were on the apex of a triangle, very heavily involved in life sciences, at Research Triangle Park These three universities interacted with each other and most of the multinationals were doing research there. It is a unique system, a cooperative programme and the tuition fee is subsidised by the industry. It has been said that if you throw a stone into the RTP, it will invariably hit a PhD or a pine tree. The technology developed in the universities are commercialised by the industry. India, he said, should develop something like this to promote research in biotechnology. It is too costly for the industry to pursue research in isolation in this emerging sector.