The CII-sponsored biotechnology delegation to Canada and USA has helped to identify partnering and outsourcing opportunities in contract R&D services, drug development, clinical trials and bioinformatics for the companies in India.

Kiran Mazumdar-Shaw, chairman and managing director, Biocon India Group and Head of Vision Group on biotechnology, government of Karnataka who was also the mission leader for the CII-sponsored biotechnology delegation to Canada & USA said that the acute funding constraints faced by the US biotech sector has created a real need for outsourcing lower cost R&D from countries like India & China.

"Indian companies currently have a distinct "English speaking" advantage which has not been fully exploited to attract more contract research services. China has been extremely aggressive in obtaining funding & grants from NIH and others, and India needs to catch up and alter the current ratio of 1:10 through a concerted effort. Contract R&D services alone has the potential of generating revenues in excess of $1 billion," pointed out Shaw.

Drug development is another large segment where Indian companies can carve out a niche. There is an even greater pressure being imposed on pharmaceutical companies to lower the cost of drug development. Added to this is the current trend in the biotech sector to veer away from the technology platform business model to drug development.

The immediate opportunity for Indian companies is in the area of pre-clinical and "proof of concept" clinical investigation. The larger opportunity is decidedly Phase 1-4 clinical trials but there are certain vital pieces of the regulatory infrastructure that needs to be put into place before Indian companies can fully realize this opportunity.

Schedule "Y" needs imminent amendment and India needs to fall in line with ICH guidelines in totality. International companies like Quintiles, Covance, Ikon, Clintec and others have already established a base in India in anticipation of this emerging CRO opportunity and Indian companies are beginning to do likewise. The current global spend on clinical trials is in excess of $8 billion and India has a real opportunity of taking a large slice of this pie, she informed.

India's software capabilities provide the credibility for overseas companies to outsource bioinformatics skills and capabilities from India to speed up drug discovery. Companies like Strand Genomics, Kshema technologies, Bigtec, CDC Linux, Clinigene and others have already forayed into the North American market and have started developing both partnering and contractual arrangements with US companies. It is envisaged that this market segment alone will generate revenues for Indian players to the tune of $500 million over the next 5 years.

Contract manufacturing is another business opportunity for Indian companies which provides a market size in excess of $500 million. It is estimated that the current world capacity for manufacturing plant scale biopharmaceuticals will fall way short of needs by 2005. There are approximately 300 bio-molecules in the pipeline which are envisaged to be approved over the next 3 years. Shaw informed that the present installed capacity can only meet 25 percent of the estimated need. "Indian companies can take advantage of this emerging opportunity through its ability to set up cGMP facilities both expeditiously and at a lower cost. "Indian regulatory authorities need to gear up to audit such facilities to international standards. Contract manufacturing alone."

Foreign Direct Investment in biotechnology where currently companies like Affymetrix, Sequenom, Incyte, MDS, Agilent and others have either already set up subsidiaries in India or are in agency arrangements with Indian companies. Many of these will eventually set up R&D and manufacturing facilities in the future. The growing Indian Biotech sector will fuel many more such investments.

Some of the key issues that are being perceived as detrimental to the growth of the Indian biotech sector are IP (Intellectual Property), Regulatory reform and Stem cell research.

There is an urgent need for Indian Embassies to play a part in initiating a strong credibility and visibility for Indian Biotechnology. Whilst India's biotech capabilities are gaining some recognition, there is an urgent need to amplify all efforts to build a strong image, she said. "China, has out performed India with its pro-active measures taken by the Chinese Government and strong support from the Chinese Diaspora in North America. Indian NRIs (non-resident Indians) need to emulate their Chinese counterparts."

The mission was successful in profiling India as a serious player in International Biotechnology. Companies like Biocon, Strand Genomics & Ranbaxy were profiled by several US companies for good Indo-US collaborations. Avesthagen was rated as 1 of 5 best business models at TiEcon. Sartorius & Quintiles provided outstanding examples of successful International companies operating in India. Shantha Biotechnics was also looked upon as a quality company in the vaccine segment where several companies evinced an interest in partnering with Shantha.

The mission achieved its basic objective to build visibility for the nascent Indian Biotech Sector. The interactions with regulatory and funding agencies-NIH and USFDA enabled the Indian mission to have a feel of the present regulatory scenario for biotech products to bench mark India's biotechnology framework.