A wide range of opportunities

Although biotech is beginning to make a splash in India, there remain a limited number of companies with branded biologics in the works. To Prashant Tewari, Managing Director of USV, his company is indeed one of the few that have biotechnology patents. "We believe that in the area of biosimilars, intellectual property will be critical for penetrating regulated markets," he says. USV's biosimilar projects are focused on the regulated markets. They have therefore been designed bearing in mind intellectual property issues. "At this moment, we are undergoing a transition process that will take us from generics development into biotechnology," Tewari says. "In terms of technology issues, biotechnology is a much more complex area. After seven years of hard work, we have been able to develop this technology in-house. This effort has paid off. At the moment, we have three biosimilar products going into full scale manufacturing."

USV's next step will be to use these same capabilities and all that has been learned from this process to move into innovation. The project it is working on is called pegylation. Protein half-life in the body could thus be extended through pegylation. "I think that all together, we still only dedicate 10 percent of our work to this area," notes Tewari. "However, this will increase as we become more competitive in these capabilities. The proportion of our R&D investment will also increase in this field. Today it is 90:10, but it will become something like 75:25." Most of the technology related to biotechnology has been developed in-house, a difficult task: "As we start transforming USV into an innovator I think technology will be our biggest challenges," concludes Tewari.

Two years ago, Wockhardt inaugurated its biotech park to create a manufacturing base for the worldwide requirements. "Thanks to our biotech park, we have been able to start exporting to some South American, CIS and South East Asian countries," says Khorakiwala.

Lastly, Wockhardt has been doing research on new chemical entities, mainly on anti-infectives, working in different areas and hoping everything goes as expected. "In the medium term, biotechnology will translate into considerable growth for Wockhardt," says Khorakiwala. "New drug discoveries will take more time."

CRAMS: The Gateway to Indian Success

Vimal Kumar, joint MD, Shasun.

The Indian pharmaceutical industry is betting big on the growing opportunity in the CRAMS segment. With international competition heightening, pharmaceutical companies worldwide are seeking to reduce production and research costs. Indian companies, with their strong chemical engineering capabilities and low costs, offer these advantages. According to analysts, global pharmaceutical manufacturing was estimated to be at $50 billion in 2004, out of which 30 percent was outsourced. This, along with the contract research segment estimated at about $6 to 10 billion, makes CRAMS a very lucrative opportunity. Also, what makes the case strong for future growth is the fact that the number of players focusing on this opportunity is still small. India has the potential to garner at least 35 to–40 percent global market share in this segment. With foreign companies increasingly leaning towards India, the chances of big growth in the future looks bright.