The Indian Pharmaceutical industry has the potential to reach US$ 48 billion by the 2007 and enhance its role in the global market sphere, predicts a Confederation of Indian Industry (CII) study. The study has recommended greater incentives for investments in R&D, higher EXIM Bank allocation, public-private partnerships, and increasing of budget allocations and spends for research.

The CII feels that the ‘Global India Pharma Inc', India could stamp its authority by exporting domestically produced generics, and presenting itself as an off-shoring location for R&D. According to the paper, the key to growth would be to intensify domestic competition among local players, sustaining growth and profitability, and evolving global landscape.

The study further states that India could also offer itself as an off-shoring location for manufacturing and other support services, which could well propel Indian pharma industry into the position of a world leader.

The CII study has, however, indicated that it would be imperative to leverage emerging opportunities and meeting the key challenges, to establish itself as a global leader. The study states that the transition from a strong global position to being a true global leader would depend much on the ability to withstand shocks and consistently delivering profitable growth. It would also be important to focus on operational excellence, the study observes.

According to the study, India could evolve a global landscape by consolidating and creating large global generic players. The study points out that top 10 generic players constitute 27 per cent of the global market.

The study has also called for special focus on R& D on chronic diseases and lifestyle drugs. In India, research spending on life threatening disease is abysmally low, and it has to increase if India has to position itself as a global leader in the pharma sector.

For clinical trials, the CII study states that it would be imperative to improve the regulatory approval process and increase public awareness and transparency. The study has also suggested ensuring ICH compliance to existing ethics committees, and the need for creating ethics committees (ICH-GCP compliant) for private hospitals. In order to encourage further investment in contract manufacturing facilities the study has recommended providing incentives like special zones or registration of global sourcing units for extended tax holidays and other incentives.

It has also suggested soft loans for world class manufacturing facilities and soft loans for modernisation (meeting schedule M) and for encouraging consolidation of small players in addition to tax holiday period.

However, there are certain challenges like long gestation period, ranging from three to five years, which leads to delay in alliances and collaborations. The paper also states that operating bottlenecks from infrastructure and related issues cause concern to industry, which the Government should address, in order to make Indian pharma sector a truly global player.