The committee headed by Centre of Science and Industrial Research director- general RA Mashelkar released the report last week and expressed confidence that if the suggestions were implemented by the government, then in a matter of five years, the country could attain investment in R&D up to Rs 1,000 crore per annum, file ten new Investigational New Drugs (IND) annually, file over 500 patents annually and export pharma R&D worth over Rs 200 crore per annum.

The report says that there is an inadequate international commitment to investment in drug discovery for infectious and parasitic diseases which are endogenous to the developing countries. India has no option but to create suitable R&D facilities in order to develop drugs to ameliorate the suffering of the people.

To encourage R&D in INDs various facilities need to be created, including animal house facilities conforming to Good Laboratory Practice, containing facilities at appropriate levels, clinical trial systems and in-vitro testing facilities.

To compete in the new Intellectual Property Rights (IPR) regime the report has suggested a higher level of IPR management coupled with strategic manufacturing and aggressive marketing. To protect the rights of the innovators, the overall Indian IPR system needs to be strengthened by involving the government, legislators, judiciary and the industry.

The report says that the patent office and its activities needs to be modernised by various means like introducing attractive fiscal incentives and mechanisms to encourage patenting of inventions overseas, creating or amending IPR laws to protect national interests while meeting the international standards, modernising the premises, information processing and assessing systems and office management and creating conditions which will attract talented qualified, trained and motivated personnel.

The committee also recommended setting up of an autonomous Drug Development Promotion Foundation to network the R&D efforts of the Indian pharma industry to derive competitive advantages from collaboration and partnership.

The functions of the foundation should include analysis of international trends in new drug development and new process development and their marketing, defining areas of relevance and value to the Indian populace and intensify the work in such areas by synergising the core competence of the constituents and enhancing the basic research component with a special emphasis on risk taking in discovery and development of new drug development systems, plant based preparations etc.

The foundation should also focus on reduction of prices of pharmaceutical products through technological and productivity innovations, generation of excellence in manufacturing practices and highest levels of quality assurance and providing international cooperation in discovery and development of new drug delivery systems and plant, mineral, animal and herbal based preparations to reduce risks, costs and development duration.

It should evolve strategies for globalisation of natural products, including plant, animal and mineral- based preparations. Recognising the importance of Indian traditional system of medicines, the committee has recommended a national policy to bring herbal and over the counter medicines under one umbrella to maintain standards of safety and efficacy and move for harmonisation and standardisation with scientific data.

It has said that a taskforce should be set up to promote production and exports of herbal medicines. As R&D in the pharmaceutical sector is cost intensive, the committee has recommended a few ways of facilitating R&D financing. The report says that venture capital funds in the area should be promoted by removing unnecessary road blocks. It has recommended creation of a R&D support fund by collecting a 1 per cent surcharge on MRP of all formulations and using the money to invest in high cost-low return area.

Finally, the committee believes that giving incentives like tax holidays and concessions will go a long way in promoting R&D investment in the pharmaceutical sector.