In this GATT era, Indian drugs and pharmaceutical scientists have belatedly begun to focus on drug, rather than on process, development
IN A significant shift in research emphasis, Indian scientists in the drugs and pharmaceuticals sector are focusing on product development rather than the usual process development. The government has launched a "Drug Mission" designed to involve industry in drug development from the very beginning.
"We are equipping ourselves for the age of GATT in which only the product patent holder will profit," says an official in the department of science and technology (DST), the agency coordinating the Mission. The Mission will be used to create state-of-art technologies for aspects such as drug screening and artificial simulation of disease conditions.
New drugs specific to Indian therapeutic uses will be developed by collaborations between the pharmaceutical industry, universities and government scientific research institutions, say scientists in the technology utilisation division of the Council of Scientific and Industrial Research (CSIR), a nodal agency in the Drug Mission.
While the government has invested seed money of Rs 10 crore for 1994-95, industry and financial institutions are expected to make their own additions the Mission's funds.
At its first meeting held on August 1, in which representatives from 22 leading drug manufacturers participated, the Mission set up a national expert committee chaired by M M Sharma, leading chemical researcher in the University Department of Chemical Engineering, University of Bombay. The committee is to examine the industry's proposals for collaborative R&D and monitor the Mission's progress.
Participating companies and institutes have been asked to prioritise their R&D support to various drug categories of disease or therapeutic activity, such as antibiotics, cardiovascular and antiviral drugs, diagnostics and oral contraceptives.
"Based on the response, an 'attractiveness versus feasibility' chart will be plotted, which will help to determine our priority area of support in the programme for drug development in various disease groups," says a CSIR scientist.
Although government officials are optimistic that the newly launched Drug Mission will help to speed up the process of drug development, which at present takes 13-15 years and about Rs 1,500 crores per drug, a Torrent Pharmaceuticals representative says cautiously, "It is yet to be seen how committed the government is."
J M Khanna, executive vice-president of Ranbaxy, which spends 5 per cent of its sales turnover mainly on applied research R&D, says, "We could work in partnership with the government for product development. However, the industry must have management control." Ranbaxy has submitted a proposal to the Drug Mission for a project for new drug discoveries in the field of antibiotics, with an initial investment of Rs 50 crores and recurring investment of Rs 10-15 crores, to be shared equitably with the government.
But, says Khanna, "The new drug policy gives us no incentives for research", pointing out that the pharmaceutical industry has been asking for exemption from heavy customs duties on chemicals, raw materials and instruments, and for tax benefits on R&D. The new drug policy states that at least 1 per cent of the drug industry's annual turnover of Rs 6,000-7,000 crores should be used for R&D. But, Khanna counters, "An investment of Rs 60-70 crores is too little."
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