To streamline the regulatory process in the r-Pharma Sector, the Ministry of Environment & Forests had constituted a task force under the chairmanship of Dr R A Mashelkar, DG, Council of Scientific and Industrial Research (CSIR) last year. The mandate of the task force was to review the current framework and recommend a transparent and streamlined regulatory mechanism and process for the use of Living Modified Organisms (LMOs) in the pharmaceutical industry during various stages of R&D, testing, manufacture and import of LMOs as drugs. The task force held five meetings during the period April 2004 to June 2005 and had wide ranging consultations involving a large number of stakeholders spanning diverse interests. The final report has come now, and it calls for a Standing Technical Advisory Committee on Biotechnology Regulation under the chairmanship of an eminent scientist to redress and look into various regulatory aspects and make issue-based recommendations on case-by-case basis prior to any deviation from the regulatory mechanism. The report concluded that the regulatory objective of Genetic Engineering Approval Committee (GEAC) should be confined to regulation of proposals, which involve large-scale use of LMOs from environmental angle. It emphasized that the DCGI has to play an important role in the evaluation of the product safety, efficacy, clinical trials, market authorization and post market surveillance of r-DNA drugs. Taking into consideration the regulatory objective of the Review Committee on Genetic Manipulations (RCGM), GEAC and DCGI and the risks involved in the use of LMOs during the research & product development, manufacture and import from the environmental angle, the task force rationalized the regulatory procedure for five categories viz, indigenous product development, manufacture and marketing of pharmaceutical products derived from LMOs but the end product is not an LMO, indigenous product development, manufacture and marketing of pharmaceutical products where the end product is an LMO, import and marketing of LMOs as Drugs/Pharmaceuticals in finished formulations, import and marketing of LMOs as Drugs/Pharmaceuticals in bulk for making finished formulation and import and marketing of products derived from LMOs as Drugs/Pharmaceuticals in bulk and/or finished formulations where the end product is not an LMO.
Specific comments were given on each of these categories to ensure clarity in the regulatory procedures in future. Now the ball is in the government's court. The implementation of the recommendations of the task force is the need of the hour. As experts themselves have opined, most of these changes can be effected without any legislative amendments. Just procedural changes, put in place through departmental circulars should do the trick. The central government should also ensure that its departments, especially the office of the DCGI, are geared up to take up the added responsibilities. The Advisory Panel should also be in place without delay and GEAC should confine its operations to what has been suggested by the Mashelkar Panel. The faster the changes, the better will be the future of Indian biotech industry.