The Task Force on Recombinant Pharma sector under the Chairmanship of Dr R A Mashelkar, DG, CSIR has recommended the constitution of 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 final report of the task force submitted to the union minister for environment & forests, A Raja, here on September 13 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 (Living Modified Organisms) from environmental angle. Evaluation of the product safety, efficacy, clinical trials, market authorization and post market surveillance is the mandate of the DCGI; The product where the end product is a LMO has the potential for propagating/replicating in the environment and therefore needs a higher level of regulation as compared to products derived from LMOs where the end product is not a LMO. Further, the magnitude and probability of environmental risk depends on the extent of use of LMOs within the R&D and production units. In case of imports, this risk is not there especially in cases of import of therapeutic proteins in finished form, task force has noted.

Taking into consideration the regulatory objective of RCGM (Review Committee on Genetic Manipulations), 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 has 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 a LMO, indigenous product development, manufacture and marketing of pharmaceutical products where the end product is a 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 a LMO.

The indigenous product development, manufacture and marketing of pharmaceutical products derived from LMOs but the end product is not a LMO category has been further divided into two parts namely (i) organisms falling under Risk Group I & II and (ii) Risk Group III and above. Approval of GEAC is required only for organism falling under Risk Group –III & IV. No approval of GEAC is required for Phase- III clinical trials under this category. DCGI has to approve clinical trials based on the recommendation of RCGM and product approval based on the results of the clinical studies.

In the second case, since the end product is an LMO, the probability of risk due to accidental release is higher and therefore GEAC will be responsible to evaluate the environmental impact caused by handling and large-scale use/release of LMOs. Accordingly, GEAC should consider and approve phase III human clinical trials. The GEAC should approve environmental release based on the environmental risks vs. benefits analysis, which takes into consideration the recommendation of RCGM and results of the clinical trials. DCGI should examine the data on the toxicity, allergenicity and QC tests and recommendation of RCGM before approving human clinical trials.  The DCGI should also take into consideration the views of GEAC on the safety of the product for conduct of human clinical trials from environmental angle. DCGI should be responsible for evaluation of product efficacy and safety based on the data generated during human clinical studies prior to market authorization.

Since the third category import and marketing of LMOs as Drugs/Pharmaceuticals in finished formulations pertains to import of LMOs, the only activity envisaged within the country prior to issue of market authorization is the conduct of human clinical trials and therefore the approval of GEAC for conduct of Phase –III clinical trials would be applicable, task force has observed.

Import and marketing of LMOs as Drugs/Pharmaceuticals in bulk for making finished formulation involves setting up of facilities for formulations and conduct of clinical trials within the country before market authorization. The end product being an LMO approval of RGCM, GEAC and DCGI as outlined for second category would be applicable. Approval of GEAC is not required for the category of import and marketing of products derived from LMOs as Drugs/Pharmaceuticals in bulk and/or finished formulations where the end product is not a LMO. This scenario in terms of environmental risk falls under the least risk category since there is no exposure to LMOs within the country. Therefore approval under Rules 1989 of EPA would not be required. To streamline the regulatory process in the r-Pharma Sector, the Ministry of Environment & Forests had constituted a task force 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 LMOs in the pharmaceutical industry during the 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. The review and recommendations of the Task Force are based on a consultative approach involving a large number of stakeholders spanning diverse interests.   The draft final report was posted on the MoEF website for a period of 6 weeks for further stakeholder consultation.  Based on the recommendations and comments received, the report was adopted by the members of the Task Force on 13th June 2005.