The Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests has decided to consider the report of the Institutional Biosafety Committees (IBSC) on biosafety aspects involved in the manufacture of recombinant-drugs for according manufacturing clearances. The IBSC report will not be routed through the Review Committee on Genetic Material (RCGM) for opinion but will be directly considered by GEAC thereby cutting down the time taken for clearances.

Regarding the suggestion of GEAC to seek a report from RCGM on the adequacy of containment facilities and other biosafety aspects involved in manufacture of r-Pharma products, the recently held GEAC meeting decided that the committee could take its view on the basis of IBSC report without routing it through the RCGM. During the meeting various members felt that RCGM is responsible for bringing out bio-safety guidelines as well as evaluation of safety requirements in the manufacturing units even though implementation of the Protocols and Guidelines are directly under the supervision of IBSC. Ordinarily, the report of the IBSC, which has a nominee of the DBT and has the advantage of on site supervision, should be adequate, it was felt.

However, the need for a review by an impartial technical body after recommendation of IBSC, which is primarily a company outfit, was also emphasized. After deliberations, the view taken was that the report of IBSC could be considered by RCGM on a case-to-case basis and after due consideration the RCGM may make its recommendation to GEAC for a final clearance.

The Committee considered the need for a report from RCGM regarding the biosafety aspects including containment facilities for subsequent products manufactured within the same premises. On this matter the Committee's view was that after taking into consideration the type of product to be manufactured and type of containment facilities installed by the company the RCGM may make its recommendation to GEAC in every case.

The GEAC also decided that since the pre-clinical trials data are evaluated and approved by RCGM prior to DBT recommending the proposal for phase-III clinical trials, there is no need to refer the case to DBT at this stage.

The issue of delay in decision-making due to delay in obtaining opinion of experts (who were not members of GEAC) was also discussed. The Member Secretary apprised the Committee that as per prevailing practice expert opinion was sought at the initial stage of receipt of a proposal before conducting phase-III clinical trials. Noting that phase-III clinical trials are conducted to establish safety and efficacy of the product, the proposals are to be referred to outside experts along with clinical trials data at the manufacturing stage. However, this would be applicable to approved products. In the case of new products, experts' opinion will be obtained prior to phase-III clinical trials.

In the wake of the ministry's decision to hold the GEAC meeting every month, the minimum time to be given to experts for review of the proposals was decided at 30 days.