The Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests has decided to meet every month at a prefixed date so as to speed up and streamline the regulatory clearances that are accorded by the committee. The uncertainty in GEAC meetings and subsequent clearances has been a cause for major concern for Indian biotech industry that was looking for importing/producing genetically modified therapeutic products in the country.

The committee that met under the chairmanship of Veena Chhotray, additional secretary, on February 3, 2004 decided to hold GEAC meetings on the second Wednesday of every month. In the eventuality of the fixed date being a Gazette holiday, the meeting would be held on the successive working day.

The GEAC informed that the decision was in view to streamline the regulatory process considering the needs and concerns of the pharma sector. Chhotray emphasized that the GEAC was entrusted with the highly sensitive and delicate responsibility of harmonizing the demands for scientific and technological progress in the fields of agriculture and pharmaceuticals and the environmental concerns associated with these processes. The responsibilities become all the more onerous because biotechnology is still an evolving field. The committee has also taken note of the mandate of the Task Force on Agriculture Biotechnology under the chairmanship of Prof MS Swaminathan and the presentation made by secretary (E&F) to the Task Force and informed that the committee has initiated efforts to rationalize various policy issues at the ministry level.

The meeting accorded environmental clearance for import of r- human Lactoferrin (rhlf) Placebo for clinical studies by Reliance Clinical Services, Mumbai from M/s Agennix Inc. Houston, USA in the field of oncology as an anti-tumour drug along with standard Paclitaxel/Carboplatin in non-small cell lung cancer. It also revalidated the permission to manufacture and market human insulin by MJ Pharmaceuticals, Mumbai.

GEAC approved the import and marketing of Ovidrel-250 mcg (Recombinant Human Chorionic Gonadotropin/Chorionogonadtopin Alfa) from M/S Industria Farmaceutica Serono SPA, Italy by Serum International Ltd., Pune.

Approval was also accorded to import of insulin detemir (r-DNA origin) for formulation for Phase-III clinical trials from Novo Nordisk A/S Denmark, by Novo Nordisk Pvt Ltd., Bangalore for treatment of diabetes.

As regards the proposal for import and marketing of Recombinant Bovine Samatrotropin from LG Chemicals, Korea by LG Chemicals Pvt. Ltd. New Delhi, the committee took note of the policy of the Dept. of Animal Husbandry and Dairying not to permit the import of milk and milk products derived from animals subjected to the exposure of Bovine growth Hormones (BGH) / Bovine Somatotropin Hormones (BST)/estrogenic substances. It was therefore decided that it would not be appropriate for the GEAC to take any decision that would be divergent from the general policy followed by the Animal Husbandry Department in the case. The Animal Husbandry Department was requested to deliberate upon this issue and give a considered view.

The proposal for import and marketing of Recombinant Human Growth Hormone (JINTROPIN) manufactured by Changchun Gene Science Pharmaceuticals Co. Ltd. people of China by Hindustan Bio-Sciences Ltd. Hyderabad was rejected by GEAC for non submission of requisite information sought by DBT even after repeated reminders. It is claimed that JINTROPIN stimulates linear growth and increases growth rate in children who lack endogenous growth hormone. In adults, it is believed to help in reducing fat mass, increasing muscle mass and improving energy.