The Genetic Engineering Approval Committee (GEAC) has accorded permission to conduct phase III clinical trials on r-human interferon alpha to Cadilla Healthcare. The approval was based on the recommendation made by RCGM and the observations made by the representative of DCGI. The approval is subject to clearance from the DCGI.
The GEAC also considered an application for Ex post facto approval for conducting phase III clinical trials and permission for manufacture and marketing of rh -PDGF-BB (Healace 0.01%) by Virchow Biotech Pvt. Ltd. Hyderabad. However, a decision on the matter was not taken as the committee wanted the recommendation of RCGM regarding the bio-safety aspects including the adequacy of the containment facilities before taking a final view.
Regarding an application from Shreya Life Sciences Pvt Ltd, Mumbai for permission to manufacture finished dosages from imported crystals of r-human Insulin from M/s Bioton Co. Ltd. Poland by the GEAC observed that present proposal is for import of bulk recombinant crystals of r-human Insulin from Bioton Co. Ltd. Poland from an approved source and manufacture of finished dosages form of recombinant human Insulin in the manufacturing facility located at Aurangabad. The Committee took a view that once information about the USP grade of the recombinant human insulin crystals to be imported is certified by the manufacturer as well as the company, the proposal may be placed before the Committee for consideration.
In the case of Biocon's plea for permission for import to conduct Phase II clinical trials in Indian cancer patients of Monoclonal antibody hR3 (thera CIM) manufactured by r-DNA technology from Center of Molecular Immunology, Havana city, Cuba, GEAC called for the submission of complete dossier before any decision. After detailed deliberations, the Committee was of the opinion that such type of product is highly desirable to be produced in the country for the benefit of the cancer patients. However, the in-process quality control should be kept at utmost priority for the safety of the patients.
"Since this would be the first experience of a monoclonal product to be tried in human subjects suffering with cancer, the complete information with proof on the in-process quality control of the humanized monoclonal antibodies should be in place. The applicants may therefore be asked to submit the complete dossier for further consideration by the Committee," GEAC noted.
The recent meeting also took up reconsideration cases for permission for import and marketing of r-human Hepatitis B vaccine a component of Hexavalent vaccine (Hexavac) by Aventis Pasteur India Ltd. New Delhi and permission to manufacture fixed dose combination of silver sulphadiazine and rhu- epidermal growth factor (EGF) as a tropical cream by Glenmark Pharmaceuticals Pvt. Ltd. Mumbai. In both the cases, the committee decided to take a final decision after receiving views from the DCGI.