The Genetic Engineering Approval Committee (GEAC) has listed out 20 pending pharma applications as on August 30. The committee is to consider three of these applications in its next meeting Scheduled in October. These pertain to grant of permission to manufacture and market of Filgrastim Injections by Ranbaxy, permission to import Zolair (omalizumab) humanized anti –IgE anti body (murine monoclonal antibody) by Novratis and permission to conduct phase III clinical trials for indigenously developed Virkinase –recombinant Streptokinase by Virchow Biotech Hyderabad.
The other pending applications are for clearance to import and market recombinant Bovine Somatropin (L.G. Chemicals Pvt. Ltd), import and market r-human DNA Hepatitis B Vaccine Hexavac. (Aventis Pasteur India Ltd.), import of r-hu-Epidermal Growth factor for manufacturing in India a fixed dose combination of 10 ug/GM and Silver Suphdiazin 1% as a Cream for Topical in burn cases from GGE and Biotechnology Cuba (Glenmark Laboratories Pvt. Ltd.), import and market finished product in India r-Human G-CSF, 300mcg in pre-filled syringes (Clarisis Life sciences Ltd. Ahmedabad), import and market r-human Insulin Glulisine APIDRA (Aventis Pharma Ltd. Mumbai) import of r-Leisg-111 F (Institute of Medical Sciences, BHU, Varanasi), import and market r-human Granulocyte Macrophage Colony stimulating factor in (GM – CSF) (Emcure Biotech Ltd. Pune), manufacture and market r-insulin supplied by Biocon (Cadilla Pharmaceuticals Ahmedabad) manufacture and market r- human Interferon alpha 2b r-DNA origin (Wockhardt Ltd. Mumbai), manufacture hepatitis C Viral antigens for commercialization by ( Sudershan Biotech Ltd), manufacture and market formulation of Recombinant-human-insulin of 3 types, soluble insulin, insulin Isophane, 30:70 combination of soluble insulin + Isophane insulin in India-Bulk Insulin crystals, revalidation permission for manufacturing and marketing rhuman Granulocyte Colony stimulating factor (G-CSF) (Dr. Reddy's Lab. Ltd), import EGF-R Neutilising monoclonal antibodies hr3 Thera CIM from Centre of Molecular Immunology, Cuba (Biocon), manufacture and market human insulin from Biocon Ltd (Ranbaxy), permission for bioequivalence study of human insulin (r-DNA) origin formulations prepared using approved (Biocons) human insulin (r-DNA) origin (Cipla Ltd.) and permission for import of Actilyse (recombinant human tissue type plasminogen activator) 50 mg for ExTRACT study from Germany (Sanofi Aventis).