The Genetic Engineering Approval Committee (GEAC) under the ministry of environment and forests has decided to give clearance for phase III clinical trials of recombinant drugs only after making sure that the clinical trial applications have got approvals first from the office of the Drugs Controller General of India. The committee, which met here recently, said that the decision was meant to avoid a situation of conflict.
The clearance for phase-III clinical trials under1989 Rules would be issued only after the proposals have been recommended by RDAC, the committee said. It has also requested the DCGI to forward the minutes of the RDAC meeting to the member secretary in all such cases in future. The meeting however, permitted Virchow Biotech Pvt Ltd, Hyderabad to conduct Human clinical trials on r-h Interferon Alpha 2b (INFERON) subject to clearance from the office of DCGI.
The committee accorded approval for manufacturing finished dosages form imported crystals of r-human Insulin to Shreya Life Sciences Pvt. Ltd, Mumbai. Permission was also given for the import pf 1500 vials of Monoclonal antibody hR3 (thera CIM manufactured by r-DNA technology by Biocon Biopharmaceuticals Pvt. Ltd. Bangalore) from Centre of Molecular Immunology, Havana city, Cuba.
However, it has asked Indian Immunolgicals Limited Hyderabad not to initiate clinical trials of its indigenously developed combined Rabies DNA Vaccine (Veterinary use) unless it provides detailed information on the association of DNA with germ-line of recipients to DBT and get their positive comments. The company now will have to submit a clarification from DCGI on the status of approval for conduct of phase-III clinical trials for the combined rabies DNA vaccine for veterinary use. The company would also have to submit the information as per the GEAC proforma. The case of ex-post facto approval for conducting phase III clinical trials and permission for manufacture and marketing of rh -PDGF-BB (Healace 0.01%) by M/s Virchow Biotech Pvt. Ltd. Hyderabad is to be reconsidered during the next meeting.