The Genetic Engineering Approval Committee (GEAC) has cleared the application of Nicholos Piramal to import and market Avonex (Interferon beta-1a) of Biogen B. V., Netherlands in the country. However, the company will have to carryout a post marketing surveillance (PMS) programme for the first two years and submit the report to the concerned authorities.
The Committee has also decided not to insist upon phase III clinical trails for the drugs after the recommendations from the Department of Biotechnology (DBT) and Central Drugs Research Institute (CDRI). The DBT had preferred PMS, instead of phase III clinical trials in this particular case.
Avonex is known to have received US FDA, European Commission and EMEA approval in 2003. It has been approved for marketing in Netherlands, Austria, Denmark, France, Germany, UK, USA, Brazil etc.
GEAC also requested DCGI to forward the PMS reports received by the Directorate for information of the GEAC in all the cases in future. The recent meeting of the committee also considered the application of Indian Immunologicals Limited for permission to conduct phase III clinical trials of combined Rabies DNA Vaccine (veterinary use). The Committee approved the request for conduct of phase III clinical trials subjected to the condition that studies on integration of plasmid DNA in the germ line tissue be assessed in larger population of larger animals. The plea of Bharat Biotech International Ltd for permission for manufacture and marketing of r-human Epidermal growth factor was, however, deferred.
The committee also took up the case of Wockhardt Ltd for permission to conduct phase III clinical trials on r-h GCSF. After going through the comments made by RCGM, DCGI and IMTech on the application, it was decided that the recommendation of RCGM on the adequacy of the pre-clinical trials and safety of the product based on the pre-clinical data would be made available to the GEAC for taking a final view. RCGM would now have to comment on the safety of the product on the basis of evaluation of the pre-clinical data on toxicology and allergenicity, adequacy of the information on the analysis of the product in terms of impurity profile and adequacy of the containment facilities. Based on the comments received from RCGM and after receiving additional information required, the Committee authorized the chairman of GEAC to take a final decision.