The Genetic Engineering Approval Committee (GEAC) under the Ministry of Environment and Forests has requested the office of the Drugs Controller General of India (DCGI) to check for prior GEAC approval while renewing the import license of recombinant drugs and vaccines.
The GEAC has suggested that the DCGI should issue necessary directions if the applicant has not gone through the clearance process. The committee also felt that necessary amendments under Rules could be considered for the purpose.
The GEAC observation has come after it decided to accord ex-post facto approval for import and marketing of r-human growth hormone (somatropin) formulations by Novo-Nordisk India from Novo-Nordisk, Denmark. The application of the company was held up with GEAC after the committee had noted that the company had failed to secure prior GEAC approval before approaching DCGI.
The recent meeting of GEAC considered the explanation submitted by the company and concluded that it was essentially a procedural lapse. This was a problem of "regulation since the company had not been directed to obtain the approval of GEAC while renewing the import license," it noted.
The meeting held on June 9th also cleared Zydus Cadila's application to import and market Betaferon (interferon beta-1b) 0.25 mg from Germany. The permission was accorded after the committee noted that the drug had successfully undergone phase-III studies of 2 years duration both in US and Canada. The product was tested on about 338 patients in total during the clinical trials. The product was declared to be safe/effective in those studies, it observed. GEAC also decided against generation of PMS data as the product had been approved for marketing in about 80 countries.
The decision on Biocon India's application to permit the manufacture and marketing of insulin was deferred by the committee and the request of Glenmark Laboratories Pvt Ltd to waiver the phase III clinical trial requirements for the import of r-Human Interlukin-2 (rhuIL-2) from Argentina, was not entertained. GEAC also rejected a similar request from V H Bhagat Co, Mumbai to avoid the clinical trial obligation for the permission for import and marketing of r-human Erythropoietin (rhEPO) manufactured by Shenzhen SPEC- Bio- Pharmaceuticals Industry Co. Ltd, China.