The Genetic Engineering Approval Committee (GEAC) has accorded permission for revalidation of GEAC approval for import and marketing of human Insulin (DNA origin) and its formulations by Novo Nordisk in its recent meeting.

The Committee noted that the GEAC in its 33rd meeting held on July 5, 2002 had approved import and marketing of human Insulin (DNA origin) and its formulations by the company for a period of four years. In accordance with the provisions of Rule 13(2) of the 1989 Rules, the GEAC gave 'No Objection' for revalidation of GEAC permission for two more years.

The Committee also considered the need for continued renewal of GEAC permission for r-Pharma proposals in light of the recommendations of the Task Force on r-Pharma, which has been adopted by the GEAC. The Committee is also of the view that renewal of GEAC permission is not necessary in respect of those r-Pharma proposals, which do not require the approval of GEAC as per the new procedure.

GEAC also gave permission for revalidation of GEAC approval for import and marketing of Drotrecogin alpha (activated) - Xigris and Humatrope (Somatropin) - DNA origin by Eli Lilly and Company (India), for two more years.

The Committee noted that the GEAC in its 33rd Meeting held on July 5, 2002 had approved import and marketing of Drotrecogin alpha (activated) - Xigris for a period of four years. As per Rule 13(2) of the 1989 Rules, approvals of GEAC are valid for a period of four years at the first juncture and renewable for two years at a time.

It also noted that the GEAC had approved the import and marketing of Somatropin Injection (r-DNA) for a period of four years in its 13th meeting held on November 14, 1996. Subsequently in accordance with the provisions of Rule 13(2) of the 1989 Rules, the approval was revalidated for a period of two years in the years 2000, 2002 and 2004.