Export NOC exemption clarified for already-approved r-DNA products

India’s central drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has clarified that a manufacturer who wishes to export an already-approved recombinant DNA (r-DNA) product need not approach CDSCO for a Export No Objection Certificate (NOC). Previously, such a manufacturer would have had to amend its existing manufacturing license if it wanted to manufacture r-DNA product for export purposes, and as a pre-requisite to making the manufacturing license application, it would have had to approach the CDSCO for Export NOC. This particular requirement, of approaching CDSCO for export NOC prior to applying for manufacturing license, has been relaxed in cases where the r-DNA product is already approved and the manufacturer is seeking export NOC only to export same product under a different marketing name. This development is expected to expedite the timeline for manufacturers of r-DNA products to procure manufacturing license for export purposes for already approved products.