India Pledges to Issue Export Licenses for r-DNA Therapies, Vaccines Within 10 Days

India’s Central Drug Standard Control Organization has developed a new system for granting export certifications for recombinant DNA therapies and vaccines that promises sponsors a clearance within 10 days if they submit five documents.

Sponsors must submit a cover letter, purchase order, manufacturing license, a pro-forma invoice and a registration certificate.

If sponsors provide the agency with adequate documentation and support for the application, CDSCO will issue a no objection certification (NOC) to clear the exports in 10 days, according to the county’s Drug Controller General.