Norms eased for makers of biologic products

Source: The Economic Times, Dec 17, 2016

NEW DELHI: India’s drug regulator has eased licencing norms for vaccine and recombinant-DNA manufacturers in a move expected to promote research and development of new drugs in the country.

The Central Drugs Standard Control Organisation (CDSCO) has done away with the need for joint inspections to issue licences to allow such companies to make biologic products for testing and analysis purposes. The regulator has also clarified that these biologics can also be exported only for the purpose of examination, test or analysis and not for commercial purposes in a circular dated December 13.

According to CDSCO’s latest decision, State Licencing Authorities will issue ‘Form 29’ licences to vaccine and r-DNA makers within three working days of them submitting their application. The joint inspection of these applicants will now be carried out using a risk-based approach only after the licence is issued.

Form 29 licences are issued to allow companies to manufacture biological products for examination, testing or analytical purposes.

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