Express Pharma

Post Feb 1, r-DNA derived drug applications to be accepted only online

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Jan 15 CDSCO notice pertains to clinical trials, marketing authorisations, registration certificates and import licenses

In a notice dated January 15, Dr G N Singh, Drugs Controller General (India) has informed all manufacturers, importers and CROs of r-DNA derived drugs that filing of applications for such drugs will be accepted only via the online portal SUGAM from February 1.

This decision was taken post a stakeholders meeting held on January 10. No offline applications for r-DNA derived drugs will be accepted post February 1.

This move continues the Central Drugs Standard Control Organization’s commitment to implement its e-governance initiative via SUGAM, which was launched on November 14, 2015.

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