NOC for manufacture of unapproved/approved new drugs/banned drugs (solely for export) to be obtained from Zonal offices via Sugam Portal, effective from 15th May 2024: CDSCO

The Central Drugs Control Standards Organization (CDSCO) has communicated to drug controllers of all States and Union Territories regarding the withdrawal of powers delegated to them to grant NOCs effective from 15th May, 2024. In light of this, pharmaceutical companies will be required to procure their NOCs from zonal offices of the CDSCO via the Sugam portal (online) prior to obtaining licenses from the State Licensing Authorities for the manufacturing of unapproved/approved new drugs or banned drugs for export purposes.

Further, all State / Union Territory Drug Controllers have been instructed to hand over all NOCs issued from 20th August 2018 to 14th May 2024 to the respective Zonal Offices of CDSCO.

Background:

With a view to facilitate ease of doing business, CDSCO, through a Circular dated 2nd August 2018, delegated with the approval of the Ministry of Health & Family Welfare, the power to grant NOCs for the aforementioned purpose to the State Licensing Authorities.

Source: Central Drugs Control Standards Organization