Make drugmakers upload data in SUGAM portal: CDSCO Committee recommends State Drug Authorities
New Delhi: The Drugs Consultative Committee (DCC), functional under Central Drugs Standard Control Organisation (CDSCO), recently recommended the State Drug Control Authorities for issuing orders under Drugs and Cosmetics Rules, and direct drugmakers to mandatorily upload data pertinent to the licenses granted for manufacture, sale and distribution of drugs in the online portal- SUGAM.
SUGAM portal provides a single-window for all its stakeholders to access the services provided by the portal by implementing role-based access control and actions. It has consolidated the entire Drug Regulatory framework at the centre and provides a centralized dashboard for monitoring the various regulatory clearances all over the country.
SUGAM enables online submission of applications requesting for permissions related to drugs, clinical trials, ethics committee, medical devices, vaccines and cosmetics. The system also builds up the database of approved drugs, manufacturers & formulations, retailers & wholesalers in India. The project also enables the complete digitization of the old CDSCO records having primarily application within the File, noting in Green sheet, and supporting documents.
Central Government has amended the Drugs and Cosmetics Rules, 1945 incorporating Rule 84AB making online submission of data through SUGAM portal as a mandatory requirement under D&C Rules.
As per the notification, the licensee shall register with portal SUGAM (www.cdscoonline.gov.in) and upload information, as per the format provided in the said portal pertaining to the licences granted for manufacture for sale or distribution of drugs.
The information so provided shall be updated from time to time by the licensee and this information is required to be verified by the concerned State Licensing Authority for confirmation. CDSCO already issued a letter to all State Drugs Controllers requesting them to verify the data and approve them at the earliest.
DCC in its meeting deliberated and recommended that all State Drug Controllers should ensure that uploading of required data as mandated under Rule 84AB is completed by 30.06.2019.
DCC therefore, recommended that all the State Drugs Control Authorities should ensure uploading of the required data by manufacturers within 15 days by issuing orders under Drugs and Cosmetics Rules.