SUGAM registration Mandatory: CDSCO directs State drugs controllers to enforce rule
New Delhi: Through a recent notice, Central Drugs Standard Control Organization informed all drug controllers about online SUGAM registration becoming compulsory for various licences granted for manufacture for sale or distribution of drugs, directing them to take necessary action in this regard
This follows the recent amendment that was made by the Ministry of Health and Family Welfare to the Drugs and Cosmetics Rules, 1945 by inserting Rule 84AB - Information to be uploaded by the licensee on online portal SUGAM.
As per the inserted rule, all 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 and the information so provided shall be updated from time to time and such information uploaded by the licensee shall be verified by the concerned Licensing Authority.
With its release in the gazette notification, the rule is not effective from January 10 2019.
The CDSCO has directed all the State Drugs Controllers to take necessary action and direct all the manufacturers to upload the data on SUGAM portal regarding the subject. The move will strengthen the drug regulatory system by way of improving the transparency, accountability as well as accessibility of the drugs in the country, the direction added
Further, the state drug controllers have also been directed to verify the data uploaded by the manufacturers for compliance of the provisions of the rules. In case of any technical issues, one may email to firstname.lastname@example.org or contact IT cell at CDSCO headquarter, the notice added.
In this regard, CDSCO has recently launched a module under SUGAM portal for uploading the data for this purpose. in this regard, CDSCO has also developed a user Manual (https://cdscoonline.gov.in/CDSCO/resources/app srv/cdsco/global/helpfiles/Manufacturer sign up.pdf ) which will provide the applicant with a step by step procedure for uploading the data.
The e-governance solution, SUGAM was launched in the year 2015. This online portal 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.