CDSCO issues Guideline for Uploading Data of drug manufacturing facilities and approved drug formula on SUGAM portal

Dec 07, 2018 | by Avantis RegTech Legal Research Team

The Central Drugs Standard Control Organisation (COSCO) has launched a module under SUGAM portal for uploading the data at  pertaining to licensed drug manufacturing facilities and approved /licensed drug formulations for having up to date information of drugs manufactured in the country. All drug manufacturers were also requested to upload the aforesaid data on the SUGAM portal on priority. In this context it is also pertinent to mention here that the draft Rules have been published vide G.S.R No. 609(1), dated July 11, 2018 by the Ministry of Health and Family Welfare to amend the Drugs and Cosmetics Rules providing that the licensees licensed to manufacture drugs for sale or distribution shall register with portal SUGAM ( and upload information as per the format provided in the portal pertaining to the licenses granted for manufacture for sale or distribution of drugs and it shall be updated from time to time. Comments / suggestions received on draft rules are under consideration by the Ministry.

In this regard, COSCO has developed and uploaded on November 29, 2018, an User Manual which will provide applicant a step by step procedure for uploading the data (copy of the user manual is enclosed in the notice.)

All the Industry/Pharma Associations are requested to circulate the said User Manual among its members and give wider publicity for uploading the data on the SUGAM PORTAL which will strengthen the drug regulatory system by way of improving the transparency, accountability as well as accessibility of the drug in the country.





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