New Delhi: Through a public notice released on 29.11.2018 Central Drugs Standard Control Organisation(CDSCO) has announced the launch of a User Manual which will provide the applicant with a step by step procedure for uploading the data of drug manufacturing facilities and approved drug formulations on the module under SUGAM portal.
CDSCO has launched a module under SUGAM portal for uploading the data at www.cdscoonline.gov.in pertaining to the licensed drug manufacturing facilities and approved/licensed drug formulation 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. 629(E), dated 11.07.2018 by the Ministry of Health and Family Welfare, Govt of India to amend the Drugs & Cosmetics Rules providing that the licensees licensed to manufacture drugs for sale or distribution shall register with portal SUGAM (www.cdscoonline.gov.in) 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, CDSCO has developed a User Manual which will provide the applicant with a step by step procedure for uploading the data.
The notice requested All the Industry/ Pharma Associations 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.