**Summary:**
The Central Drugs Standard Control Organization (CDSCO), under the Ministry of Health and Family Welfare, Government of India, issued a notice (CDSCO IT 2018 22, dated BA I 208) regarding the mandatory uploading of data pertaining to licensed drug manufacturing facilities and approved drug formulations onto the SUGAM portal (www.cdscoonline.gov.in). This initiative aims to create an up-to-date database of drugs manufactured in the country, enhancing transparency, accountability, and accessibility within the drug regulatory system.
The notice references draft rules published vide G.S.R No. 629E, dated 11.07.2018, which propose amendments to the Drugs & Cosmetics Rules, mandating licensees to register on the SUGAM portal and upload required information, updating it periodically. A User Manual has been developed by CDSCO to guide applicants through the data uploading process. Pharma Industry Associations are requested to disseminate the User Manual and promote data uploading on the SUGAM portal. The Drugs Controller General of India, Dr. S. Eswara Reddy, issued the notice.
Key Entities Referenced
CDSCO: Central Drugs Standard Control Organization, the national regulatory body for pharmaceuticals and medical devices in India.
SUGAM Portal: An online portal (www.cdscoonline.gov.in) launched by CDSCO for uploading data related to drug manufacturing facilities and approved drug formulations.
Drugs and Cosmetics Rules: The legal framework governing the regulation of drugs and cosmetics in India, being amended to mandate registration and data upload on the SUGAM portal.
Ministry of Health and Family Welfare: The government ministry responsible for health policy in India, which published the draft rules to amend the Drugs and Cosmetics Rules.
New Delhi: Location of FDA Bhawan, the office of Central Drugs Standard Control Organization in India
Dr. S. Eswara Reddy: Drugs Controller General of India
Industry Pharma Associations: Groups representing pharmaceutical manufacturers, requested to circulate the User Manual for the SUGAM portal.
G.S.R No. 629E: A notification number related to the publication of draft rules amending the Drugs and Cosmetics Rules.
CDSCO / IT / 2018 - (22)
Government of India
Ministry of Health & Family Welfare
Directorate General of Health Services
Central Drugs Standard Control Organization
FDA Bhawan, New Delhi
Dated: BA +I 20/8
Notice
Sub: Uploading data of drug manufacturing facilities and approved drug formulations
on SUGAM portal- Guidelines issued -reg.
CDSCO has launched a module under SUGAM portal for uploading the data at
www.cdscoonline.gov.in 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. 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 an User Manual which will provide applicant a step by
step procedure for uploading the data. Copy of the user manual is enclosed herewith.
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.
>
(Dr. S. Eswara Reddy)
Drugs Controller General (India)
To
All Pharma Industry Associations
IDMA/IPA/FOPE/CIPI/FICCI/OPPI/Others
Copy to:
1. PPS to AS & DG, MoHFW
2. PPS to JS(R),MoHFW