CDSCO Launches Streamlined Online Export NOC System via SUGAM Portal
The Central Drugs Standard Control Organization (CDSCO) has launched a new, streamlined online Export No Objection Certificate (NOC) system on the SUGAM portal, aimed at enhancing “ease of doing business” for pharmaceutical exporters.
CDSCO Launches Online Registration for Clinical Research Organizations (CROs) via SUGAM Portal
The Central Drugs Standard Control Organization (CDSCO) has announced the launch of online registration for Clinical Research Organizations (CROs) through the SUGAM portal. This initiative follows the Ministry of Health and Family Welfare’s notification making CRO registration mandatory from April 1, 2025.
CDSCO Issues Stricter Guidelines for Action Against Spurious and Substandard Drugs
The guidelines aim to provide a uniform framework for State Drug Control Organizations to implement the Drugs and Cosmetics (Amendment) Act, 2008 effectively and ensure public health safety. The CDSCO guidelines emphasize a firm hand in dealing with manufacturing spurious or adulterated drugs, while also ensuring fair treatment for licensed manufacturers with minor quality variations.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For January 2025
The NSQ drug list specifies a total of 93 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. The NSQ drug list for central CDSCO laboratories specifies a total of 52 drugs that were detected to be deficient.
CDSCO Expands Online Application Process for Clinical Trial Modifications via SUGAM Portal
The Central Drugs Standard Control Organization (CDSCO) has announced the expansion of its online application process through the SUGAM portal to include applications for Clinical Trial Site Addition and change of Principal Investigator for clinical trials of biological products, specifically vaccines and rDNA products.
CDSCO Clarifies Gastro-Resistant & Delayed-Release Drugs as “New Drugs”
The Central Drugs Standard Control Organization (CDSCO) has issued a directive clarifying that gastro-resistant and delayed-release dosage forms of drugs are to be considered “New Drugs” under the New Drugs and Clinical Trials Rules, 2019. This includes enteric-coated tablets and capsules.
India Cracks Down on Unapproved Drug Exports
Communications have been sent to all State Drugs Control Authorities and Zonal Offices to immediately withdraw Export No Objection Certificates (NOCs) and Manufacturing Licenses granted for any combination of Tapentadol and Carisoprodol. Similar communications have been sent to Customs offices at notified ports to route all consignments of these products through CDSCO Port offices.
CDSCO Issues Final Call for Pre-1988 Fixed Dose Combination (FDC) Manufacturers to Submit Applications
CDSCO has decided to provide a final opportunity for manufacturers/ stakeholders holding licenses prior to October 1, 2012, to submit applications related to category ‘d’ FDCs. They are given until May 24, 2025 to comply.
CDSCO Renames Drug Safety Division to Post Marketing Drugs Safety Monitoring Division (PMDSM)
The Central Drugs Standard Control Organization (CDSCO) has announced the renaming of its existing PSUR/PV/AEFI Division to the Post Marketing Drugs Safety Monitoring Division (PMDSM), effective immediately. All official communications from the CDSCO should now use the new division name, PMDSM, in place of the former name.
Nimesulide Banned for Animal Use in India
The directive, issued to all State/UT Drugs Controllers, instructs them to alert their inspectorate staff and maintain strict vigilance over the manufacture, sale, and distribution of Nimesulide. Controllers are also required to take all necessary regulatory measures to prevent the illegal production and sale of the drug and ensure its misuse in animals is prevented.
