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.
Draft In-vitro Diagnostic Medical Device Adverse Event Reporting
The Indian government has released a draft adverse event reporting form for In-vitro Diagnostic Medical Devices (IVD-MDs) for public comments by March 5, 2025.
CDSCO Streamlines Cosmetics Registration with New Online Module for Additional Variants
The CDSCO has now added a new online module specifically for applications and permissions related to additional variants of already-approved cosmetic products. The new module will be implemented and available for use from February 22, 2025.
CDSCO Updates List of Approved FDCs
The CDSCO has now identified and corrected typographical errors in the earlier list of FDCs (Annexure-A) for which manufacturing licenses could be obtained directly from State Licensing Authorities.
India’s Drug Pricing Policy Focuses on Essentiality and Market-Based Mechanisms
The policy emphasizes several key principles, including regulating prices based on the essentiality of drugs, focusing price controls on consumer-level formulations (medicines) rather than bulk drugs or intermediates, and using market-based pricing mechanisms instead of cost-based pricing.
ICMR & CDSCO Seek Input On HMPV Real-Time PCR Evaluation Protocol
The current draft focuses specifically on laboratory performance evaluation of HMPV real-time PCR kits, with all clinical samples tested according to the candidate test’s instructions for use. The primary purpose is to evaluate the performance characteristics of these kits in diagnosing HMPV infection/disease.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For December 2024
The NSQ drug list specifies a total of 84 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 51 drugs that were detected to be deficient.
CDSCO Sub-Zonal Office in Uttarakhand Relocates to Dehradun
The Central Drugs Standard Control Organization (CDSCO) has announced the relocation of its Sub-Zonal Office in Uttarakhand. All official submissions and communications should now be directed to its new address at CDSCO, Sub-Zonal Office The Survey of India, Survey Chowk Campus Plot No. 68, 17 EC Road Dehradun-248001 Uttarakhand.
