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.
CDSCO Adds To Functionality Of Online Applications For Clinical Trials
The Central Drugs Standard Control Organisation (CDSCO) has announced a shift towards online applications for adding clinical trial sites and changing Principal Investigators. CDSCO is now accepting these submissions through the SUGAM portal. The CDSCO has also implemented a “deemed approval” system for applications submitted through SUGAM.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For November 2024
The NSQ drug list specifies a total of 70 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 41 drugs that were detected to be deficient. Additionally, CDSCO has also identified 2 drugs to be spurious.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For October 2024
The NSQ drug list specifies a total of 34 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 56 drugs that were detected to be deficient. Additionally, CDSCO has also identified 3 drugs to be spurious.
CDSCO Organizes Round Table to Discuss Cosmetics Regulations with Stakeholders
The Central Drugs Standard Control Organization (CDSCO) has invited manufacturers, importers, and industry associations to a roundtable meeting to discuss issues related to cosmetics regulations. The meeting is scheduled for November 19, 2024, at 4:00 PM at CDSCO headquarters in New Delhi. It aims to foster dialogue and collaboration between regulators and industry representatives.
New Recruitment Rules for Medical Device Regulatory Positions
The rules specify the number, classification, and pay level for various medical device regulatory positions. The method of recruitment, age limit, qualifications, and other eligibility criteria for each post are also outlined. Existing employees in relevant positions will be deemed to have been appointed under these new rules.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For September 2024
The NSQ drug list specifies a total of 18 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. All of these 18 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 49 drugs that were detected to be deficient. Additionally, CDSCO has also identified 4 drugs to be spurious.
New Version Of Medical Device Adverse Event Reporting Form Released
The Central Drugs Standard Control Organization (CDSCO) has released a new version of the Medical Device Adverse Event Reporting Form under the Materiovigilance Program of India (MvPI), i.e. version 1.2. This form was released on October 8, 2024.
CDSCO Requires Registration Of Clinical Research Organizations
The Central Drugs Standard Control Organization (CDSCO) has announced amendments to the New Drugs and Clinical Trials Rules, 2019. These amendments aim to strengthen the regulatory framework for clinical research organizations (CROs) in India. CROs are now required to register with the Central Licensing Authority before conducting clinical trials.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For August 2024
The NSQ drug list specifies a total of 11 drugs that were detected to be deficient by State Lab Drugs Control Laboratory, Telangana. All of these 11 drugs were declared to be not of standard quality. The NSQ drug list for central CDSCO laboratories specifies a total of 48 drugs that were detected to be deficient. Additionally, CDSCO has also identified 5 drugs to be spurious.
