Drug Alert List for October 2023
A total of 1105 samples were tested by the CDSCO. Based on the samples tested, CDSCO has found a total of 61 drugs, medical devices and cosmetics that are identified as being deficient.
CDSCO directs Implementation of e-HRMS 2.0 Portal for Officers
The e-HRMS 2.0 Portal provides end-to-end HR services to government employees. It will be used extensively for matters connected with the service of the officers. These include updation of service records, transfers, promotions, LTC, etc.
PAC Applications for Marketing Authorisations for Vaccines & Antisera Now Online
CDSCO launches online system for Post Approval Changes (PAC) with respect to Marketing Authorisations (MAs) for human vaccines and anti-sera.
New Timelines for Proposals for Digital Drugs Regulatory System
The CDSCO has extended the deadline for submission of EoIs to 16:00 hours on Wednesday, 7th December, 2023 to admn@cdsco.nic.in.
CDSCO invites Proposals for Development of Digital Drugs Regulatory System
The aim of this project is to develop the DDRS as a unified digital ecosystem that will replace existing portals. DDRS is envisioned to be a Single Window, Single Sign On, and Unified Portal for all regulatory activities in the field of pharmaceuticals. The development of DDRS represents a significant step towards enhancing regulatory systems in India, ensuring the availability of quality medicines for the country and the world.
Applications for PAC in Vaccine Clinical Trials Now Online
The Central Drugs Standard Control Organisation (CDSCO) has issued a circular on the launch of the online system Post Approval Changes (PAC) with respect to the clinical trials of vaccines and associated approvals. With the introduction of the online system of SUGAM portal, the CDSCO seeks to streamline the regulatory submission procedure.
CDSCO classifies In-Vitro Diagnostic Medical Devices under Medical Device Rules, 2017
This classification has been undertaken on the basis of intended use, risk associated with the device and other parameters. CDSCO has updated its List of In-Vitro Diagnostic Medical Devices (IVD Analyzers) and List of In-Vitro Diagnostic Medical Devices (IVD Instruments). It has also added List of In-Vitro Diagnostic Medical Devices (IVD- Specimen receptacle) and List of In-Vitro Diagnostic Medical Devices under provisions of sub-rule (2) rule 4 of the Medical Devices Rules, 2017.
Efficiency Measures Implemented for Document Submission to CDSCO
These measures are designed to expedite the processing of documents within the CDSCO, reducing paperwork and enhancing the overall efficiency of regulatory affairs. The move towards digital documentation aligns with the broader global trend of modernizing administrative processes and promoting sustainable practices.
CDSCO permits applicants of Class C & D Medical Device Licences to continue Operations
The Central Drugs Standard Control Organisation (CDSCO) has issued a circular clarifying that an existing manufacturer or importer of Class C or Class D medical devices can continue to import/ manufacture these devices till 12th April, 2024. This circular has been issued with the view to limit the disruption to business continuity.
CDSCO Grants Approval to Private Testing Laboratories to test Cough Syrups to be Exported
Central Drugs Standard Control Organisation (CDSCO) has granted approval to 3 NABL Accredited Private Testing Laboratories to test cough syrups to be exported by manufacturers and authorised persons of manufacturers/ exporters. This notice was issued on 13th September, 2023.
