BY THE DIGITAL HEALTH LEADERS FOR THE DIGITAL HEALTH COMMUNITY
BY THE DIGITAL HEALTH LEADERS 
IPC Releases Draft Pharmacovigilance Guidance Document to Strengthen Standard February 26, 2024 The Indian Pharmacopoeia Commission (IPC) has stepped towards bolstering pharmacovigilance standards in India by releasing the Draft Pharmacovigilance Guidance Document for Pharmaceutical Products Version 2.0.
CDSCO Releases Regulatory Guidelines for Sampling of Drugs, Cosmetics, & Medical Devices February 19, 2024 Central Drugs Standard Control Organization (CDSCO) has unveiled comprehensive regulatory guidelines for the sampling of drugs, cosmetics, and medical devices to enhance drug quality surveillance across India.
Cabinet Approves MoUs for Medical Products Regulation Cooperation with Dominican Republic & Others January 19, 2024 The MoUs seek to strengthen collaboration, promoting interaction among regulatory bodies to address the challenge of substandard and falsified medicines in international markets.
CDSCO Expands NSWS Portal Services With 5 Additional Forms to Enhance Accessibility January 19, 2024 Out of five, four new forms catering to specific facets of drug manufacturing and clinical trials are already in effect from January 16, 2024.
Govt Launches National Single Window System Portal to Streamline Medical Device Approvals January 3, 2024 The newly launched system started operations from 1st January, 2024 .
AstraZeneca's COPD Treatment Gains Approval from CDSCO December 20, 2023 COPD, the second leading cause of death in India, constitutes over 50% of chronic respiratory diseases and is the third leading cause of death globally.
Draft NPP Calls for Streamlining Digital Healthcare & Reducing Environmental Impact November 9, 2023 The policy embraces digital technologies, including telemedicine, EHRs, and data analytics for healthcare and pharmaceutical innovation, using AI, machine learning, and blockchain.
CDSCO to Develop Digital Drugs Regulatory System for Effective, Unified Infrastructure November 7, 2023 The CDSCO plans to build this DDRS using open-source technology and standards similar to successful Digital Public Infrastructure (DPI) models. It aims for DDRS to be India's DPI for healthcare product regulation.
High-Risk Medical Device Manufacturers Granted License Compliance Extension October 23, 2023 The extension applies exclusively to manufacturers and importers who had already submitted their license applications to the central licensing authority before September 30, 2023.
CDSCO Approves India's 1st Living Drug '˜CAR'to Fight Cancer October 17, 2023 Marking a significant milestone in the countrys cancer care landscape, the Central Drugs Standard Control Organisation (CDSCO), has approved the first living drug called CAR (Chimeric Antigen Receptor) T-cell therapy.
Govt Extends Deadline to Class C & D Medical Device Manufacturers Facing Licence Approval Delays October 13, 2023 The Indian government has announced a six-month extension for existing manufacturers and importers of high-risk medical devices who have applied for licences.
After a Long Hiatus, Govt Now Mulling Deadline Extension to Medical Device Manufacturers October 6, 2023 This potential extension is in response to delays in granting new licenses required to sustain production, reported the Economic Times.
