BY THE DIGITAL HEALTH LEADERS FOR THE DIGITAL HEALTH COMMUNITY
BY THE DIGITAL HEALTH LEADERS 
Govt to Tighten Safety Norms for Life-Saving Medical Devices May 22, 2024 Key stakeholders, including the Department of Pharmaceuticals, NITI Aayog, and the Union Health Ministry, are involved in the ongoing discussions.
CDSCO Extends Deadline for Class C & D Medical Devices Cos by 3 Months May 21, 2024 The Central Drugs Standard Control Organisation (CDSCO) has extended the deadline for Class C and D medical device companies, allowing them to continue operations for three months despite pending license applications.
CDSCO Urges Medical Devices Stakeholders to Report Adverse Events to MvPI May 17, 2024 The MvPI plays a vital role in reporting and coordinating analysis of adverse medical device-related events, including in-vitro diagnostic devices.
CDSCO Centralizes Power for Issuing NOC Solely for Export of Unapproved, Banned, & New Drugs May 6, 2024 In a significant move, the Central Drugs Standard Control Organisation (CDSCO) has revamped its process for issuing No Objection Certificates (NOCs) exclusively to export unapproved, banned, or new drugs.
CDSCO Releases Draft Guidelines for IVD Medical Devices April 29, 2024 The Central Drugs Standard Control Organisation (CDSCO) has released a draft guidance document on stability studies concerning In-vitro Diagnostic Medical Devices (IVDMD).
CDSCO Issues Fresh Draft GDP Guidelines for Pharma Products April 15, 2024 This release follows the framework outlined in the WHO Technical Report Series (TRS) on Good Storage and Distribution Practices, aiming to curb the infiltration of spurious, adulterated, misbranded, and Not of Standard Quality (NSQ) products into the healthcare system.
DCC Urges State Authorities to Set Deadline for Updating Drug Details in Sugam Portal April 2, 2024 The Sugam Portal is a platform introduced by the Central Drugs Standard Control Organization (CDSCO) in India. It seeks to simplify regulatory processes related to drugs, cosmetics, and medical devices.
ICMR, CDSCO & MedTech Mitra Partner to Boost IVD Standards March 6, 2024 Through the streamlining of IVD testing and validation processes, this alliance promises to set new benchmarks for the healthcare diagnostics industry.
CDSCO Releases Revised Guidelines on Post-Approval Changes in Biological Products March 6, 2024 The Central Drugs Standard Control Organisation (CDSCO) has unveiled a draft of revised guidance for the industry concerning quality, safety, and efficacy documents for Post Approval Changes (PACs) in biological products.
CDSCO Shifts PSUR Submission Online March 1, 2024 To modernize regulatory procedures, the Central Drugs Standard Control Organisation (CDSCO) has shifted the submission process for Period Safety Update Reports (PSUR) concerning the marketing authorization of new drugs and others to an online system.
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.
