CDSCO

Health Ministry Bans 156 Fixed Dose Combinations August 23, 2024 The ban includes commonly used medications for cold, fever, and antibacterial and antifungal treatments. The ministry cited these combinations as "irrational" and noted that safer alternatives are available.

India Considers Waiving Clinical Trials for EU-Approved Medical Devices July 31, 2024 If approved, this would result in an amendment to Rule 63 (1) of the Medical Devices Rules, 2017, to formally include the EU in the waiver list.

3,053 Drugs Found Substandard & 424 Adulterated in FY 22-23: Govt Reports July 31, 2024 In FY 2022-23, a total of 96,713 drug samples were tested, of which 3,053 were found not to meet standard quality.

Health Minister Nadda Calls for Transparency in Drug Regulations to Achieve Global Standards July 18, 2024 Nadda urged CDSCO to develop a roadmap with timelines to achieve global standards in its mandated activities.

KPRDO Urges CDSCO to Include Pharmacy Associations' Insights in DCC Discussions July 5, 2024 The Karnataka Pharma Retailers & Distributors Organisation (KPRDO) has called on the Central Drugs Standard Control Organization (CDSCO) to include pharmacy associations' insights during the Drug Consultative Committee (DCC) Subcommittee's discussions on Rule 64 Part VI of the Drugs and Cosmetics (D&C) Act.

Majority of SLAs did not Submit NSQ Data in May: CDSCO June 24, 2024 As per the latest Central Drugs Standard Control Organisation (CDSCO) report, a significant number of State Licensing Authorities (SLAs) have failed to submit monthly data on Not of Standard Quality (NSQ) drugs despite repeated directives from the Central Licensing Authority (CLA).

CDSCO Releases Draft Guidance on Pharmacovigilance for Vaccines June 4, 2024 The Central Drugs Standard Control Organisation (CDSCO) has published a draft guidance document on pharmacovigilance requirements for human vaccines, inviting feedback from stakeholders.

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).