BY THE DIGITAL HEALTH LEADERS FOR THE DIGITAL HEALTH COMMUNITY
BY THE DIGITAL HEALTH LEADERS 
CDSCO Moves Clinical Trial Applications to Online Portal January 3, 2025 CDSCO has transitioned the clinical trial site addition and change of principal investigator application process to the Sugam portal. The move aims to streamline the submission procedure for clinical trials in India.
SSI Mantra Becomes First CDSCO Certified Robotic System for Telesurgery in India December 10, 2024 SS Innovations’ SSI Mantra becomes the first surgical robotic system in India to receive CDSCO approval for telesurgery and teleproctoring, revolutionising access to advanced healthcare.
India's Drug Regulatory Process 95% Digitised: Health Minister October 15, 2024 Union Health Minister JP Nadda announced 95% digitisation of India's drug regulatory processes, boosting transparency and efficiency in drug approvals and quality control.
CDSCO Becomes Affiliate Member of International Medical Device Regulators Forum October 4, 2024 CDSCO joins the IMDRF as an Affiliate Member, enhancing India's medical device regulatory system and fostering global collaboration.
IPA Defends Members After CDSCO Flags Quality Failures October 1, 2024 The Indian Pharma Alliance defended its members after CDSCO flagged 53 commonly used medicines for quality failures in its August 2024 report.
Over 50 Drugs, Including Supplements, Fail Quality Tests by India’s Drug Regulator September 26, 2024 The CDSCO identified 53 drugs as Not of Standard Quality (NSQ) through its routine random sampling process conducted by state drug officers.
CDSCO Launches New Digital Initiatives to Improve Pharma Regulation September 2, 2024 The Central Drugs Standard Control Organization (CDSCO) unveiled a series of digital initiatives to overhaul the pharmaceutical regulatory framework in India.
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.
