Government Classifies Medical Devices for Interventional Radiology and Radiotherapy
The Central Drugs Standard Control Organization (CDSCO) has classified medical devices pertaining to Interventional Radiology and Radiotherapy under the Medical Devices Rules, 2017. This action follows the publication of draft risk classification lists earlier on January 6, 2025.
CDSCO Mandates Display of QR Code and Toll-Free Number for Adverse Drug Reaction Reporting
The Central Drugs Standard Control Organization (CDSCO) has issued a Circular directing all retail and wholesale pharmacy stores across the country to prominently display a designated Pharmacovigilance Programme of India (PvPI) QR Code and a Toll-Free Number for reporting Adverse Drug Reactions (ADRs).
CDSCO Mandates Indian Licensing for Medical Device Procurement
The Central Drugs Standard Control Organization (CDSCO) has issued a Circular dated November 17, 2025, to all procurement agencies, including hospitals and health institutions, mandating that a valid license issued by CDSCO or the State Licensing Authority (SLA) must be a compulsory requirement for the procurement of Medical Devices in India.
Ministry of Health Issues Corrigendum on Drug Testing Sample Size
The Ministry of Health and Family Welfare (MoHFW), under the Department of Health and Family Welfare, has issued a corrigendum to amend a condition regarding the sample size for drug testing in a previously published draft notification.
CDSCO Makes Online Filing Mandatory for Post Approval Changes in Cell and Gene Therapy Clinical Trials
The Central Drugs Standard Control Organization (CDSCO) has implemented a new digital system on the SUGAM Online portal for processing Post Approval Changes (PAC) related to Clinical Trials for Cell and Gene Therapeutics Products (CGTP). This move streamlines the regulatory submission process and mandates online filing for all related applications.
State Lab Issues Alert for Spurious Dry Cough Formula
The State Drug Testing Laboratory (SDTL) in Raipur, Chhattisgarh, has flagged a batch of the product Besto-Cof DRY COUGH FORMULA as purported to be spurious. The actual manufacturer, as per the label claim, has officially stated that the impugned batch was not manufactured by them, confirming the product’s status as spurious and subject to the outcome of an ongoing investigation.
Nationwide Alert Issued as 112 Drug Batches Declared Not of Standard Quality in September 2025
The Central Drugs Standard Control Organisation (CDSCO) and various State Drug Testing Laboratories have issued a comprehensive alert identifying numerous drug batches that failed quality testing in September 2025. The consolidated list comprises 112 instances of drug products—including antibiotics, cardiovascular medications, supplements, and specialized injections—that were declared Not of Standard Quality (NSQ).
CDSCO Publishes Extensive Draft Guidance for Medical Device Software Regulations
The Central Drugs Standard Control Organisation (CDSCO) has published a comprehensive draft Guidance Document on the regulatory requirements for Medical Device Software under the Medical Devices Rules (MDR), 2017. The guidance aims to harmonize India’s regulatory practices with global standards and bring clarity to the licensing, quality, and post-market surveillance of software used in healthcare.
CDSCO Launches Digital Monitoring System for High-Risk Solvents on ONDLS Portal
The Central Drugs Standard Control Organisation (CDSCO) has launched a Digital Monitoring System on its Online National Drug Licensing System (ONDLS) portal to enhance surveillance over the supply chain and quality of high-risk pharmaceutical solvents.
CDSCO Invites Comments to Address Discrepancy in New Drug Approval Process
The Central Drugs Standard Control Organization (CDSCO) has issued a notice inviting comments from all stakeholders regarding a regulatory discrepancy that affects the cost and complexity of obtaining approval for a new drug in India. The move is intended to initiate discussions on establishing a level playing field and fostering domestic research and development (R&D).
Health Ministry Orders Nationwide Crackdown on Contaminated Cough Syrups and Irrational Use
The Union Ministry of Health and Family Welfare convened a high-level meeting under the chairmanship of Union Health Secretary to address recent concerns regarding the quality and administration of cough syrups, particularly in children. The meeting, attended by top officials from the Ministry of Health, Department of Pharmaceuticals, ICMR, and Drugs Controller General of India (DCGI), resulted in strict directives for all States and Union Territories.
CDSCO Launches 100-Day Campaign to Publicize GST Rate Cuts on Healthcare Products
The Central Drugs Standard Control Organization (CDSCO) has launched a comprehensive 100-day awareness campaign to disseminate information about the recent reduction in Goods & Services Tax (GST) rates on medicines, pharmaceuticals, and medical devices, effective since September 22, 2025.