CDSCO Publishes Final Risk Classification List for Class A Medical Devices
The Central Drugs Standard Control Organisation (CDSCO) has published the final risk classification list for Class A (non-sterile and non-measuring) medical devices under the Medical Devices Rules, 2017. This final list, contained in Appendix A, follows the publication of a draft list issued earlier this year and is now effective immediately. The classification confirms that these low-risk devices are exempted from most licensing requirements under the Rules, a measure intended to streamline regulatory compliance for manufacturers and importers of over 1,000 types of basic medical instruments and products.
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 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 Mandates Import of Drugs and Medical Devices Only Through Notified Ports
The Central Drugs Standard Control Organization (CDSCO) has issued a directive to the National Customs Targeting Centre (Cargo) to ensure that all imports of Drugs, Medical Devices, and Cosmetics are routed exclusively through the ports of entry officially designated under the Drugs Rules, 1945. The directive, dated October 7, 2025, emphasizes strict compliance with Rule 43-A of the Drugs Rules, 1945, which specifies the legal entry points for drugs into India.
CDSCO Clarifies Regulatory Pathway for Combipack Injections
The Central Drugs Standard Control Organization (CDSCO) has issued a clarification on the regulatory pathway for approving combipack products consisting of lyophilized dry powder for injection/I.V. infusion and its diluents. The guidance distinguishes between standard and altered combipack formulations, determining whether they require approval as a new drug.
CDSCO Seeks Comments on Braille Labeling for Medicine Strips
The Central Drugs Standard Standard Control Organization (CDSCO) has issued a notice inviting public comments on a proposal to introduce Braille inscriptions on medicine strips to assist blind and visually impaired people.
CDSCO Excludes Specific FDC from List of Unapproved Combinations
The Central Drugs Standard Control Organization (CDSCO) has issued a clarification stating that the Fixed-Dose Combination (FDC) containing Voglibose 0.2 mg and Metformin HCl (as SR form) 500mg is approved by the CDSCO and must be excluded from a previously circulated list of unapproved FDCs.
CDSCO Allows Revised MRP Sticker for Medical Products Following GST Rate Reduction
The Central Drugs Standard Control Organization (CDSCO) has issued an order allowing importers and manufacturers of medical devices to affix a sticker with the revised Maximum Retail Price (MRP) following a reduction in the Goods & Services Tax (GST) rate.
CDSCO Clarifies Regulatory Pathway for Pharmaceutical Cocrystals
The Central Drugs Standard Control Organization (CDSCO) has issued a circular clarifying the regulatory pathway for approving pharmaceutical cocrystals, stating that all such products derived from already approved active substances will be treated as a new drug.
ICMR and CDSCO Release Comprehensive Protocols for IVD Kit Evaluation
The Indian Council of Medical Research (ICMR) and the Central Drugs Standard Control Organisation (CDSCO) have jointly unveiled the first batch of 39 Standard In-Vitro Diagnostic (IVD) Evaluation Protocols. This initiative, a collaboration under a Memorandum of Understanding (MoU) between the two bodies, aims to strengthen the quality and availability of diagnostic kits in India, particularly for critical infectious diseases.
Streamlining Approval: IBSC Clearance Now Sufficient for Some Test Item Manufacturing
The Central Drugs Standard Control Organisation (CDSCO) has announced a procedural change that simplifies the requirement for biopharmaceutical manufacturers seeking permission to produce test items for examination, test, and analysis.
CDSCO Simplifies Medical Device Import Procedures with ‘Subsequent Importer’ Provision
The Central Drugs Standard Control Organisation (CDSCO) has announced a new measure to streamline the regulatory approval process for importing medical devices and In-vitro diagnostics (IVDs). Effective September 11, 2025, a separate provision for “Subsequent Importer” has been made functional within the CDSCO online portal.