CDSCO Revises Drug Alert List For May 2025
A drug alert for the month of May 2025 (revised) flagged a batch of Tranexamic Acid Tablets IP (Trenaxa 500), bearing batch number 18242021A, with a manufacture date of August 2024 and an expiry date of July 2027. The reason for failure was related to the “Identification and Assay of Tranexamic Acid.”
Deadline for WHO GMP COPP Applications via ONDLS Portal Extended to August 15
The Central Drugs Standard Control Organization (CDSCO) has extended the deadline for mandatory online submission of WHO GMP Certificate of Pharmaceutical Product (COPP) applications through the ONDLS portal to August 15, 2025. The earlier deadline of July 15, 2025 has been extended by a month following concerns raised by industry stakeholders.
CDSCO Mandates Online Submission for Cell and Gene Therapy Clinical Trial Applications via SUGAM Portal
The Central Drugs Standard Control Organization (CDSCO) has announced that all Clinical Trial Applications (Phase I, II, and III) for Cell and Gene Therapeutic Products (CGTP) must now be submitted exclusively through its online portal system, SUGAM. This notice was issued on July 9, 2025.
CDSCO Form For Public Hearing with DCG(I) for Direct Stakeholder Engagement
The Central Drugs Standard Control Organization (CDSCO) has announced the implementation of a new “walk-in meeting” system, providing a direct channel for applicants and stakeholders to engage with the Drugs Controller General of India (DCG(I)) at the CDSCO Headquarters. This initiative aims to streamline communication and offer a direct avenue for addressing complaints, grievances, and suggestions. This public notice was issued on July 7, 2025.
Drug Manufacturers Must Now Apply for COPP via ONDLS Portal
The Central Drugs Standard Control Organization (CDSCO) has mandated that all applications for the WHO- GMP Certificate of Pharmaceutical Product (COPP) be submitted exclusively through the Online Drugs Licensing System (ONDLS) portal. This directive was issued on June 25, 2025 and will be effective from July 15, 2025.
Indian Regulators Ease Medical Device Sterilization Norms
The Central Drugs Standard Control Organisation (CDSCO) has clarified that manufacturers outsourcing sterilization activities will no longer be required to obtain a separate “loan license.” This decision, culminating from extensive deliberations by expert committees, introduces new requirements for documentation and labeling to ensure product quality and safety.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For May 2025
The NSQ drug list specifies a total of 126 drugs that were detected to be deficient by State Lab Drugs Control Laboratories. The NSQ drug list for central CDSCO laboratories specifies a total of 58 drugs that were detected to be deficient. Additionally, CDSCO has also identified 2 batches of 1 drug to be spurious.
CDSCO Directs State Authorities to Compile List of Approved Veterinary Drugs
The Central Drugs Standard Control Organization (CDSCO), Veterinary Division, has issued a directive to all State and Union Territory Drugs Controllers, requesting a comprehensive list of manufacturing permissions granted for veterinary drug products. This includes antibiotics, Fixed-Dose Combinations (FDCs), and their premixes intended for veterinary use.
Health Ministry Proposes Amendments to Drugs Rules, 1945
The Ministry of Health and Family Welfare has published draft rules to further amend the Drugs Rules, 1945. These proposed changes, made after consultation with the Drugs Technical Advisory Board, aim to update regulations concerning the testing of parenteral solutions, the supervision of drug sales, and conditions for drug licenses.
CDSCO Issues Guidelines for Safe Disposal of Expired and Unused Drugs to Combat AMR
The Central Drugs Standard Control Organisation (CDSCO) has released guidelines for the safe and proper disposal of expired and unused medicines and drugs. This initiative aims to protect public health, animal health, and the environment, while also addressing the growing concern of Anti-Microbial Resistance (AMR).
Government Clarifies Labeling Permissions Under Rule 104A for Imported Drugs
The Central Drugs Standard Control Organization (CDSCO) issued a clarification regarding labeling activities for imported drugs, in line with Rule 104A of the Drugs and Cosmetics Rules, 1945. According to the Office Memorandum dated May 26, 2025, the CDSCO emphasized that the permission granted under Rule 104A—pertaining to labeling, overprinting, stickering, or stamping—is applicable strictly for imported drugs.
CDSCO Revises Drug Alert List For January 2025 Again
The Central Drugs Standard Control Organisation (CDSCO) has issued drug alerts for specific batch of TDmex
Colecalciferol (Vitamin D3) Tablets B.P, declaring it as potentially spurious following investigations into their quality. Consumers and healthcare providers are advised to stay informed about such alerts issued by regulatory authorities to ensure the safety and efficacy of the medications they use or dispense.