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.
Government of India to Tackle Antimicrobial Resistance in Veterinary Sector
The Central Drugs Standard Control Organization (CDSCO) has initiated a step towards mitigating Antimicrobial Resistance (AMR) in the veterinary sector. In a directive issued to all State and UT Drugs Controllers, the CDSCO announced plans to establish a structured Antimicrobial Use (AMU) reporting framework.
Government Proposes Ban on Several Antimicrobials in Animals Due to Human Health Risk
The Ministry of Health and Family Welfare has issued a draft notification proposing a ban on the import, manufacture, sale, and distribution of several antimicrobials and their formulations for use in animals, citing potential risks to human health. This notification was published on May 22, 2025.
ESIC Stops Ondansetron Batch After Quality Test Failure
The Employees’ State Insurance Corporation (ESIC) has flagged a batch of Ondansetron Oral Solution 2 mg/5 ml as “Not of Standard Quality (NSQ)”, following a lab report from the Central Drugs Laboratory (CDL), Kolkata. The batch has failed to meet Indian Pharmacopoeia (IP) standards, specifically in the test for “Related Substances”. Details of the NSQ […]
CDSCO Seeks Feedback on Draft Guidelines for Similar Biologics in India, 2025
The draft guidelines aim to provide a clear regulatory pathway for manufacturers seeking marketing authorization for similar biologics in India. According to the CDSCO, these guidelines emphasize a comprehensive stepwise approach to demonstrate similarity between a proposed similar biologic product and its reference biological product (RBP).
CDSCO Updates Public Relations Office Hours to Better Serve Stakeholders
The CDSCO’s PRO will now be open to the public from 4:00 PM to 6:00 PM every day, excluding holidays. This adjustment in the schedule is intended to provide a consistent and dedicated timeframe for stakeholders to interact with CDSCO officials and seek clarification on regulatory matters.
CDSCO Enhances Online Portals with Tooltips for Streamlined Application Submissions
These tooltips function as interactive help aids, providing specific instructions and clarifications for each data field. By hovering the cursor over the designated information icon or help text adjacent to a field, users can access concise explanations of the expected input, formatting requirements, and any supporting documentation needed.
Drugs and Cosmetics (Compounding of Offences) Rules, 2025
Individuals or companies involved in the manufacture, import, sale, distribution, or any other activity covered under the Drugs and Cosmetics Act and its rules can apply to the designated compounding authority for the compounding of an offence. This application can be made either before or after the initiation of prosecution and must be submitted in the prescribed form along with relevant information and documents. Importantly, each company or person involved must submit an individual application.
CDSCO Revises Drug Alert List For November 2024 & January 2025
The Central Drugs Standard Control Organisation (CDSCO) has issued drug alerts for specific batches of Tofacitinib Tablets IP 5 mg (marketed as TOFAJAK TABLETS) and TELMA AM, declaring them 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.
India Achieves Milestone in Preventive Healthcare with Indigenous HPV Test Kits for Cervical Cancer Screening
India has marked another significant stride in preventive healthcare with the development of indigenously manufactured HPV test kits for cervical cancer screening. This achievement, spearheaded by the Department of Biotechnology (DBT) under the Ministry of Science & Technology, was lauded by Union Minister of State (Independent Charge) for Science and Technology during a joint review meeting held on April 23, 2025.
