Central Government Restricts Use of Common Cold Drug Combination in Children Under Four
The Central Government has now mandated that all manufacturers of fixed-dose combinations of Chlorpheniramine Maleate and Phenylephrine Hydrochloride must clearly and prominently mention the warning “fixed dose combination shall not be used in children below four years of age” on the label, package insert, and any promotional literature associated with the drug.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For March 2025
The NSQ drug list specifies a total of 61 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 70 drugs that were detected to be deficient. Additionally, CDSCO has also identified 1 drug to be spurious.
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.
CDSCO Introduces Auto-Generated Market Standing and Non-Conviction Certificates for Medical Devices
To facilitate the transition to the new automated system, the CDSCO has announced that all MSC and NCC applications currently in the old workflow will be automatically rejected by the system. The CDSCO has issued a request to all concerned stakeholders to re-submit fresh MSC and NCC applications through the upgraded online system. This ensures that all applications are processed under the new automated workflow.
Government Tightens Rules for Transfer of SEZ-Manufactured Drugs to Domestic Market
These measures are designed to strengthen oversight of drugs moving from SEZs to the domestic market, safeguarding public health by ensuring that all drugs sold in India meet the required quality, safety, and efficacy standards. This will prevent potentially substandard or unregulated drugs from entering the domestic supply chain.
Government Tightens Quality Control on Drugs
The Indian government has reinforced its commitment to ensuring the quality and safety of drugs available in the market through stringent quality checks, a robust recall system, and enhanced online monitoring. Drugs Inspectors conduct random quality checks by drawing samples from the drug supply chain and CDSCO maintains a “Drug Alert” system on its website
Government Bans Chloramphenicol and Nitrofurans in Food-Producing Animals
The Indian government, through the Central Drugs Standard Control Organization (Veterinary Division), has issued a notification prohibiting the import, manufacture, sale, distribution, and use of drug formulations containing Chloramphenicol or Nitrofurans in any food-producing animal rearing system. This ban, effective immediately, comes in response to concerns about potential risks to human health. This notice was issued on April 2, 2025.
Government Seeks Input on Revision of Risk Classification of Cardiovascular & Neurological Medical Devices
The government has revisited the existing classification lists for Cardiovascular and Neurological medical devices and added new entries based on their classification as outlined in the First Schedule (Part I) of the MDR, 2017. To ensure a comprehensive and transparent process, the government is seeking input from all concerned associations and stakeholders by May 1, 2025.
Pharmacy Council of India Urged to Ban Forced Swim Test in Institutions
PETA India argues that the forced swim test is scientifically invalid: The test’s validity in accurately modeling human depression has been widely questioned by scientists. The test is also unduly cruel and causes significant distress and suffering to the animals involved.
NPPA Sets Retail Prices for 80 New Drugs
The National Pharmaceutical Pricing Authority (NPPA), under the Ministry of Chemicals and Fertilizers, has announced the fixation of retail prices for 80 new drug formulations, aiming to ensure affordability and accessibility for consumers.
