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.
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 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.
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.
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.
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.
CDSCO Publishes Not Of Standard Quality And Spurious Alert For February 2025
The NSQ drug list specifies a total of 56 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 47 drugs that were detected to be deficient. Additionally, CDSCO has also identified 1 drug to be spurious.
