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The Central Drugs Standard Control Organisation (CDSCO) has recently issued a drug safety alert, highlighting 93 medicine batches that failed to meet standard quality criteria during random sample testing in January 2025. This action underscores the CDSCO’s commitment to ensuring the safety and efficacy of pharmaceutical products in the Indian market.
Identified Non-Standard Quality Formulations:
The list of drugs declared not of standard quality includes:
- Aceclofenac and Drotaverine Hydrochloride Tablets (100 mg/80 mg)
- Manufacturer: Regent Ajanta Biotech
- Compound Sodium Lactate Injection I.P (Ringer’s Lactate I.P)
- Manufacturer: Paschim Banga Pharmaceuticals
- Paracetamol, Cetirizine Hydrochloride & Phenylephrine Hydrochloride Tablets (WINCOLDZ)
- Manufacturer: Wings Biotech
- Betahistine Dihydrochloride Tablets I.P (Betahox8)
- Manufacturer: Jackson Laboratories
This list is not exhaustive; for a comprehensive overview, please refer to the CDSCO’s official communications.
Implications for Public Health:
The identification of these substandard formulations raises significant concerns regarding patient safety and treatment efficacy. Patients using these medications may experience reduced therapeutic benefits or potential adverse effects. It is crucial for healthcare professionals to stay informed about such alerts and review patients’ current medications accordingly.
Regulatory Actions and Recommendations:
Following the detection of these substandard drugs, the CDSCO has recommended the following actions:
- Market Withdrawal: Immediate removal of the affected batches from the market to prevent further distribution.
- Patient Notification: Informing patients currently using these medications about potential risks and advising them on alternative treatments.
- Manufacturer Investigation: Manufacturers are required to investigate the root causes of quality failures and implement corrective measures.
Staying Informed:
Healthcare professionals and patients are advised to regularly consult the CDSCO’s official website and trusted medical news sources for updates on drug safety alerts. Being informed ensures the use of safe and effective medications, aligning with the goal of optimal patient care.
Disclaimer: This article is based on information from the CDSCO and related sources. The list of affected drugs may not be exhaustive. Patients should consult healthcare professionals for personalized medical advice. The author and publisher do not assume responsibility for any adverse outcomes resulting from the use of the medications mentioned.
Source: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=MTI1NTY=
