The Central Drugs Standard Control Organization (CDSCO) has recently flagged select batches of two widely used medications as spurious and identified 111 other drugs and formulations as not of standard quality (NSQ) in its November 2024 report.

Spurious Drugs Identified

The spurious drugs include:

Pan D: A popular antacid marketed by Alkem Laboratories.

Augmentin 625 Duo: An antibiotic marketed by GlaxoSmithKline Pharma

The CDSCO’s alert named the brands but did not disclose the manufacturers. Investigations revealed that the actual manufacturers had not produced these specific batches, indicating they are counterfeit products made by unauthorized entities using established brand names.

Not of Standard Quality (NSQ) Drugs

In addition to the spurious drugs, the CDSCO listed 111 drugs and formulations as NSQ. This designation means that the drugs failed to meet one or more quality parameters set by regulatory authorities. It’s important to note that this classification pertains only to the specific batches tested and does not necessarily implicate other products from the same manufacturers.

Regulatory Actions and Industry Response

The Union Health Ministry has initiated investigations into these findings. The identification of spurious drugs has raised concerns about the proliferation of counterfeit medications in the market. The pharmaceutical industry in India, a major global drug producer, has faced scrutiny over drug quality, especially following recent controversies involving Indian-made cough syrups linked to fatalities abroad.

Consumer Advisory

Consumers are advised to remain vigilant and purchase medications only from authorized pharmacies. Healthcare professionals should stay informed about these developments to ensure patient safety.

References
  1. CDSCO flags 2 drugs as spurious, another 111 fail quality test in Nov ’24, Business Standard, published on 28 Dec 2024.
  2. 111 drug samples tested in November found ‘not of standard quality’, The Economic Times, published on 28 Dec 2024.
  3. 111 drug samples tested in November found ‘not of standard quality’ CDSCO report, Directorate General of Health Services Ministry of Health & Family Welfare Government of India.

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