The Central Drug Standard Control Organization (CDSCO) recently released a drug alert, flagging 48 formulations that failed to meet the necessary quality standards during a random drug sample test conducted in August 2024. The alert has raised concerns about the safety and effectiveness of several widely used medicines in India, prompting patients and healthcare providers to stay vigilant.

Which Drugs Failed?

The list includes several high-demand drugs that are commonly prescribed across India, including:

• Amoxycillin and Potassium Clavulanate Tablets (Mexclav 625) – Manufactured by Meg Lifesciences.
• Calcium and Vitamin D3 Tablets IP (Shelcal 500) – From Pure and Cure Healthcare.
• Metformin Hydrochloride Sustained-release Tablets (Glycimet-SR-500) – By Scott-Edil.
• Rifaximin Tablets (Rifmin 550) – From Legen Healthcare.
• Paracetamol Tablets IP 500 mg – Manufactured by Karnataka Antibiotics.
• Montair LC Kid (Montelukast Sodium & Levocetirizine Hydrochloride) – Produced by Pure & Care Healthcare.

These medications are crucial in treating a variety of conditions ranging from infections to diabetes, making this alert particularly significant.

Popular Medications Also Affected

Some well-known medicines were also found to be “Not of Standard Quality” (NSQ):

• Clavam 625 (Amoxicillin and Potassium Clavulanate), manufactured by Alkem Pharmaceuticals.
• Pan-D (Pantoprazole Gastro-Resistant & Domperidone Prolonged-Release Capsules), produced by Alken Health Science.

These brands are trusted by healthcare professionals and patients alike, further emphasizing the need for strict quality control measures.

Why Did the Drugs Fail?

The quality tests were conducted in various laboratories across India, including RDTL Chandigarh, CDL Kolkata, CDTL Mumbai, and RDTL Guwahati. Several reasons were cited for the failure of these batches:

• Failure of assay (active ingredient content was not up to standard).
• Dissolution test failure, where the drug did not dissolve properly in the body.
• Uniformity of weight discrepancies, meaning the tablets did not have consistent weight across batches.
• Completeness of solution issues, with drugs not dissolving fully.
• Presence of particulate matter or issues with clarity of solution.
• Failure of pH levels and description inconsistencies.

These quality control failures can affect the drug’s safety, efficacy, and overall therapeutic effect, making it imperative for manufacturers to address these issues.

What Does This Mean for Patients and Healthcare Providers?

For patients, the CDSCO drug alert serves as a warning to be cautious when using medications that might have been flagged. Healthcare providers, especially doctors and pharmacists, should stay updated on such alerts to avoid prescribing or dispensing substandard medications. Consumers need to verify the batch number and manufacturer of their medication to ensure it has not been affected by the CDSCO’s alert.

The Importance of CDSCO Drug Alerts

These regular updates from CDSCO are part of India’s larger effort to ensure drug safety and quality in the pharmaceutical industry. The alert system helps prevent the sale and distribution of medicines that could potentially harm patients, ensuring that only the highest quality products reach the market.

By regularly testing drug samples, the CDSCO contributes to a safer healthcare environment, protecting patients from substandard or spurious medications. Manufacturers are held accountable for the quality of their products, ensuring strict adherence to guidelines set forth by the Indian Pharmacopoeia and other global standards.

NOT OF STANDARD QUALITY ALERT FOR THE MONTH OF AUGUST– 2024

Conclusion

The CDSCO’s drug alert for August 2024 serves as an important reminder of the need for strict quality control in the pharmaceutical industry. As consumers, patients, and healthcare providers, it’s crucial to stay informed about drug safety alerts to ensure that only safe and effective medicines are being used. By addressing the issues identified, manufacturers can help rebuild trust in their products, ensuring better health outcomes for patients across India.

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