CDSCO declares 59 drugs tested in August as Not of Standard Quality

 The Central Drugs Standard Control Organisation (CDSCO) recently released a troubling report revealing that 59 drug samples were declared Not of Standard Quality (NSQ) in August 2024. This list includes samples from well-known manufacturers, raising serious concerns about the integrity of pharmaceutical products available in the market. As the healthcare community and patients await clarity, it’s essential to understand the implications of this report.

The NSQ Report: Key Findings

According to the CDSCO, 48 NSQ samples were reported directly by the organization, while state regulators contributed 11 additional samples. Notable failures included:

• Clavam 625 (amoxicillin and potassium clavulanate tablets) from Alkem Health Science.
• Pan-D (pantoprazole gastro-resistant and domperidone prolonged-release capsules) also from Alkem Health Science.
• Cepodem XP50 (cefpodoxime proxetil and potassium clavulanate) from Hetero Labs Ltd.
• Paracetamol tablets and metronidazole tablets from public sector undertakings Karnataka Antibiotics and Pharmaceuticals Ltd and Hindustan Antibiotics Ltd.

These failures not only jeopardize patient safety but also call into question the quality control measures employed by these manufacturers.

The Spurious Drug Dilemma

Interestingly, some manufacturers have previously claimed that these NSQ samples were not produced by them, suggesting that spurious drugs might be infiltrating the market. This raises significant concerns about the sourcing and verification processes in place for pharmaceutical products. Ensuring the authenticity of medications is crucial, as counterfeit drugs can lead to ineffective treatments and pose serious health risks.

Compliance Issues Among States and Union Territories

A major area of concern highlighted in the CDSCO report is the lack of compliance among various states and union territories in submitting NSQ data. States like Andhra Pradesh, Tamil Nadu, and Gujarat, among others, failed to report any data for August 2024. The report also noted that some states submitted data in formats that did not comply with CDSCO guidelines.

This lack of timely and accurate reporting not only hinders regulatory efforts but also impedes the CDSCO's ability to inform the public and healthcare providers about potential risks.

Steps Towards Improvement

In response to these issues, the CDSCO has been proactive in changing its reporting format to enhance transparency. Since May 2024, the organization has been publicly listing states and union territories that fail to comply with NSQ data submissions. This increased scrutiny aims to motivate better compliance and accountability among state regulators.

The 64th Drugs Consultative Committee (DCC) meeting has emphasized the need for all state regulators to adhere to a monthly data submission schedule. The DCC has proposed the creation of a blacklist for manufacturers who repeatedly produce NSQ drugs, a step that could significantly improve the quality of medications available in the market.

Conclusion: A Collective Responsibility

The recent NSQ report serves as a critical reminder of the need for stringent quality control and accountability in the pharmaceutical industry. As healthcare professionals and patients, it’s vital to remain vigilant and informed about the medications we use.

The CDSCO's efforts to improve data reporting and manufacturer accountability are steps in the right direction. However, the collaboration of all stakeholders—including state regulators, manufacturers, and healthcare providers—is essential to ensure that the drugs reaching patients are safe and effective.

As we move forward, it’s imperative to foster an environment of transparency and compliance that prioritizes public health above all else. By working together, we can build a more reliable and trustworthy pharmaceutical landscape for everyone.