Gujarat FDCA Revokes Licenses of 7 Drug Testing Laboratories

May 23, 2024

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Food and Drugs Control Administration FDCA Gujarat — FDCA Gujarat

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Last Updated on June 7, 2024 by The Health Master

Gujarat FDCA

In a significant move to prioritize public health and ensure the safety and efficacy of medications, the Gujarat Food and Drug Control Administration (Gujarat FDCA) has revoked the licenses of seven private drug testing laboratories.

This decisive action follows a series of targeted inspections aimed at identifying and addressing non-compliance with critical quality control standards.

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Risk-Based Inspections Uncover Violations

The Gujarat FDCA conducted risk-based inspections across 19 drug testing laboratories located in Ahmedabad, Baroda, and South Gujarat.

These inspections focused on verifying adherence to essential regulations related to:

Impurities Testing: Ensuring the absence of harmful contaminants in medications.
Reference Standards Validation: Guaranteeing the accuracy and reliability of testing procedures.
Calibration: Maintaining the precision of analytical equipment.
Testing Tools and Instrumentation: Verifying the functionality and proper use of drug testing laboratory instruments.

The inspections revealed significant violations in these areas, prompting the Gujarat FDCA to take decisive action.

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Gujarat FDCA Commissioner Emphasizes Strict Compliance

Dr. H G Koshia, Commissioner of the Gujarat FDCA, elaborated on the findings and subsequent steps taken:

“Out of the 54 drug testing laboratories operating in Gujarat, 19 underwent inspections. We identified serious non-compliance issues, leading to the issuance of stop-work orders and show-cause notices.”
“Seven drug testing laboratories faced particularly severe violations and were subjected to stricter scrutiny. These drug testing laboratories will only be allowed to resume operations after demonstrably achieving full compliance with all regulations.”

Focus on Public Health and Drug Quality

Dr. Koshia further emphasized the importance of this initiative:

“This crackdown underscores the Gujarat FDCA’s unwavering commitment to upholding the highest standards in drug testing processes. These procedures are vital for ensuring the safety and effectiveness of medications consumed by the public.”
“The revocation of licenses serves as a strong message to all drug testing laboratories in the state. Strict adherence to regulatory requirements is paramount.”

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Zero-Tolerance Policy and Ongoing Inspections

This action signifies the Gujarat FDCA’s zero-tolerance policy towards non-compliance in drug testing.

The initiative is part of a broader strategy to strengthen the reliability and integrity of the entire drug testing system within Gujarat, ultimately safeguarding public health.

The Gujarat FDCA has vowed to continue rigorous inspections across all remaining drug testing laboratories.

The affected drug testing laboratories must now implement corrective measures and demonstrate complete compliance with established norms before they can resume operations.

This decisive move is expected to serve as a wake-up call for all drug testing facilities in Gujarat, prompting them to reinforce their compliance frameworks and prioritize the highest quality standards in their practices.

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