Gujarat FDCA Takes Action with Inspections and License Revocations

Industry experts have lauded the proactive measures taken by Gujarat FDCA.

May 11, 2024

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Food and Drugs Control Administration FDCA Gujarat — FDCA Gujarat

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Last Updated on May 18, 2024 by The Health Master

Gujarat FDCA

The Gujarat Food and Drug Control Administration (Gujarat FDCA) is taking a firm stand to guarantee public safety and drug quality through a series of targeted inspections across the state’s pharmaceutical sector.

This proactive initiative, focused on high-risk areas, has resulted in the cancellation of licenses for two establishments and heightened scrutiny of drug testing laboratories.

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Protecting Consumers Through Stringent Regulations

“Our primary objective is to safeguard the well-being of citizens by implementing robust regulations and conducting meticulous inspections,” declared Dr. H G Koshia, Commissioner of the Gujarat FDCA.

This decisive action underscores the FDCA’s unwavering commitment to pharmaceutical quality assurance and regulatory compliance.

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Intensified Scrutiny of Drug Testing Labs

As part of this broader effort to strengthen oversight, the FDCA has intensified its focus on the state’s 54 drug testing laboratories.

Rigorous inspections have already been conducted at roughly 12 of these facilities, with four labs facing show cause notices and stop testing orders due to non-compliance.

Identified Issues in Drug Testing Labs:

Lack of Procurement Records: Failure to maintain proper documentation for the acquisition of essential materials like impurities and reference standards.
Inadequate Staffing: Insufficient qualified personnel to ensure proper testing procedures.
Improper Equipment Maintenance: Neglecting the upkeep of critical laboratory equipment and instruments, potentially compromising testing accuracy.
Outdated Resources: Absence of the latest edition of the Indian Pharmacopoeia (IP), a crucial reference for drug standards in India.

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Maintaining the Integrity of Testing Procedures

Dr. Koshia emphasized the critical role of reliable drug testing in safeguarding public health.

“Guaranteeing the precision and dependability of laboratory testing is fundamental to ensuring the safety and efficacy of pharmaceutical products,” he stated.

Collaborative Approach to Address Deficiencies

The FDCA’s approach extends beyond mere punitive actions. Dr. Koshia highlighted the importance of collaboration:

“We are working hand-in-hand with laboratory authorities to rectify identified shortcomings and implement corrective measures to elevate overall standards within the industry.”

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Gujarat FDCA’s Commitment to Public Health

Industry experts have lauded the proactive measures taken by Gujarat FDCA.

“These actions exemplify the FDCA’s dedication to ensuring public safety and upholding stringent regulatory standards within the food and drug sector,” remarked by Industry Expert, a renowned specialist in pharmaceutical regulations.

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