Gujarat FDCA Revokes Licenses Of Two Entities Amidst Rigorous Inspection Campaign

Mumbai: In a bid to uphold stringent regulatory standards and ensure public safety, the Gujarat Food and Drug Control Administration (FDCA) has recently embarked on a series of risk-based inspections targeting establishments within the drug sector. This proactive approach has resulted in the cancellation of licenses of two entities, underscoring the authority’s unwavering commitment to quality assurance and regulatory compliance.

Dr H G Koshia, commissioner of the Gujarat FDCA, emphasized the significance of these measures, stating, “Our foremost priority is to safeguard the health and well-being of consumers by enforcing stringent regulations and conducting thorough inspections.”

The recent crackdown comes amidst a broader initiative to enhance oversight within the industry. With 54 drug testing laboratories operating in Gujarat, the FDCA has intensified efforts to scrutinize their operations and ensure adherence to established protocols. Out of these, approximately 12 labs have already undergone inspections, with four labs receiving show cause notices accompanied by stop testing orders.

Non-compliances include not keeping procurement records of impurities and reference standards, lack of adequate staff, improper maintenance of equipment and instruments and also not having latest edition of Indian Pharmacopoeia (IP).

Dr Koshia elaborated on the rationale behind these actions, emphasizing the importance of maintaining the integrity of testing procedures. “Ensuring the accuracy and reliability of laboratory testing is crucial for guaranteeing the quality and safety of pharmaceutical products,” he stated.

Furthermore, Dr Koshia highlighted the collaborative nature of the inspection process, involving cooperation with stakeholders to address any identified shortcomings. “We are working closely with laboratory authorities to rectify deficiencies and implement corrective measures to enhance overall standards,” he affirmed.

“The Gujarat FDCA taking action against two establishments and initiating risk-based inspections indicates their commitment to ensuring public safety and regulatory compliance in the food and drug sector. This move underscores their dedication to upholding standards and safeguarding consumer health,” according to Dr Koshia.

He further added that the FDCA’s proactive stance underscores its dedication to upholding regulatory standards and safeguarding consumer health. Through rigorous inspections and decisive regulatory actions, the authority remains steadfast in its commitment to maintaining the highest levels of quality and safety in medicines.

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