Mumbai: In a decisive move to enforce stringent regulatory standards, the Gujarat Food and Drug Control Administration (FDCA) has revoked the licenses of seven private drug testing laboratories. This action followed a series of risk-based inspections targeting 19 labs across Ahmedabad, Baroda, and parts of South Gujarat.
The inspections, which aimed to ensure compliance with critical norms related to impurities, reference standards validation, calibration, testing tools, and instrumentation, revealed significant violations. Dr. H G Koshia, commissioner of the Gujarat FDCA, detailed the findings and the subsequent actions taken.
“We have 54 drug testing labs in Gujarat, out of which 19 were inspected. Serious violations were detected, following which stop testing orders and show cause notices were issued. Seven labs were put under strict scrutiny, and they were directed to resume their operations only after achieving full compliance,” stated Dr. Koshia.
He further explained that the crackdown underscores the FDCA’s commitment to maintaining high standards in drug testing processes, which are crucial for ensuring the safety and efficacy of pharmaceuticals. The revocation of licenses serves as a stern warning to other labs to adhere strictly to regulatory requirements.
This initiative is part of a broader strategy to enhance the reliability and integrity of drug testing procedures in the state, ultimately aiming to safeguard public health. The FDCA has reiterated its zero-tolerance policy towards non-compliance and vowed to continue rigorous inspections across all remaining laboratories.
The affected labs are now required to implement corrective measures and demonstrate adherence to prescribed norms before they can resume operations. This move is expected to prompt all drug testing facilities in Gujarat to reinforce their compliance frameworks and ensure adherence to the highest standards of practices.
