Industry

Gujarat FDCA cancels licenses of 2 Pharma Companies

Out of these, 18 Indian pharma companies had their licenses cancelled based on the risk-based inspections.

The Health Master

June 10, 2023

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Last Updated on September 3, 2023 by The Health Master

Gujarat FDCA: cancellation of licenses

Gujarat FDCA: The Gujarat Food and Drug Control Administration (FDCA) recently took action against pharmaceutical companies that failed to adhere to Good Manufacturing Practices (GMP) and quality standards.

In a series of risk-based inspections conducted on five companies, licenses of two pharma companies were cancelled due to non-compliance.

Additionally, the license of one section of another company was also revoked, as their products were found to be unstable and exhibited multiple failures during quality testing and analysis.

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Reasons for License Cancellation:

The Gujarat FDCA Commissioner, Dr. H G Koshia, stated that the licenses were cancelled because the companies were unable to produce stability data in accordance with the established norms.

This decision was made in the interest of public health and to ensure the quality and safety of pharmaceutical products.

Previous License Cancellations:

Prior to this incident, the Gujarat FDCA had already cancelled 15 product licenses of six pharma companies based on risk-based inspections.

These inspections revealed that certain companies were manufacturing substandard quality products, including widely prescribed gastrointestinal medicines, vitamins, oral rehydration salts (ORS), as well as medications like azithromycin for cold, amoxicillin for bacterial infections, and antimalarial medicines.

The issue of non-standard quality (NSQ) medicines has also been reported in other Indian states, including Uttrakhand, Himachal Pradesh (HP), Madhya Pradesh (MP), Andhra Pradesh (AP), and Gujarat.

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Pan-India Risk-Based Inspections:

Risk-based inspections are being conducted across India to address the issue of NSQ medicines.

In December of last year, the Central Drugs Standard Control Organization (CDSCO) planned massive risk-based inspections nationwide following the World Health Organization‘s (WHO) call to hold Indian pharma companies accountable for exporting contaminated medicines.

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Scope of Inspections and Show Cause Notices:

Over the past six months, a joint team comprising state and central licensing authorities inspected a total of 76 pharma companies across 20 states and union territories.

Out of these, 18 Indian pharma companies had their licenses cancelled based on the risk-based inspections.

The CDSCO identified approximately 203 pharma companies, and more than 25 of them received show cause notices.

Risk-Based Inspection Criteria and Compliance:

The risk-based inspections are carried out based on current good manufacturing practices (cGMP) and good laboratory practices (GLP) as outlined in the Drugs & Cosmetics (D&C) Rules, 1945.

These inspections involve evaluating compliance in areas such as sanitation, hygiene, self-inspection, quality audits, prevention of cross-contamination, and bacterial contamination during production.

Both the state drug licensing authorities and the Drugs Controller General of India (DCGI) collaborate to ensure manufacturer compliance with these critical standards.

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