Gujarat FDCA Cracks Down on Pharmaceutical Manufacturing Violations

The Gujarat FDCA's commitment to ensuring pharmaceutical safety extends beyond the recent actions.

Food and Drugs Control Administration FDCA Gujarat
FDCA Gujarat

Last Updated on June 15, 2024 by The Health Master

Gujarat FDCA

The Gujarat Food and Drug Control Administration (Gujarat FDCA) has intensified its efforts to safeguard public health by taking stringent actions against pharmaceutical companies failing to adhere to Good Manufacturing Practices (GMPs).

This crackdown comes after inspections conducted between January and March 2024 revealed serious hygiene and quality control lapses in 14 out of 23 inspected companies.

Immediate Stoppage and Regulatory Scrutiny:

Protecting Patient Safety:

To prioritize public health, the Gujarat FDCA issued immediate stop manufacturing orders to 14 companies exhibiting critical violations.

This decisive action ensures these companies cease production until they meet the necessary GMP standards.

Show Cause Notices for Potential Violations:

Nine additional companies received Show Cause Notices (SCNs) requiring them to explain discrepancies identified during inspections.

These SCNs serve as a warning and an opportunity for companies to address potential non-compliance issues.

Continued Focus on Quality Control:

The Gujarat FDCA’s commitment to ensuring pharmaceutical safety extends beyond the recent actions.

Here’s a glimpse into their ongoing efforts:

Previous Enforcement Actions:

In November 2023, similar regulatory actions were taken against 11 pharmaceutical companies in key Gujarat cities for non-compliance with GMPs.

This highlights the Gujarat FDCA’s consistent focus on maintaining quality standards.

Focus on Micro, Small & Medium Enterprises (MSMEs):

The November 2023 inspections specifically targeted hygiene, quality control, and GMP adherence in MSMEs.

This indicates the Gujarat FDCA’s recognition of the potential vulnerability within smaller companies and their proactive approach to address quality concerns.

Strict Licensing Requirements:

Following phase-2 inspections last year, only one company in Ankleshwar, Bharuch district, received approval to resume operations.

This emphasizes the Gujarat FDCA’s strict adherence to licensing requirements (Form 25 & 28) as a safeguard for quality production.

Past Enforcement Actions Set Precedent:

The recent crackdown builds upon a series of actions taken by the Gujarat FDCA in June 2023.

These prior enforcements involved:

Production Halts Due to GMP Violations:

Several manufacturing plants faced production stoppages due to non-compliance with GMPs.

This included inadequate maintenance of crucial equipment impacting product quality.

Focus on Equipment Maintenance:

The Gujarat FDCA highlighted the importance of proper maintenance for analytical instruments and production equipment, emphasizing their role in ensuring consistent product quality.

Vadodara Scrutiny:

Two companies in Vadodara received SCNs, and four product licenses were revoked due to identified quality issues.

This exemplifies the Gujarat FDCA’s thorough inspection process across the state.

Vetting Veterinary Drug Production:

The Gujarat FDCA’s commitment to safety extends beyond human pharmaceuticals. During the third phase of inspections, four companies involved in veterinary drug production were scrutinized.

Three of these companies received stop manufacturing orders following SCNs for quality lapses that could compromise animal health, particularly in the production of oral solid dosage forms.

This comprehensive approach by the Gujarat FDCA demonstrates their dedication to safeguarding public health by ensuring adherence to GMPs across the pharmaceutical industry in the state.

Their ongoing efforts protect not only human patients but also animals relying on veterinary medications.

Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.

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