Last Updated on January 21, 2024 by The Health Master
Stringent actions by Gujarat FDCA
The Gujarat Food and Drug Control Administration (FDCA) has recently taken decisive action against pharmaceutical companies that failed to comply with industry norms.
In a bid to uphold drug quality and patient safety, the Gujarat FDCA canceled the licenses of two pharma companies and ceased production of another through risk-based inspections (RBI).
These inspections are part of a wider initiative following joint inspections conducted throughout India by the Centre and state authorities, with a Zero Tolerance Policy for any compromise on drug quality.
Risk-Based Inspections in Gujarat and Nationwide Efforts:
- Risk-based inspections are ongoing in Gujarat, aligned with pan-India Centre-State joint inspections.
- The Centre has mandated a Zero Tolerance Policy regarding drug quality and patient safety.
- In the recent third phase of risk-based inspections, a total of 5 companies were scrutinized.
- Out of the five inspected companies, two more received show cause notices (SCNs) for non-compliance.
Revision of Good Manufacturing Practice (GMP) Guidelines for MSMEs:
The Centre is currently in the process of revising its good manufacturing practice (GMP) guidelines specifically for medium, small, and micro enterprises (MSMEs) involved in drug manufacturing.
Also read : Understanding GMP, cGMP, and WHO-GMP
Inspection Findings:
As part of risk-based inspections, 162 units and 14 public testing labs underwent inspection.
The inspections revealed several areas of concern, including:
- Poor documentation practices
- Lack of process and analytical validation
- Infrastructural deficiencies
- Employment of unqualified personnel
- Faulty design of manufacturing and testing areas
Previous Instances of Action Taken:
- The Gujarat FDCA had previously canceled 15 product licenses of 6 pharmaceutical companies based on risk-based inspections.
- The inspections found that some products, such as widely prescribed gastrointestinal medicines and vitamins, were not of standard quality (NSQ).
- Additionally, medicines like azithromycin for colds and amoxicillin for bacterial infections were also found to be substandard.
Pan-India Impact of Risk-Based Inspections:
- Risk-based inspections are being conducted across India.
- Reports of NSQ medicines have surfaced in several states, including Uttarakhand, Himachal Pradesh (HP), Madhya Pradesh (MP), Andhra Pradesh (AP), and Gujarat.
Nationwide Risk-Based Inspections:
- In December of the previous year, the licenses of 18 Indian pharma companies were canceled based on risk-based inspections.
- This move was triggered by the World Health Organization (WHO) holding Indian pharmaceutical companies accountable for exporting contaminated medicines.
Joint Team Inspections:
- Earlier this year, a joint team of state and central licensing authorities inspected 76 pharma companies across 20 states/UTs.
- Around 203 pharma companies were identified, and more than 25 were issued show cause notices.
Understanding Risk-Based Inspections:
- Risk-based inspections are rooted in current good manufacturing practices (cGMP) and good laboratory practices (GLP) under the Drugs & Cosmetics (D&C) Rules, 1945.
- These inspections are jointly conducted by state drug licensing authorities and the Drugs Controller General of India (DCGI).
- The purpose of these inspections is to audit manufacturers’ compliance with critical areas such as sanitation, hygiene, self-inspection, quality audits, and the prevention of cross-contamination and bacterial contamination during production.
Disclaimer: This article contains information derived from Pharmabiz. Our team utilized an AI language model, to rewrite and present the news / article in a unique format.
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