Last Updated on December 31, 2023 by The Health Master
Risk-Based Inspections
The Gujarat Food and Drug Control Administration (FDCA) recently wrapped up the third phase of risk based inspections on four pharmaceutical companies over the past few months.
The move comes after the FDCA previously revoked 15 product licenses from six pharma companies based on similar inspections.
The risk based approach aims to ensure that drug quality is not compromised, and the recent inspections revealed that some companies were manufacturing not-of-standard quality (NSQ) products, including widely prescribed gastrointestinal medicines, vitamins, azithromycin for cold, and amoxicillin for bacterial infections.
The Ongoing Effort:
According to Dr. H G Koshia, the Gujarat FDCA Commissioner, risk based inspections will continue as part of the Center’s Zero Tolerance Policy towards compromising drug quality.
This aligns with recent pan-India Center-State Joint inspections.
The Gujarat FDCA has already canceled manufacturing licenses of two pharma companies after inspecting five companies for non-compliance with Good Manufacturing Practices (GMP) norms and quality standards.
These companies failed to provide stability data as per the prescribed norms, leading to the license cancellations.
Nationwide Scope:
The risk based inspections are being carried out across India, and NSQ medicines have been reported in several states, including:
- Uttarakhand (UK),
- Himachal Pradesh (HP),
- Madhya Pradesh (MP),
- Andhra Pradesh (AP),
- Gujarat.
In a larger crackdown, licenses of 18 Indian pharma companies were canceled based on risk-based inspections planned in December of the previous year.
This action was initiated by the Central Drugs Standard Control Organization (CDSCO) after the World Health Organization (WHO) held Indian pharma companies accountable for exporting contaminated medicines.
Inspection Details:
Earlier this year, a joint team of state and central licensing authorities inspected approximately 76 pharma companies across 20 states/Union Territories.
Among these, around 203 pharma companies were identified by the CDSCO, and more than 25 of them were issued show cause notices.
These risk based inspections are based on the current good manufacturing practices (cGMP) and good laboratory practices (GLP) as outlined in the Drugs & Cosmetics (D&C) Rules, 1945.
Areas of Focus:
During these inspections, the state drug licensing authorities and the Drugs Controller General of India (DCGI) jointly audit the compliance of manufacturers.
The key areas of inspection include:
1. Sanitation and Hygiene:
Ensuring the facilities adhere to proper cleanliness and hygiene standards to maintain the integrity of the drugs produced.
2. Self-Inspection:
Encouraging pharmaceutical companies to carry out regular self-inspections to identify and rectify any potential issues proactively.
3. Quality Audits:
Evaluating the quality control measures in place to guarantee that products meet the required standards.
4. Prevention of Cross-Contamination:
Implementing measures to prevent cross-contamination between different drug products during production.
5. Prevention of Bacterial Contamination:
Ensuring procedures are in place to minimize the risk of bacterial contamination during the manufacturing process.
Conclusion:
The risk based inspections conducted jointly by state and central licensing authorities play a crucial role in safeguarding the quality of pharmaceutical products produced in India.
By adhering to the current good manufacturing practices and good laboratory practices, pharma companies can contribute to maintaining the highest standards in the industry and prioritize the safety and well-being of consumers.
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