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FOPE cautions on need to minimize human errors
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Nandita Vijayasimha, Bengaluru
July 30 , 2024
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The Federation of Pharmaceutical Entrepreneurs (FOPE) is underscoring the need to minimize human errors such as mislabelling or incorrect packing. This is crucial because errors disrupt workflows, cause delays, and necessitate rework, which ultimately affects productivity and operational efficiency. It damages the reputation of pharmaceutical companies, leading to a loss of trust among its customers, consumers, healthcare professionals, and regulatory bodies.
According to Chakravarthi AVPS, chairman, FOPE Telangana & Andhra Pradesh, India plays a crucial role as a global supplier, with Hyderabad emerging as a central hub for medicines production. Upholding high-quality standards and minimizing human errors are vital for the industry's success.
Pharma industry plays a pivotal role, providing not only medicines but also essential hope and improved quality of life. Maintaining high standards is crucial to counter negative perceptions and ensure the safety and effectiveness of medicines. The future of the industry lies in drug repurposing and the production of high quality generics, with India continuing to be recognized as the ‘pharmacy of the world’. The industry's ongoing success depends on its ability to uphold its reputation and address issues proactively, he added.
Delving on the Broken Window Theory, which highlights the importance of addressing minor issues to prevent larger problems, and the 80/20 principle, which demonstrates that a significant portion of issues arises from a small percentage of sources, Chakravarthi at the recently concluded FOPE with FABA Human Error Reduction Workshop said that maintaining the integrity of our pharmaceutical industry is profound. It is here FOPE serves as a crucial link between the pharmaceutical industry and regulatory authorities, advocating for the sector's interests and addressing critical issues.
Despite advanced robotic equipment and automatic visual inspections, small errors such as mislabelling or incorrect packing can still occur. These minor mistakes can lead to significant consequences, including product recalls and damage a company’s reputation, affecting both product quality and the company's future, said Chakravarthi.
Harish K Jain, president, FOPE said that most of the quality issues stem from human error, which can range from minor mistakes to significant blunders leading to financial losses, reputational damage, and safety hazards. Human errors have caused companies worldwide to shut down. While we often discuss medical errors like prescription mistakes or surgical errors, similar issues occur daily in the pharmaceutical industry.
If India is to become a global pharma leader in terms of value and volume, we must human error reduction. There are various ways to reduce human errors. It is here skill development, standardise processes, ensure effective communication with superiors, subordinates, and colleagues are paramount, stated Jain.
V B Kamalasan Reddy, director general, Drugs Control Administration, Government of Telangana said, “Regulatory bodies play a crucial role in maintaining this trust. If we fail, people will lose confidence in us, and we wound not be doing justice to our job. Running a pharma company is not like running a real estate business or a hotel; it involves public safety. If a doctor is negligent, it affects a few patients, but if a pharma company is negligent, it affects many people. Incidents like those in Gambia testify the severe consequences of negligence in the pharma industry.
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