The number of warning letters from US FDA to Indian manufacturing sites has increased in the last five years. Four GMP compliance reports were issued to Indian companies in 2015 compared to an average of around eight in 2011 to 14. Thirty per cent of quality related warning letters and less then 5% drug recalls have also been attributed to Indian companies, according to official sources.
While companies realize the importance of building stronger quality and operations systems across their manufacturing facilities, quality systems have unfortunately not seen upgrades at a proportionate pace.
These were the perspectives shared in the India Pharmaceutical Forum 2016 organised by Indian Pharmaceutical Alliance (IPA) in collaboration with US FDA, European Medicines Agency (EMA), UK Medicines and Healthcare Products Regulatory Agency (MHRA) and Central Drugs Standard Control Organization (CDSCO) in Mumbai recently.
Hence in general also, the global pharmaceutical industry faces the challenge of upgrading quality systems and delivering life-saving medicines simultaneously. India is no exception. Industry has seen a rise in quality sanctions in recent years. Between 2008 and 2014, the number of product recalls and warning letters received by pharma companies globally tripled. In India too the pharmaceutical companies have had mixed success in upgrading their quality systems.
The IPA working jointly with McKinsey & Company as the knowledge partner has formed a Quality Forum to identify and focus on six areas for improvement in quality. The group recognises that quality issues have the potential to affect patients adversely.
Data reliability has emerged as an important area globally. Of the 19 quality related warning letters issued globally in 2014, 10 had data reliability issues. Similarly, in 2015, 9 out of 10 quality related warning letters issued globally (up to August 2015) cited data reliability concerns. Reflecting these concerns, the UK MHRA, WHO and Parenteral Drug Association (PDA) released fresh guidance documents in 2015 emphasizing data integrity and good record management.
Some of the improvement areas highlighted by IPA Quality Forum include accurate and contemporaneous data recording, access controls for sensitive data, audit trails, data storage and maintenance practices.
According to UK MHRA, investigation of anomalies is one of the most frequent defect categories observed in its inspections worldwide. A direct consequence of weak investigation systems is that companies often face recurring deviations impacting product quality. Improvement areas include problem definition, root cause analysis and comprehensive risk management processes.