Taking forward the culture of compliance on current good manufacturing practices (cGMP) in India, IPR legal experts who are working in sync with global regulatory authorities on GMP have observed that Indian manufacturers who have been exposed to regulatory scrutiny have failed in areas related to root cause analysis and not keeping to terms with the evolving current GMPs followed globally.
They have pinpointed that there is a need to modernise GMP standards when the big pharma in India looks forward at manufacturing complex generics which has a market of over 2 billion dollars, according to industry estimates.
This is also in consonance with the growing number of audits to be taken up by global counterparts worldwide in the future with global regulators hiring drug inspectors for auditing sites in respective countries of engagement and operations for GMP compliance.
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. According to global regulatory observations, 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 in areas include problem definition, root cause analysis and comprehensive risk management processes.
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.
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 per cent drug recalls have also been attributed to Indian companies, according to official sources.
Over the past decades, the industry has invested heavily in upgrading its manufacturing plants to match international standards. Approximately 1400 manufacturing units in India are WHO GMP certified, and over 800 are UK MHRA approved. India continues to have the highest number of US FDA registered manufacturing facilities outside US.
The industry has strong capabilities in product development. Also, Indian pharmaceutical companies have the largest share of DMFs and ANDAs outside US.