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MOSL: EXPERT SPEAK- Healthcare – Indian pharma striving for consistency in compliance

EXPERT SPEAK: Healthcare – Indian pharma striving for consistency in compliance; Companies on a ‘learning curve’ as regulations keep evolving

 

 Mr K Anand; CEO & MD, Qualiminds

Senior Pharma Industry Professional with over 35 years of experience in areas of Quality & Regulatory affairs.

He has been instrumental in setting up International Quality standards in reputed pharma companies like Lupin, Glenmark & Famy Care (now Mylan). Led large teams at Lupin, Glenmark, Dr.Reddy’s, Cadila, Famy Care to successful regulatory inspections (US, EU, TGA, ANVISA, WHO). His core competence has been to evolve QbD approach during development and regulatory filing of dossiers, Life Cycle Management of products, Good Laboratory Practices, Quality Management Systems

 We met Mr K Anand, CEO & MD of Qualiminds. Key takeaways:

• ‘Poor or lack of automation’ in manufacturing sites has not been the major source of concern for the US FDA or EU agencies. Instead, the absence of good ‘culture of quality’ has resulted in severe deficiencies and regulatory actions like 483s, warning letters and import alerts.
• However, in injectable facilities across India (and also across the world), poorly automated manufacturing processes resulting in excessive human interventions have caused serious concerns with the USFDA. Excessive manual operations/interventions result in microbiological contamination, which are often difficult to validate successfully.
• Poor skill level of operating staff on shop floor and laboratory, along with poor oversight on day-to-day activities, is another cause of serious deficiencies at many manufacturing sites. This is further compounded by inadequate training of employees to (a) attain the necessary skill-set, (b) ensure timely verification of training effectiveness and (c) be well qualified to undertake the jobs according to cGMP.
• Continuous internal review systems to identify gaps and thereby undertake effective Corrective and Preventive Actions (CA and PA) is another essential issue that the industry needs to address for staying on top of compliance requirements and avoiding regulatory actions.
• Despite the regulatory headwinds, the US specialty generics space remains interesting due to vast potential, limited competition and superior profitability.
• Indian regulatory agencies (DCGI and state FDAs) need to play a key role and be very stringent and proactive with their compliance standards for generic-generic medicines in India. This would not only build confidence of international bodies but also enhance healthcare standards and patient safety in India.