Current Situation: CGMP, India & USA

– Ajaz Hussain, Management Consultant

 

Poor data integrity practices noted by US FDA & UK’s MHRA at several companies in India

 • Remediation poses several challenges. How to understand why?

 It has been alleged that “Chalta-Hai” attitude etc., are part of the cause…

 • Understanding human behavior is critical. What may be the root cause of noted ‘cluster’ of challenges?

 Both US and UK regulators have acknowledged that many companies in India state-of-the art 

• Reason for optimism. It is already happening.

 Authorities in India have expressed displeasure on the notion of dual standards

 • Signal standard will take time. How to move in this direction and create a win-win opportunity?

 Please see the complete presentation @ http://www.slideshare.net/a2zpharmsci/data-

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