Monday, July 21, 2008

US FDA in India - So What !

The fear of Audits is still alive! Even after at least 3 decades since the first Pharmaceutical facility was audited in India from US FDA, the nervousness to face a FDA inspection has not ended. Even the big Indian companies with good track record have to prepare for the audit much in advance. The audit exercise can only be compared with a father preparing for the marriage of his only daughter. He has to ensure that the marriage party gets a grandeur treatment and leaves the place with complete satisfaction.
However, in this process, the complete focus of a company is not on the quality of products being manufactured or quality systems, but on how to successfully appease the visiting auditors. This, therefore, takes a narrow approach which undermines the ethos of quality philosophy.
Now the recent news that FDA is planning to open their regional offices in India or China is creating hype in industry.
After all our long relationship with FDA (in facing large number of audits) has still not taught us anything new. Even the 21st centry approach, the vision documents from FDA seems to be irrlevant. There are no lessons learned from our past experiences.
And so is the worry that FDA is planning its base in your own city.

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