Statistics extracted from the US Food and Drug Administration (FDA) records point to serious quality control issues in Indian drug manufacturing units, with as much as 60 per cent of data integrity violations between the years 2011 and 16 originating in India.

Many top pharmaceutical names are on the list – Wockhardt, Sun Pharmaceutical, Dr. Reddy’s Laboratories, Sandoz and Cadila Healthcare to name a few.

Of the 45 warning letters the FDA sent out during the period under review, 27 were to India, as per a report by Nomura Research.

Drug regulators accord high importance to data generated during research and manufacture, to establish whether processes are well managed and if the finished product is safe and of good quality. FDA’s decision to approve a drug depends upon data given to it. Any violation results in tough action. Currently, 15 plants in India have import alerts against them.

“Data reliability is a crucial issue and cannot be ignored. Indian companies are already working on improving data reliability and have come out with their own draft guidelines. I believe that in the near future, the proportion of warning letters on data reliability to Indian plants will come down,” says Vikas Bhadoria, director, Mckinsey & Company.


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