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Are we Indians subjected to lower quality pharma manufacturing standards than people in the developed world? Don’t Indians deserve medicines from manufacturers that follow GMP (Good Manufacturing Practices)?  Why are Indian pharma regulators doing such a poor job in pointing out poor standards amongst Indian Pharma companies, while American FDA inspectors come to India and can point out problems in so many of the Indian exporting factories every year? 

The US FDA routinely inspects the factories and processes of Indian pharmaceutical companies that export drugs and formulations.

Almost every year, many Indian manufacturers receive notices from the FDA team. The FDA team finds problems in the quality standards of several of them.

For example, this year, many of the companies, including some of the best-known names, find themselves warned for violations. Check out this article in the Economic Times –

Why are established Indian exporters who have so much experience and talent, still unable to follow standards?

If this is the state of the companies that export to the USA, I can very well imagine the conditions in companies that manufacture medicines for the Indian consumer.

Why is the Indian regulator unable to identify problems and enforce standards? Is it a lack of talent, resources, technology, or training? Whatever the issues, it is clear that the Indian regulator is unable to do as thorough a job as the American FDA teams do.

Are we better off by outsourcing the implementation of our regulations to the regulator of a developed country? 

Or, should we hire experienced regulatory officials from the developed world to head and manage our FDA? That way, the skills and capabilities of our FDA would improve.

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