Will Patancheru Become Pharma's Own Chernobyl?

Today, the terrifying image of Chernobyl was invoked to describe what could happen if the pharma industry fails to deal with the problem of active ingredients within the water supply (as seen and documented in Patancheru, India.)

It wasn't a tree hugging member of Greenpeace, a "60 Minutes" commentator or emotional journalist who made the comparison, but a seasoned engineer and specialist in process design: Girish Malhotra. If the whole issue of pharmaceutical effluents is not addressed comprehensively, Mr. Malhotra suggests, the industry may soon have a massive public health and PR issue on its hands.

For regulators, the issues are complex. Sweden already has a running start on most nations in studying the problem, as became clear two years ago when the topic surfaced in the global news. (For more on a brief discussion by Green chemistry and pharma experts, read on)

For manufacturers, the most urgent steps are straightforward, if not simple:  improve process yields, and address process variability through improved control (process analytical technologies (PAT) could play a role. Process yield.  Improved control. The language of chemical engineers is so much less colorful than that of environmentalists, but, in the end it gets the job done. But for more from Girish, read on.

Manufacturers already have economic incentives for embracing Quality by Design. Heparin added a public health component to these concerns last year.  Environmental issues add yet another dimension.
Or manufacturers can continue with business as usual.  After all, these are still only very low levels of active ingredients, and it can't be proven that they have an impact on human health at these levels.... If it ain't broke, it's validated and it's making money, why fix it?  (For the answers to these questions, please ask Ford or GM...)




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