Does GMP Need to be Upgraded?

Deadly Hyper-Pathogens From Pharmaceutical Plants – Does GMP Need to be Upgraded?

As reported by several media all over the world last week, hyper-pathogens that are resistent against multiple antibiotics have been found in waste water in the area of Hyderabad in India. According to a report in The Times of India from April 30th, “bacteria hat have developed resistance to over 90% of known antibiotics” were found by German scientists.

Pharmaceutical plants are polluting water with antibiotics

The occurrence of hyper-pathogens in the water was a result of  high concentration of several powerful antibiotics. The concentration that was measured was hundreds and for some thousands times higher than permitted. The water was polluted by waste water from the many pharmaceutical manufacturing plants in Hyderabad.

Producing medicine must not result in making people sick. We all have an ethical responsibility to make production safe for all “stakeholders”, this includes not just the patients, but also people working in the plants and living close to manufacturing plants. Health and life must not be a risk due to high concentration of antibiotics in water.

Do we need to consider additional GMP requirements?

These powerful hyper-pathogens that are resistant even against the strongest antibiotics are a dangerous and deadly thread. Maybe it is time to consider an enhancement of international GMP regulations that force the customers of these pharmaceutical plants, who have their headquarters in Europe and USA, to include the waste water treatment in their frequent GMP audits.

The article of The Times of India can be found here:

A report by German news magazine Tagesschau can be found here:

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