Sweden seeks GMP revisions to tackle environmental pollution
pharmafile | July 19, 2011 | News story | Manufacturing and Production |Â Â pharma manufacturing newsÂ
Wholesale shifting of pharmaceutical production to low-cost countries such as India and China is creating environmental impacts “on a scale that can seriously impact the health of humans and animals,” says Sweden’s Medical Products Agency.
The MPA recently submitted a report to the Swedish government on how EU environmental standards in pharmaceutical production can be strengthened, which was discussed at the Informal Meeting of Ministers for Health in Warsaw, Poland, on 6 July.
Its proposals would require changes to EU legislation on pharmaceutical Good Manufacturing Practices (GMP) to control “environmental emissions of substances stemming from pharmaceutical manufacturing” which could pose a threat to health. Any medicinal product placed on the EU market – regardless of source – would have to comply with the revised legislation.
“We use pharmaceuticals to remedy humans and animals, it is paradoxical that the production greatly contributes to threatening our health,” comments Charlotte Unger, environmental director at the MPA.
The report also suggests drawing up new EU regulation to specify which pharmaceutical substances should be controlled in terms of emissions, as well as permitted levels. The existing GMP framework should be updated to reference the new regulation, and priority would be given to substances known to be associated with harm, such as antibiotics and hormone-disrupting chemicals.
Procedures should also be put in place to identify additional chemicals which may be of environmental concern and to establish concentration limits for them.
“By inserting the regulations for environmental control among production regulations within the framework of GMP, legislation will also have an impact on third countries,” according to Unger.
One of the prompts for the report was the findings of a research team from Gothenburg University which looked at concentrations of medicinal products in purified wastewater from a purification plant in Patancheru outside Hyderabad in India in 2007. The plant received wastewater from around 90 pharmaceutical manufacturers.
The team found that high levels of medicines, including ciprofloxacin, were being pumped into the river and nearby lakes by the plant.
Before this research, the pharma industry often argued that the bulk of pharmaceutical compounds found in the environment derive from excreted metabolites in human waste or from improper disposal of unused medicines, rather than manufacturing plants.
And this is not just confined to emerging pharmaceutical markets. Last year, scientists at the US Geological Survey found concentrations of pharmaceuticals up to 1,000 times higher in two test outflows from wastewater treatment plants in the vicinity of pharmaceutical facilities compared to control plants (see: Study re-opens debate about pharma chemicals in wastewater).
“With drug production being relocated and emissions appearing in the third world, it is important for Sweden to impel the EU to undertake forceful measures”, notes the MPA report.
Phil Taylor
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