EU to Place Environmental Conditions within GMP Framework

By inserting the regulations for environmental control among production regulations within the framework of GMP, legislation will have an impact on third world countries.

The Swedish authorities are pushing for tighter environment laws by the European Union targeting the pharmaceutical production by the third world countries in general and India in particular. The current proposal by the Swedish Medical Products Agency (MPA), if gets through, may put Indian manufacturing units under added pressure.

The health ministers of the EU have already informally discussed the proposal to revise the EU legislation on GMP and report by the MPA that was submitted to the Swedish government. The agency was commissioned to prepare the report in the wake of a report in 2007 by Joakim Larsson’s research team at Gothenburg University that published a study of the concentrations of medicinal products in purified wastewater from a purification plant in Patancheru outside Hyderabad in India. The pharmaceutical substances produced in the area are largely