Swedish proposals for stricter environmental requirements for pharma industry could impact API makers in countries such as India

Under a commission from the Swedish government, the nation's Medical Products Agency (MPA) has identified opportunities for strengthening the environmental requirements relating to the manufacturing of medicinal products with greatest emphasis on European Union and international efforts rather than national work. The report suggests, among other, the requirement for an environmental certification of the production facilities to be introduced to the legislation on Good Manufacturing Practice (GMP).

Results from Swedish research indicate that emissions from the manufacture of medicinal products in India are of an extent which might seriously affect human and animal health, as well as their environment. Pharmaceuticals are found in both ground- and drinking water.

Current studies show that levels of pharmaceuticals in "purified' waste water are above the level of a normal dose of a drug in a human being. With this background, the discharge of substances from the pharmaceutical production in the third world is of sincere concern.