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 Good Manufacturing Practices (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 exported to Europe and the United States, among other markets.

“Today a considerable share of pharmaceutical manufacturing and production of starting materials and semi-products takes place in low-cost countries, and many large companies plan to locate even more of their production there. In the first decade of the 21st century, Swedish research findings have revealed emissions from the manufacturing of medicinal products in India on a scale that can seriously impact the health of humans and animals, as well as the environment. Against this background, emissions of pharmaceutical substances from drug production in the third world are an urgent matter,” according to the final report by the MPA.

By inserting the regulations for environmental control among production regulations within the framework of GMP, legislation will also have an impact on third world countries. A further advantage of placing environmental requirements within GMP is that there is a well-developed and well-functioning inspection system for monitoring manufacturing and GMP. By placing environmental requirements within the framework of GMP, inspection rules will also apply to checking that environmental requirements are being observed, the report said.

“Among directives regarding medicinal products the obligation is added for manufacturers of medicinal products to comply with the requirements in a separate legal document, a new EU regulation in which emission levels for certain substances are stated. The new obligation among pharmaceutical directives should be inserted in the requirement to comply with GMP in production. A new EU regulation should be created. The point of departure in proposing a new legal document is that it should stipulate the pharmaceutical substances that need to be controlled in terms of emissions from production as well as the emission levels that are not permissible. Cosmetics legislation in the EU might serve as a model for structuring this document,” it said.

“What should receive top priority for a first step in the above-mentioned EU regulation are those pharmaceutical substances for which there is scientific evidence that the external environment, and thereby public health, is negatively impacted. First and foremost this concerns antibiotics, certain medicinal products with hormone-disrupting substances, and substances that can constitute a risk to the environment in that they are used and produced in large volumes. The new EU regulation should establish a procedure for how to identify further substances and how to determine concentration limits. These tasks will need to be addressed by some EU body that has the relevant environmental expertise,” according to the report.