Environmental pollution risk high in Indian pharma manufacturing factories: Study

Environmental risk posed by the pharmaceuticals production facilities in India is too high, according to a study report.

Emissions and other effluents originating from pharmaceutical manufacturing facilities were found to be at a level that could seriously affect human and animal health, besides posing definitive risks to the environment.

The study conducted in 90 companies in and around Hyderabad during the period 2006 and 2007, funded by the Swedish International Development Cooperation Agency, came out with the conclusion that level of harmful emissions from most of the active pharmaceutical ingredient (API) manufacturing factories were exteremely high.

An analysis of the waste thrown out by the API manufacturing plants showed the presence of drugs including the antibiotic ciprofloxacin, at concentrations of up to 31,000 micrograms per litre, and the antihistamine cetirizine, at up to 1,400 micrograms per litre.

Some of the API factories released up to 45 kilograms of ciprofloxacin a day into the nearby river – the equivalent of 45,000 daily doses, the analysts concluded.

Leading agencies like Medical Products Agency (MPA) of Sweden has raised seriuos concerns on the discharge of toxic substances from pharmaceutical production in the third world and suggested change in the regulations on good manufacturing practices to make environmental certification mandatory for API units.

MPA also suggested amendment in EU legislation concerning the pharmaceutical industry so as to link drug approval process to environmental risk assessment.

If there is any risk of negative environmental effect during assessment, the marketing approval for the drug should be denied, MPA proposed.

A significant part of the current manufacture and production of raw materials or intermediate products takes place in low-cost countries and many large companies are planning to place even more of their production there.

National legislation is insufficient and these measures are better met with harmonised EU legislation, since level of requirements also may affect conditions outside the EU, MPA maintained.

MPA has submitted the these recommendations to the Swedish government and it would be placed for public consultation at national level.

After consutations, the Swedish government may approach the European Commission for the amendment in the EU legislations, reports said.