The charity distributes medicines to 94 clinics in Africa
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A Leicester-based charity supplying drugs to health centres in Africa could close because the Environment Agency says it is breaking the law.
For more than 30 years, Intercare has collected medicines returned to UK GP clinics, all still in date and sealed, and sent them to centres in Africa.
But the Environment Agency said the drugs are classed as waste and under EU regulations must be buried in landfill.
Intercare has suspended its operations until the investigation is completed.
'Desperate and heartbroken'
In a statement, the Environment Agency said it could not comment on on-going investigations but pharmaceutical goods such as pills and medicines could contain a wide range of chemicals and drugs that could be harmful to both humans and the environment.
They added: "As the regulator, we have a duty to ensure that that this waste is being disposed of and handled correctly.
"Sometimes these drugs are shipped to other countries that may need them and while we recognise the intention is to be of assistance to developing countries they need to follow the controls.
"These rules help to make sure that waste from this country isn't dumped illegally overseas."
The charity's chief executive, Margaret Macdonald, said the investigation had come as a complete shock.
"I feel desperate and heartbroken because I know that in the clinics we serve, which are in the most poor, rural and isolated places in Africa, for many people our medicines are the only ones available for those who have no money," she said.
Intercare must now attend an interview with the Environment Agency, prior to a possible prosecution.
Dr Tony Jarvis, Intercare's medical director, said: "There are no double standards.
"We send in-date medicines and we also visit the units in Africa regularly so we have a contact with them and that all follows the World Health Organisation regulations."
Intercare sends medicines to 94 health centres in seven African countries.