Malawi lying on testing emergency drug kits?

Malawi Government has claimed through the Ministry of Health and Pharmacy, Medicines and Poisons Board (PMPB) that the drugs procured by donors through Unicef under the emergency kit system are tested in Malawi.

But this contradicts what Unicef officials said at a meeting with some SWAp donors in Lilongwe a couple of weeks ago that the drugs were not tested in Malawi because government was convinced that the companies supplying them were pre-qualified and that the drugs went through rigorous quality assurance processes.

The Drugs and Poisons Act makes it mandatory for any drug coming into this country to be tested and certified by PMPB before being consumed by the public.

Parliamentary Committee on Health chairperson Paul Chibingu said the committee will take up the matter with the Ministry of Health during their meeting scheduled for May this year. He said the committee was not involved when government received the drugs.
The Ministry of Health and PMPB have been claiming through a press statement in the local media that the drugs under the kit system have been tested in the country as per requirement.

The statement comes after local drug manufacturers took Unicef and some SWAp donors to task on why Unicef was allowed to flout the country’s law that demands that every drug coming into the country has to be tested and certified by the PMPB.

The local drug manufacturers claimed Unicef was buying the emergency drugs from China and India which were taken straight to health centres.
But the statement signed by Ministry of Health spokesperson Henry Chimbali and PMPB acting registrar says the drugs under the kit system and all other drugs which are currently being distributed to government and Christian Hospitals Association of Malawi (Cham) facilities have been tested and certified to be of high quality, efficacious and safe.

Reads the statement: “As a matter of standard practice and following the policy, mandate and the responsibility entrusted in the in the office of the Pharmacy, Medicines and Poisons Board, all drugs that are used in the health facilities in the country are tested for quality before distribution.”

But contrary to the statement, at a meeting on February 23 2012 at DfID offices in Lilongwe, Unicef chief of operations Pamela Oganga said the drugs were not tested in Malawi because government was convinced that the companies supplying the drugs were pre-qualified and that the drugs went through rigorous quality assurance process.

“In view of that rigorous quality assurance process and pre-qualification of the companies supplying the drugs, government is convinced that the quality assurance is good,” she said.

Chimbali later said in an interview: “The consignment of the drugs that are currently being procured and distributed by our development partners have been tested for efficacy, safety and have been certified to be of high quality. When they arrive in the country, they are accompanied by a certificate of analysis showing all the tests done from Copenhagen.

“When they arrive in the country, the Pharmacy, Medicines and Poisons board review the certificates and currently are conducting post marketing surveillance to determine other elements of the safety and efficacy.

“It is, therefore, incorrect to say the drugs are not tested. These are the laid down processes that are currently being followed. This is done to most of the drugs and it is not unique to the current kit system. We have all the documentation and we can make it public for people to see.”