Pharmaceutical Manufacturers demand Compensation

Accra, April 27, GNA- The local Pharmaceutical Manufacturing Industry in Ghana on Thursday asked for compensation to be paid to them for the lost incurred after the withdrawal of the 200mg and 600mg of the Artesunate-Amodiaquine.

According to them, the companies that were selected to manufacture the malaria drug incurred a direct loss of two million dollars for the equipment, raw materials and packing material. Mr Kofi Nsiah, who represented the local manufacturers, said the pronouncement of the withdrawal by the National Malaria Control Programme (NMCP) had made the public to loose faith in the locally manufactured pharmaceutical products.

"The compensation will support the investment lost and will enable us to reinvest when a revised malaria drug policy is finally put in place."

The NMCP some few months ago withdrew 200mg and 600mg of Artesuante-Amodiaquine alleged to be produced by the local manufacturers from the market based on complaints of the adverse effects it had on patients because the strength was too strong. Mr. Nsiah was speaking at Pharmaceutical Society of Ghana symposium to mark this year's Africa Malaria Day, which fell on April 25, under the theme: "Get your ACT Together. Universal Access to Effective Malaria Treatment is a Human Right,"

The focus on this year's Africa Malaria day was to ensure that all malaria patients had access to effective treatment without hindrance. Mr Nsiah, who is also the Executive Director of Kinapharma Pharmaceuticals said their equipment invested for the production were lying idle, packing materials on one single dose were sitting in their warehouses wasting away, stocked already sold were being returned for cash and finished products were also pilled up awaiting further directives.

Mr Nsiah giving the background of the issue said three pharmaceutical manufacturing companies, Ernest Chemist, Kinapharma and Dalmas were contacted in 2002 to discuss the change from Chloroquine to Artesuante-Amodiaquine as the first line treatment for malaria. He explained that a stakeholders meeting agreed for the implementation of the choice of drug on January 1, using a World Health Organisation (WHO) recommended dosage. The stakeholders' meeting was attended by Noguchi Memorial Research Institute, Food and Drugs Board (FDB), NMCP and the local manufacturers.

He said to improve patient compliance, a combi-pack formulation was adopted and manufacturers were asked to produce samples for FDB to test for physical and chemical parameters, whilst the Ministry of Health was to look for funds for the safety and toxicity studies for Noguchi to carry out studies before the products were put on the market. Mr Nsiah explained that because funds to conduct the safety and toxicity were not forthcoming and they had a deadline to meet, FDB gave conditional registration to the three companies to put the drug on the market, while they waited for tests to be carried out. "Late 2005, NMCP changed the dosage from daily dose regimen to single divided daily dose regimen and this was when patients had started reacting adversely."

Ghana Health Service started making some pronouncements that some local manufacturers had put some products on the market that were creating problem but meanwhile, they had also imported a one daily divided dose in addition to what were produced locally. "Our question now is if the quality of the local manufacturers were not good, why the withdrawal of only 200mg and 600mg, have safety trials been done on the imported Artesunate-Amodiaquine to show that there is no adverse reaction, can we tell of any country in the world whose Artesuante-Amodiaquine is given in divided doses and has WHO confirmed the use of divided doses?

Mr Nsiah said NMCP should come out with a new anti malaria drug policy and must give the specifications of all drugs to be used in policy regarding the strength required as well as the packaging style. "Specify daily dose, whether it is one daily dose or divided doses, FDB should also specify the registration requirements or local manufacturers and NMCP must have their communication strategy drawn up and reviewed by all parties prior to the implementation of the new revised policy", he added.

Mr. Samuel Owusu-Agyei, a Deputy Minister of Health said a committee had been set up after the reports on the adverse effects of some of the brands of the products.

He said the Ministry would study the report which would be submitted in the next two weeks and implement the recommendations to ensure smooth implementation of the policy. He noted that malaria remained the number one cause of death of children under five and it killed 1.1 million people in Africa every year.

"In Africa, it is estimated that a child dies of malaria in every three minutes and we can imagine the number of children that would be lost in a day".

He challenged the PHSG to critically examine the policy and make suggestions to help improve its implementation, adding, "it is indeed regrettable that government should spend much of the country's scares resources for the treatment of a disease that is preventable". Mr Owusu-Agyei urged the NMCP and the PHSG to collaborate with the Ghana Education Service to educate school children to cultivate the habit of environmental hygiene. 27 April 06