Local pharmacists object to the simplification of the registration procedure for imported drugs, reports Reem Leila A decree issued by Minister of Health and Population Hatem El-Gabali exempting foreign drugs from the first stage of the registration process necessary before they are allowed into the Egyptian market -- provided they have already been approved by the US Food and Drug Administration or its European equivalent -- has sparked protests from the Egyptian Pharmacists' Syndicate (EPS). El-Sawy Habib, a member of the National Specialised Councils, claims the decree, which he says exempts already approved drugs from bio-availability testing, will harm the local drug industry. Imported and finished drugs, he argues, can be affected by shipment and transportation conditions and "exempting these drugs from bio- availability testing could have disastrous health consequences". EPS Secretary-General Mahmoud Abdel-Maqsoud agrees. Imported drugs are manufactured in different climates to that of Egypt and movement from one climate to another can have a negative impact on the active components' efficacy. "The minister is effectively discriminating against locally produced medicines in favour of imported drugs," claims Abdel-Maqsoud. Health Ministry spokesman Abdel-Rahman Shahin dismisses such complaints as groundless. The drug registration system in Egypt, he points out, had become convoluted and overly bureaucratic. Until recently foreign drugs could wait up to five years before being approved for sale in Egypt. The system now takes only six months, and the minister's latest decree is an attempt to further streamline the regulations. Any drug, whether imported or locally produced, Shahin stresses, must pass through several stages before being offered in the Egyptian market. The first phase is registration at the National Organisation for Drug Control and Research (NODCAR) and it is this, says Shahin, from which foreign drugs are now exempted. "It is an administrative stage, drugs still have to pass through two more phases before being released onto the market." Bio-availability tests, he further points out, are not applied to original medicines but on generic ones. And because such testing is ongoing -- samples are tested randomly on an annual basis until the drug reaches its expiry date -- it is not the case that foreign drugs are exempted from such testing. "We have discussed these points with the EPS yet still they are not convinced," says Shahin. The local pharmaceutical industry in Egypt is worth $1.8 billion annually. It is expected to grow by 18 per cent this year and to reach $3 billion by 2015. Egypt is the largest producer and consumer of pharmaceuticals in the Middle East despite relatively low per capita income. Some 7,600 drugs are manufactured locally, meeting 93 per cent of market needs. The remaining seven per cent are imported. Egypt exports only $150 million worth of its local production, though the ministry hopes to increase that figure more than six-fold within five years.
