War On Counterfeit Drugs Still On

Gasirigwa Sengiyumva | 05 Jul 2010
Tanzania Daily News
Dar Es Salaam — The issue of substandard and counterfeit medicines remain a huge problem, not only to sub- Saharan Africa as a whole but also to this country in particular. This is an appalling situation that proves fatal for some of the world's poorest, most vulnerable people.

The severity of the situation is clear and has called for action among relevant authorities. This year, in a survey done by the US Pharmacopeia found out the 44 per cent of anti-malaria medicines from Senegal failed quality tests. In Uganda, the failure rate was 30 per cent and in Madagascar 26 per cent.

In a survey at some Dar es Salaam clinics by Julian Harris, a Research Fellow at International Policy Network based in London, there are interesting findings. In the report, she says she visited small clinics in the city, which are providing excellent service to communities that were until recently neglected by the government health system.

But, she says, "Such clinics, both public and private are in unenviable position of having to source affordable medicines while avoiding the sea of sub-standard and counterfeit offerings."

Studies show that throughout the continent, failure rates are frequently observed at around or over one third of drugs. A peer reviewed 2008 study put the rates in Ghana, Kenya, Nigeria and Rwanda respectively at 35, 38, 32 and 33 per cent. In this country, 32 per cent were sub-standard.

Tanzania Foods and Drugs Authority (TFDA) is a regulatory body under the Ministry of Health and Social Welfare, which is responsible for controlling the quality and safety of food, drugs, cosmetics and medical devices.

Last year's implementation report from the authority show the continuity of inspection follow ups that involved law enforcers at the organisation headquarters, district council offices, ministries, departments and other institutions at different occasions.

During last two years, 1,550 food building houses were inspected of which 1,274 were ok and 82 per cent of them met the required standards and were awarded processing and selling permits.

Over 5,000 buildings that deal with medicines and cosmetics products in the country were inspected, of which 834 (about 17 per cent) met the required standards.

According to the authority, areas that showed much weakness were health services centres such as dispensaries, in which a large amount of expired medicines were found. Also discovered was the unsatisfactory medical storage facilities and laxity in adhering to usage instructions on medicines that contain extra 'drug' content.

The authority in conjunction with the International Police (INTERPOL), local police force, the Fair Competition Commission (FCC), Tanzania Revenue Authority (TRA) the Medical Stores Department (MSD), president's office and the Bureau of Standards (TBS) conducted a special inspection campaign branded 'Operation Mamba 1' in order to identify counterfeit drugs among other groups that include malaria medicines, pain killers, anti-biotics and Viagra.

Dar es Salaam, Mwanza, Arusha and Mbeya regions were major areas of this operation. Of five types of medicines that were thought to be counterfeit and tested in laboratories, 'Ketoconazole pills' were fake. In the past two years, the authority has foreseen foods, drugs and cosmetics products destroyed because of not meeting the required quality and safety standards. These products are worth more than 1.2 bn/-.

Counterfeit products are imitations or substitutes of another product likely to deceive or bear upon its label or container, the name of another product so as to reveal its true character or the product that has been substituted wholly or in part by another substance to be a product of manufacturer of whom it is not truly product.

They are deliberately and fraudulently mislabelled products with respect to identity or source. According to experts, they may include products with correct ingredients but fake packaging, with wrong ingredients, without active ingredients or with insufficient active ingredients.

This is a global problem and the World Health Organisation (WHO) estimates that counterfeit medicines account for approximately 10 per cent of the global pharmaceutical market, which is estimated at about US dollar 500 billion.

Security sources say this is a lucrative business that attracts scrupulous dealers to engage with advancement in manufacturing and labelling technology, long distribution channels and free trade zones.

It is enhanced with globalisation, which allows free movement of goods and weak enforcement capacity; meaning inadequate knowledge, skills and experience to detect and investigate counterfeit products and of course inadequate co-operation among stakeholders.

TFDA officials available at the Dar es Salaam International Trade Fair (DITF) say counterfeit products can adversely affect public health, which may lead to prolonged illnesses and death. It also can hinder the development of local industries that are manufacturing genuine products, among many.

But how can one identify a counterfeit product? The authority agrees that it's one of the biggest challenges due to the resemblance with the genuine products.

However, there are some characteristics and features that can help consumers to suspect fake or sub-standard products, for example colour, texture and taste of the product and its packaging material, seal and labelling.

To ensure that the general public gets quality and safety products, several initiatives are undertaken including; evaluation and registration prior market authorization, registration and issuance of permits for manufacturing and distribution of regulated products.

"We also perform laboratory analysis of products prior to registration and circulation in the market," says a quality control officer who says he isn't an official spokesperson. He adds that while the products enter the market are randomly sampled and analysed to assess their quality, efficacy and safety.

"There is frequent inspection and surveillance at main entrance points such as ports, distribution channels and selling outlets, among others," he tells.