Tanzanian Association Oslo

Sunday, November 04, 2007

Fake medicines pose big threat.

2007-11-04 09:35:36
By Peter Mwangu.

Jacob Hassan was diagnosed with malaria. The medic prescribed three tablets of Metakelfin to be taken at once and three others after a week. Jacob lives at Mbagala Kibondemaji on the outskirts of Dar es Salaam City.

As the medical facility had ran out of the tablets then, the patient decided to purchase the dose from a pharmacy in the vicinity. Little did he know that the purported medicine he had bought was actually paracetamol.

The malaria persisted. Ramadhani Daniel, who stays in Kibaha, Coast region, was another patient found with dry cough and was directed to take two capsules of ampicillin three times a day for five days. He proceeded to buy the medicine from a pharmacy at Mbezi where he works.

The cough did not subside even after taking the drug for the stated period. It was found later that the capsules did not contain ampicillin but potato starch. The health of both patients was put to great risk.

COUNTERFEIT MEDICINES IN TANZANIA

In August 1999, fake Metakelfin labeled as a genuine product from the original manufacturer, Pharmacia and Upjohn, was found in circulation in some pharmacies in the country.

Laboratory analysis confirmed that the counterfeit Metakelfin actually contained paracetamol and the public was alerted. In May 2000, counterfeit Ampicillin capsules (250mg) were found circulating in some retail pharmacies.

Laboratory analysis confirmed the capsules contained potato starch. In June 2001, expired Chloroquine Injection (from an unregistered Indian company) was relabeled as Quinine Dihydrochloride Injection 600mg/2ml from a company in Cyprus.

In January 2005, fake Gentrisone Cream (a product of Shin Poong, South Korea) was reported. In this case, the active ingredient was replaced with hand and body lotion, and again the public was alerted as well as withdrawing the product from the market.

EXPERIENCE OF FOOD AND DRUGS AUTHORITY

The Tanzania Food and Drugs Authority is worried and suspects that counterfeit and substandard medicines are in circulation alongside approved quality medicines, posing a serious public health problem.

A TFDA official says: This is a problem that affects both developed and developing countries. We have experienced a number of cases, and we have taken a number of steps to address these challenges, although more needs to be done.

Adds the official: Counterfeits contain arbitrary and unpredictable compositions that can be dangerous to the unsuspecting patients.

Some of the counterfeits are without active ingredients, while others might contain active ingredients but wrong in amount or quality.

Counterfeiting is a vice that threatens everybody, including manufacturers, importers, distributors, drug inspectors, dispensers, policemen, customs officers, judges, advocates, their families and friends! It undermines the credibility of health and pharmaceutical supply systems.

The World Health Organization estimates the global pharmaceutical market size at US$ 500bn (WHO, 2006) with counterfeit medicines accounting for 10 percent of that.

ROBLEMS IN COMBATING FAKES

Experts contend that Tanzania faces weak enforcement capacities because of inadequate number of inspectors.

It also lacks appropriate knowledge, skills and experience to detect, confiscate or investigate suspects of counterfeit medicines.

Low incentives for law enforcers who must confront unscrupulous dealers and little cooperation between stakeholders facilitate escape of detection, arrest and penal sanctions, said one expert.

In the case of the counterfeit Metakelfin (1999) and ampicillin (2000) the manufacturers were not taken to task although the courts ordered the closure of the pharmacies that sold the fake drugs.

Weak legislation can facilitate counterfeit trade. The former drug law in Tanzania, the Pharmaceuticals and Poisons Act, 1978; provided for a fine of not more than US$ 4! The current