Medicines agency on spot over fake drugs

By PETER ORENGO

Recent revealations that most drugs stocked by pharmacies and State-run health facilities are fake have heightened anxiety among Kenyans already assailed by myriad other counterfeit commodities.

Government representatives, who appeared before Parliament’s Departmental Committee on Health, confessed that many drugs in the market do not meet the quality standards.

The two State agencies mandated with vetting quality of drugs in the country, Efficiency Monitoring Unit (EMU) and National Quality Control Laboratory (NQCL), admitted that counterfeit drugs have found their way into the market because the regulating body had allowed them to.

The shocking disclosure came in the wake of reports that various drugs in pharmacies had failed the quality analysis test.

Safety tests

The committee heard that the Pharmacy and Poisons Board (PPB), which is mandated to ensure that only medicines that meet the established standards are sold in the country, has been allowing the registration of drugs even after they failed safety tests at NQCL.

Some of the drugs fingered include generics of popular antibiotics such as fluxate, penicillin and amoxicillin, which are used in the treatment of a wide range of infections among them pneumonia and common cold. The drugs are said to have originated from India, China, Pakistan, Egypt and Nigeria, with some manufactured locally.

The damning indictment of the board is contained in an audit by the Efficiency Monitoring Unit, ordered to investigate the prevalence of counterfeits in the country by former Medical Services Ministry Permanent Secretary James ole Kiyiapi.

Although the reported was submitted to various relevant departments, including PPB, in March, nothing has been done. Prof Kiyiapi has since been transferred to another Ministry.

The PPB Act stipulates that any pharmaceutical products imported into the country must be registered with the board after successful analytical tests by the NQCL, and the site of manufacture.

"A comparison tests on drug analysis tests maintained by NQCL and drug registration section of PPB revealed that the PPB registered some drugs despite these drugs failing analytical tests," NGCL Director Hezekiel Chepkwony told the MPs.

The tests are aimed at ensuring that the medicines are soluble, contain the stated active ingredients, are of the stipulated hardness and don’t bear signs of breakages.

Pfizer, a global pharmaceutical firm with a global health care portfolio, first raised the red flag over massive manufacture of counterfeit products bearing its name in the country.

It confirmed that it had found counterfeits of about 50 of its medicine in markets around the world.

They included antimalarial, antibiotics, tablets for lowering cholesterol, Alzheimer medicine, pain killers and those used for treating erectile dysfunction, which are in circulation in over 100 countries, including Kenya. "While medicine counterfeiting remains a significant safety challenge for the healthcare community, partnership between the public and the private sector must be maintained," said Steve Allen, senior director of Pfizer.

The Government agencies cited anomalies during the importation process included the ports of entry. Kilindini Port, Jomo Kenyatta International Airport and Eldoret Airport were said to be the preferred entry routes of counterfeits with the latter said to be the most compromised access point.

"According to data availed to us by KRA and several correspondents from the pharmaceutical inspectors based at Eldoret Airport, there were no declarations of pharmaceutical products in the import documents for the periods reviewed, although cases of confiscated drugs were recorded," said Dr Chepkwony.

Graft and ineptitude

"We are shocked by what we have heard today because it is clear that corruption, ineptitude and inefficiency are rife at the PPB. This should not be happening to Kenyans," said the Chairman of the House Committee on Health, Mr Robert Monda.

According to the World Health Organisation, a medicinal product that fails to meet any or more of the qualities is not only a waste of money to the user but could lead to resistance, poisoning and even death.

"A poor quality medicine may contain toxic substances that have been unintentionally added. A medicine that contains little or none of the claimed ingredient will not have the intended therapeutic effect," says the WHO.

The auditors said they looked at data on drug analysis by the NQLC between 2007 and last year, and that of drugs registered by the board during the same period.

Last year, a report by the International Policy Network and sponsored by Imani Centre for Policy and Education, lay bare the burgeoning problem of counterfeit and substandard drugs, which it said almost constitutes a third of the drug supply in certain African countries.

These dodgy drugs result in unnecessary death and increased levels of drug resistance. The report further affirmed that nearly half the drugs sold in Kenya, Ghana, Nigeria, Angola, Burundi, and the Congo are substandard. It also said that about two thirds of artesunate (anti-malaria) drugs in Laos, Myanmar Cambodia and Vietnam contain insufficient active ingredient.

Most fake drugs are said to originate from China and India, which are leading exporters to Kenya’s private and public health sector.

Current attempts to deal with the problem through tougher regulation and criminal penalties have not addressed the causes of counterfeiting. Even worse, many countries are said to have corrupt regulatory and legal systems that are easily compromised by counterfeiters, so additional rules will only increase corruption.

"Governments exacerbate the problem by making legitimate drugs more expensive through taxes and tariffs. What is needed are effective mechanisms to enable purchasers of drugs to be assured that what they are buying is the real thing," said Dr Allen of Pfizer.

The global trade in fake medicines is said to vast and growing. It results in millions of people unwittingly consuming cement, talcum powder, sawdust, paint and an array of other toxic or inert substances.

Worsening illness

It also thwarts efforts to cure disease and worsens illness. And worst of all, it results in the emergence of drug resistant strains of diseases ranging from Aids and malaria to tuberculosis and bird flu

In wealthy countries, the discussion of fake medicines tends to focus on dangerous counterfeits imported into domestic markets (and state-run health services). World Health Organisation previously adopted resolutions aimed at addressing all kinds of poor quality drugs.

In 1988, a resolution sought "to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, counterfeited or substandard pharmaceutical preparations." Again, in 1994, another resolution called for action to ensure that available drugs are of good quality.