Alata Samina: Soap or Drug?

By Jean Lukaz MIH

Reviews of certain local products by the Consumer Partnership (The COP) on the Ghanaian markets reveal a certain level of uncertainty regarding their classifications. This is particularly the case of plant-based products that are sometimes erroneously referred to as herbal products but actually have no herbal basis for that description after they lose their herbal properties after being processed. It is even more complicated when the labelling of such products contain claims as to their potency in treating certain medical conditions.

Alata samina has been the worst offender so far with many that have been exported to the US rejected and returned on the basis that Alata Samina is a drug and not soap based on the claims on the labels, and therefore the need to certify them in Ghana as drugs.

Even some of the ‘improved’ versions of Alata Samina have the pharmaceutical plus sign on the labels and many are questionning to what extent some of these claims can be considered deceptive, given the local acceptance of Alata Samina as having medicinal properties.

Expert opinion from the Ghana Standards Board (GSB) indicate that Alata Samina can neither be referred to as ‘Herbal Soap’ as the initial herbal ingredients lose their herbal properties after the processing and the final product is just ordinary local soap that can neither be considered medicinal by technical standards, otherwise it has to be proven so and certified as a drug by the Food and Drugs Board (FDB) too.

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Stop Confusing Ghanaian Consumers!

Consumer alerts issued recently by the Food and Drugs Board (FDB) in respect of some identified fake medicines in the marketplace has been deemed inappropriate and confusing by the Consumer Partnership (The COP), a consumer protection organization in Ghana.

With the majority of Ghanaian consumers being illiterate and the literate folks not savvy enough to read the labels on products and moreso expiry dates and batch codes, the FDB alert on March 12, 2010, cited the names of the products as Cipro-Dor (Ciprofloxacin Hydrochloride) and Clavu-Dor (Amoxicilin 500mg and Cluvulanic Acid 125mg) the name of the manufacturers. There were no images of the products empahsizing the details Ghanaian consumers should be looking out for when purchasing such products. Worst of all, mobile phone numbers were cited as hotlines.

Four days later, on March 16, 2010, the FDB comes out to clarify the previous alert that it was only related to a particular batch and not the entire range of the mentioned brands believing in the assumption that Ghanaian consumers understand batch coding. The Pharmacy Council has an obligation of rather alerting their members on pulling off the fake drugs off their shelves so they do not reach the hands of poor Ghanaian consumers who trust that pharmacists will only sell them wholesome medicines.

The work of regulatory agencies such as that of the FDB require huge budgets for Consumer Education (CE) and Product Alerts and government must take cognisance of this when approving their budgets.
The Consumer Partnership believes that consumer alerts of such nature should be accompanied by full colour photographs of the products in question on the front pages of national newspapers. It is an apology to have regulatory agencies such as the FDB to put out such alerts and cite expensive mobile phone numbers as hotlines instead of toll-free numbers and set up control points in the marketplace. The pharmacy council must have a self-regulatory mechanism for following up on such alerts.

In a related development, when the Ghana Standards Board (GSB) issued an alert on Tuesday, October 27 2009, on the presence of some brands of tomato paste on the Ghanaian market which contain starch and sugar but are branded as ‘Pure Tomato Paste’ in contravention to the GSB Standard for Tomato Paste, there ensued a week-long rebuttal by FDB and an institutional debate between the FDB and GSB on their mandates instead of embarking on consumer education regarding the brands on the market that were unsafe or did not meet the GSB Standard.

According to Jean Lukaz, a Consumer Advocate, consumers in Ghana are being taken for granted by the very institutions that have the mandate to protect them from unscrupulous business people in the marketplace. This, he said, is the result of very little, ineffective, misguided or no consumer education being carried out by these institutions. When consumer forums are organised by some of these institutions, they are elitist in nature and do not give the ordinary poor consumer a voice given the duration, atmosphere, language and location restrictions, he added.

CONSUMER ALERT!!!: Stamina-Rx Dietary Supplement Recalled Nationwide

Unapproved Ingredient Present in Supplement

Food and Drug Administration (FDA) and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all product sold under the name Stamina-Rx. FDA lab analysis found that the product contained the undeclared ingredient − benzamidenafil. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that are FDA-approved for the treatment of erectile dysfunction (ED).

Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

Stamina-Rx is sold predominantly in health food and drug stores nationwide. Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA's MedWatch Adverse Event Reporting program online at www.fda.gov/MedWatch/report.htm or by phone 1-800-FDA-1088 or by returning the postage paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20853-9787 or fax 1-800-FDA-0178.

China Pushes Fake "Indian" Drugs in Africa

10 June 2009; http://www.safemedicines.org/

Nigeria's food and drug watchdog, the National Food and Drug Administration and Control (NAFDAC), has seized Chinese-made fake generic anti-malarial drugs with the label 'Made in India'.

India had long suspected that many Chinese firms conspiring with Nigerian drug traders, were dumping fake drugs in Nigeria, to be sold locally as well as in some other African countries like West Africa, South Africa, Ghana and the Ivory Coast.

After being alerted by the Indian high commissioner in the Nigerian capital Abuja, the Indian government has lodged a strong protest with the Chinese foreign trade ministry.

The Indian high commission in Nigeria had been aware for some time that Chinese companies were pushing fake drugs with the 'Made in India' tag since Indian generic drugs are the preferred choice of importers in Nigeria.

Indian high commissioner Mahesh Sachdev has also taken up the issue with the director-general of NAFDAC Dr Paul Orhii, who has assured that his administration would do its best to stop the fake drugs from entering Nigeria.

India is oncerned that these fake drugs manufactured in China and sold in African nations with the 'Made in India' tag could not only harm the country's reputation but also eat into the share of Indian drugs in the generic drug market in Africa.

The UK newspaper The Observer had also reported recently that fake Chinese drugs were flooding the UK market and Bian Zhenjia, China's deputy commissioner of the State Food and Drug Administration, said that it was wrong to say that China was a major exporter of fake drugs'

''I do not agree with what the foreign media has been saying. The Chinese government has always paid great attention to cracking down on fake drugs,'' Bian told a news conference in Beijing yesterday.

He however admitted that the problem could lie with some overseas companies having deals with illegal producers in China where foreign companies import chemicals from China and then use them to produce the drugs.

China has a flourishing but badly regulated pharmaceutical industry, with numerous underground factories and illegal manufacturers of spurious drugs thriving with little or no supervision at all.

In 2006, nearly 100 people in Panama are believed to have died after consuming toxic, mislabelled drugs in cough syrup from China.

Hundreds had also died due to allergic reactions caused by contaminants in the blood thinner heparin imported from China, which eventually led to the product being recalled in the US.

A diabetes drug linked to deaths in China, was pulled out after samples were found containing six times the normal amount of a chemical used to lower blood sugar.

The Chinese drug regulator had to recall many counterfeit and shoddy drugs and herbal medicines, including Chinese versions of Viagra in China itself.

Chinese, and now Indian, companies have been accused of selling fake drugs in Nigeria's $298-million pharmaceutical market, nearly 60 per cent of which comprises imports.

Although, the $298 figure looks small, it is attractive to fake drug manufacturers. According to a survey conducted in Nigeria in 2007, fake drugs make up for over 50 per cent of all drug sales in th country. The Pharmaceutical Society of Nigeria, puts thefigure of fake drugs circulating in the country at nearly 70 per cent.

The NAFDAC website shows that it has blacklisted more than 30 Indian and Chinese companies for exporting fake drugs into the country.

The Nigerian fake drug trade operates with mafia-like thoroughness and is run by wealthy businessmen with links to the underworld.

The director-general of NAFDAC is regarded as one of the most dangerous jobs in the world.

Nigerian minister of information, Dorothy "Dora" Akunyili, who was the previous director-general of NAFDAC had been fighting a relentless battle during her tenure with drug traders in Nigeria by publicly burning seized fake drugs and conducting massive raids with armed police battalion.

The wealthy fake drug lords struck back by burning down NAFDAC labs and buildings and even made an attempt to kill her. Akunyili narrowly escaped death when a bullet grazed her head after suspected assassins opened fire on her official car in 2003.

Nobody knows the way the Nigerian fake drug market operates as Akunyil does. A pharmacologist by profession, her diabetic sister, Vivian Edemobi , died in 1988 after being administered fake insulin for two years.

According to Akunyili, who is now the Nigerian minister of information, fake drug manufacturers have become so sophisticated, that even multinational drug companies find it difficult to say whether their own drugs in Nigeria are genuine or fakes.