[e-drug] 10% of Kenyan Drugs Sub-Standard - Study

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E-DRUG: 10% of Kenyan Drugs Sub-Standard - Study 
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[another worrying report from Africa about poor quality essential drugs; 
the original article was published in the Est Afr Med J (see http://www.ajol.info/journal_index.php?jid=53&tran=0&ab=0]
Any Kenyan E-drugger who wants to comment on the response by the Pharmacy & Poisons Board? WB]

10% of Kenyan Drugs Sub-Standard - Study 

The East African (Nairobi) 
NEWS
August 16, 2004 
Posted to the web August 18, 2004 

By Dagi Kimani, Special Correspondent
Nairobi 

A WORRYING percentage of medicines manufactured by Kenya's pharmaceutical industry - the largest in East Africa - are substandard, a new study has established. 

Analysts say that the conclusion of the study could have far-reaching implications for "made in Kenya" drugs, which are exported widely in the East and Central Africa regions. Three years ago, Uganda suspended the importation of one popular anti-malarial drug made in Kenya on grounds that it was wrongly formulated. 

According to the study, nearly 10 per cent of locally manufactured drugs sampled were wrongly formulated, with quantities of the active ingredient lower or higher than the acceptable levels. Nearly 20 per cent of the drugs did not dissolve as expected, while half were of the wrong weight. 

"Although local pharmaceutical industries have adopted good manufacturing practices leading to many good quality products, these manufacturing practices are not comprehensive and measures need to be taken to continue improving them," a report on the study published in the latest issue of the East African Medical Journal says. "An overall 76 per cent compliance to quality specification shows that there is still room for improvement." 

The study was conducted by researchers from the Kenya Medical Research Institute (Kemri) and the University of Nairobi, led by Dr Jennifer Orwa. 

The team's findings come hot on the heels of media reports that the Ministry of Health was withdrawing painkillers worth millions of shillings following complaints by doctors in various hospitals that the drugs were substandard. Last week, top officials at the National Quality Control Laboratory and the Pharmacy and Poisons Board (PPB) declined to comment, saying that they had not seen the journal's report. 

According to the study, one key problem with many Kenyan pharmaceutical firms is the failure to engage qualified personnel in proportion to their product range, leading to poorer supervision of production lines and quality control. Most of the indigenous firms surveyed, the report says, employ just a handful of pharmacists, who are expected to oversee the production of medicines running into more than 100 types. 

Half of all products from one unnamed Industrial Area-based factory with a product range of 290 products and employing just six pharmacists were found to be substandard, as were products from another firm with a product range exceeding 100 but employing just five pharmacists. 

In contrast, all medicines from a subsidiary of a multinational pharmaceutical company employing 16 pharmacists to manufacture a 30-product range were found to comply with all tested quality standards. 

"Inadequacy of appropriate qualified personnel may be a contributing factor to poor compliance to GMP in the industry," the EAMJ report says. "Industries that engaged in the manufacture of more than 100 drug products and had few pharmacists showed higher failure rates compared with those producing a smaller range of products but that have engaged more pharmacists." 

According to the PPB the Ministry of Health's regulatory arm, there are about 40 registered drug manufacturers in the country, including subsidiaries of multinationals. 

Players in the industry generally repackage already formulated medicines, or manufacture medicines from imported raw materials. The bulk of the materials are imported from India, Pakistan and China. Imported finished products supply nearly 50 per cent of the national pharmaceutical demand, with such products as vaccines being fully imported. 

Since 1982, the Kenya government has been making efforts to maintain the quality assurance of locally-manufactured products through legislation and limited market surveillance. Critics, however, say that the efforts by the government to regulate the industry have perennially been hamstrung by the failure to employ adequate numbers of qualified surveillance staff, with the number of drug inspectors remaining at less than 20 for the past decade. 

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