By GATONYE GATHURA
Harmful cough medicines banned in India over the weekend are legally selling over-the-counter in Kenya despite many warnings by local medical experts.
India’s Ministry of Health and Family Welfare banned 322 medicines including several common cough syrup solutions.
The safety and effectiveness of cough syrups especially in combination formulations has been a controversial issue with most research warning they are not safe or effective especially for small children.
Most of the banned medicines including antibiotics are available in Kenya and mainly manufactured by Kenyan companies from raw materials imported from India.
Last year researchers from Moi University and Moi Teaching and Referral Hospital both of Eldoret warned that local drug companies were manufacturing highly harmful over-the-counter cough syrups targeted at infants.
Some of the medicines, the researchers said in their study published in the journal Plos One had up to four harmful ingredients in a single formulation.
“It is inappropriate that three or four ingredients which are individually harmful to children, can be combined in one formulation and administered freely to children, including infants,” the authors wrote.
The team of seven medical researchers led by Gabriel Kigen says all the harmful syrups were manufactured in Kenya, while the ingredients were imported, mainly from India.
The team had interrogated 260 mothers who take their children to the referral facility and 55 pharmacy attendants from Eldoret town. It had also collected samples of popular cough and cold syrups from local pharmacies.
Shockingly the team found most of the mothers were using these cough syrups on children some of them less than three months old.
“There was widespread use of the syrups in children, including infants, with 192 about 74 per cent of the mothers having used the identified syrups.”
Ninety per cent of these syrups were used on children less than two years including some about three months.
The other problem, the study reveled was that three quarters of the mothers were overdosing their children at double the recommended dose.
This was attributed to poor numeracy among many parents as well as ignorance or greed on the part of pharmacy attendants and drug manufacturers.
Sixty per cent of the pharmacy attendants were not aware the syrups contained ingredients harmful to children, especially when administered in combinations.
According to the attendants, the most important factors which influenced the sale of specific syrup were cost, duration in the market and the aggressiveness in marketing by the manufacturer.
“We were informed that some manufacturers provided incentives such as discounts and credit facilities to the outlets,” says the study.
The researchers describe the issue as mind-boggling and could not understand the rationale for the use of a combination of three ingredients with similar functions in one product. One product was found to contain four such ingredients.
Some of the eight products collected in the study did not carry warning labels barring their use in infants, despite existing knowledge that they are indeed harmful.
Kenya’s medical products regulatory authority, the Pharmacy and Poisons Board in their website indicate over the counter cough syrups are not recommended for infants. However this recommendation is not enforced.
It is thought local pharmaceutical manufacturers are stepping in to fill a void left by multinationals after many of developing countries restricted the use of cough syrups in children.
The position of the American Academy of Pediatrics has since 2008 been that the syrups do not work in children less than six years, and that their misuse could cause serious adverse effects.
Since then evidence has been piling up indicating that these drugs have no therapeutic value even in older children.
Last year a team of researchers at the Aga Khan University Hospital in Nairobi assessed the efficacy of cough medicines in 12 year-old-children. They compared this to a honey formulation and a placebo.
Reporting in the East African Medical Journal, Dr Adil Waris and his colleagues said honey was found to be most effective in relieving symptoms while medicines and placebo had no benefit.
Kigen and his team in Eldoret now want the Pharmacy and Poisons Board to revise its cough and cold medicines list in line with international recommendations and enforce this policy.
It should also discourage the production of syrups with multiple harmful ingredients which may have no therapeutic value or may be harmful.