“It takes years to build a reputation, however one mistake can erase those gains”.
Death of Children in Gambia and Indonesia in September and October 2022, after consuming the cough syrups put the pharmacy industry in a major shock and jeopardized the manufacturing and sales of cough syrups. The cough syrups came under the scanner for containing Ethylene glycol and Diethylene glycol which are deadly if ingested. Presently, the company manufacturing these cough syrups have halted the production pending an investigation. So, what exactly happened here?
INCIDENT SUMMARY
Ethylene glycol and diethylene glycol are alcoholic compounds having industrial applications like the manufacturing of paints, ink, and brake fluids. If these chemicals are ingested, then they can cause serious health problems like nausea, vomiting, diarrhoea and also can damage the kidney, liver and central nervous system.
In its findings, the World Health Organization (WHO) announced that cough syrups made with the aforesaid chemicals resulted in the deaths of dozens of children in Gambia. The children were impacted by kidney injuries due to the alleged consumption of cough syrup by WHO.
However, in the recent news Gambia's Medicines Control Agency, a national regulatory body, has not yet pinpointed the exact cause of the deaths. "We haven't concluded yet it is the medicine that caused it. A good number of kids died without taking any medications," Jallow told a news conference. "Other kids died, the medication that they took, we have tested them and they are good," he added.
The Gambia Medicines Control Agency is trying to establish exactly which medications, if any, each child took.
The alarm in Gambia was first raised in July when kidney problems started affecting children. However, there was no definitive reason established for this. Later it was established that patients below the age of 5 after the consumption of locally sold syrup fell ill after 3 to 5 days. Read about the news here.
Meanwhile, Indonesia has also recorded a spike in child deaths from acute kidney injury in recent months and is investigating paracetamol syrups as a possible cause. However, it has prohibited sale of all liquid medicines and syrup following kidney injuries and the deaths of nearly 100 children under the age of 6.
“Quality is more important than quantity. One home run is much better than two doubles.” – Steve Jobs
HOW TO IMPROVE DRUG QUALITY CONTROL
“Quality means doing it right when no one is looking” – Henry Ford
A substandard drug basically is one that does not do what is said on the box. Basically, it may have an active ingredient less than 90-95%, the drug may not dissolve thus not releasing the active ingredient in the patient’s body or may contain impurities.
The laws treat spurious drugs and adulterated drugs more seriously like spurious drugs are basically one drug that masquerades as another drug and adulterated drug basically contains toxins.
The guidelines suggest that only administrative actions be taken by the state drug regulator which involves the suspension of license. If the company still does not course correct, only then can the regulator move to punish them in a court of law and the regulator should be able to prove gross negligence or criminal intent before deciding to prosecute.
Proving gross negligence or criminal intent could be difficult and normally legal processes take time to materialize which delays action on non-compliant companies.
So how to address this problem?
SOLUTIONS
“If you define the problem correctly, you almost have the solution.” - Steve Jobs
The Government bodies need to invest a lot more in ensuring that stricter action is to be taken to ensure compliance by pharma companies with quality standards.
Inspection by state and central agencies is important in ensuring compliance.
Getting ISO certified should not be sufficient criteria for companies, but regular checks is critical in ensuring quality.
Governments should invest much more money in giving drug companies incentives so that they do not compromise on quality and their costs don’t escalate.
Drug Consultative Committee guidelines must be more in the favor of the consumer than the manufacturers.
CONCLUSION
Finally, this incident has sent shockwaves across the pharma industry and among consumers since cough syrup is a must in every household. Seeing small children dying to the cough syrup is disheartening and governments across the world must realize the importance of maintaining quality standards for their products and how even a small lapse could escalate situations. Image source here.
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