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the World Health Organisation (WHO) issued an alert on Wednesday against four cough and cold syrups made by Indian- based Maiden Pharmaceutical, warning that they might be linked to the deaths of 66 minor children in the West African nation Gambia. Reacting to the development, former Indian Medical Association (IMA) president JA Jayalal termed the incident ‘shocking’.
In a telephonic conversation with Republic Media Network on Thursday, former (IMA) president JA Jayalal said, “We are shocked to hear this. India is becoming the portal of the pharmaceutical industry for supplying medicines to various countries and the industry is growing in many other avenues. At this moment, such a bad incident is definitely a great shock to us.”
Speaking about the manufacturing of drugs, JA Jayalal said, “The problem in India is that the country doesn’t have strict control over the manufacturing of pharmaceuticals. Without the adequate manufacturing system, they are producing drugs and supplying in foreign countries.”
“Companies are producing drugs that do not comply with the policy control, and not going through particular certification. By some means, they are able to send these medicines to foreign countries and that is creating the problem. The majority of the MNCs are playing a direct role in the manufacturing of drugs because only MNCs are able to make drugs of that standard and get into the market in India and abroad,” the former IMA president said.
JA Jayalal further mentioned that this is a great misfortune for Indian citizens. “This is an open opportunity for the Indian government to act strictly on all the manufacturing companies and ensure that good manufacturing practice is followed by all companies to avoid similar situations in the future.”
“I hope all drug manufacturing companies in India will undergo strict compliance with rules and regulations. If not so, it will entirely affect the progress of the pharmaceutical industry,” he added.
The World Health Organization issued an alert for four “contaminated” medicines manufactured by an Indian pharmaceutical company that has been “potentially linked” with acute kidney injuries and 66 deaths among children in the Gambia.
According to World Health Organisation (WHO), the medicines made by New Delhi-based Maiden Pharmaceuticals Limited, which have been largely used for paediatric use, are believed to contain chemicals that are toxic and potentially fatal.
Notably, the WHO Medical Product Alert said the four products reported are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup, all manufactured by Maiden Pharmaceuticals Limited.
According to a PTI report, laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
Meanwhile, outlining the risks associated with the products, WHO said that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
“Toxic effects can include abdominal pain, vomiting, diarrhea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” it said.
"All batches of these products should be considered unsafe until they can be analyzed by the relevant National Regulatory Authorities. The substandard products referenced in this alert are unsafe and their use, especially in children, may result in serious injury or death," it added.