Safety of Medicines - urgent action needed
According to the WHO alert, the four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. Attached images.
"To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," the alert said, adding that laboratory analysis of samples of the products "confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants."
Those substances are toxic to humans and can be fatal, it said, adding that the toxic effect "can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death."
We really must get Govt to act on this so atleast from a DCGI standpoint there arent loop holes and a perception building that Indian pharma is not trust worthy.
Also we need to know what of these toxic syrups have been sold within India rural or urban more
"To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," the alert said, adding that laboratory analysis of samples of the products "confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants."
Those substances are toxic to humans and can be fatal, it said, adding that the toxic effect "can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death."
We really must get Govt to act on this so atleast from a DCGI standpoint there arent loop holes and a perception building that Indian pharma is not trust worthy.
Also we need to know what of these toxic syrups have been sold within India rural or urban more
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Premature scare mongering and mud slinging. The contents of every drug are revealed on the container and carton, which are generally in a language readable by WHO. If any medicine, when tested, should reasonably confirm to that contents and any testing authority finds to the contrary, should divulge the results to both the manufacturer and regulatory authority of the country concerned instead of premature speculation. This is an attempt to defame the Indian Pharmaceutical Industry, over which most of the world depends. WHO has only said this so far - “ The manufacturer of these products “to date, has not provided guarantees to WHO on the safety and quality of these products” It’s imprudent for us Indians to make a mountain out of this mischievous and perhaps motivated action by WHO. more
Oct 11
Doubt cast on our controlling authorities, the DCGI as well, who also had the responsibility for checking the drug consignment being delivered to the African nation. How did the Haryana based company Maiden Pharmaceuticals continue having a license to manufacture the drug! Can't rely entirely upon the manufacturer, when some products cross our borders. None of the company's employees, or offices after the above happening, was contactable. Despite all the celebratory messages about Make in India, touted too as being the pharmacy of the world, this incident draws and directs our attention towards how much India's commitment towards safety of medicine is wrong. more
Oct 08
Heart rending! Instead of glycerin, the cough syrup contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants, which did the damage! Paediatric medicines must be milder than those taken by adults, while in this case such was the drugs standard! Glycerin, being hygroscopic substance, many a times used for diluting in oral medicines which must be made milder, since they pass the same passage through the human body as food. Simple logic. Government's safeguards should have been in place. Shocking! more
Oct 07
looks like our drugs controller dept is taking a nap when these kinds of activities are happening under their nose and going un reported.How did they get approval from them very surprising.There will be lot of these kind of drugs in circulation without the knowledge of our DCI.It is high time that medical shops should be made to keep medicines which are approved by DCI and also need to be seen which doctor has prescribed these syrups.Looks like they got percentage commission for prescribing these syrups.DCI need to immediately ask all medical shops to destroy stocks what they have of the above medicines.There is lot of activities which they have to initiate immediately and hope they wake up from their nap. more
Oct 06
Sri. Nishat Khan, "a perception building that Indian pharma is not trust worthy"... Unfortunately, to me it not a "perception", it is reality. more
Oct 06
