The World Health Organization (WHO) issued an alert on Wednesday regarding 4 cough syrups made by India's pharmaceutical company. WHO said that these products do not meet the standards. They are not safe, especially for children, there is a risk of serious problems or death from their use.
The WHO said that 66 children in the Gambia have died due to deteriorating kidney conditions. Children may have died due to the use of these syrups. These products are currently only found in The Gambia.
The WHO said in the report that cough syrup contains such amounts of diethylene glycol and ethylene glycol that the reasons can be fatal to humans. 33 including children have lost their lives in India due to these compounds, but these compounds have not been banned.
WHO has issued a medical product alert. This is very serious not only for countries like the Gambia but also for India. If the matter is related to children, then the meaning of the alert becomes wider. There are many questions .. like the detailed report of WHO, the Indian company where they were produced, are these syrups being sold in India too, are they dangerous?
Company shuts down website: Soon after the alert was issued, Bhaskar interacted with medical experts and officials. It was learned that the company whose syrup is in question has closed the website so that people can not get much information.
The compounds mentioned increase the taste: Pediatrician Dr. Vivek Sharma told that the compound diethylene glycol and ethylene glycol mentioned in the WHO report is a carbon compound. It has neither fragrance nor color. It is sweet. It is added to children's syrups only so that they can drink easily.
Deadly in case of overdose: This compound can be mixed in medicines up to a maximum of 0.14 mg per kg. Mixing more than 1 gram per kg can cause death. WHO or these companies did not disclose the amount of these compounds in the drugs that caused death.
The effect of these compounds on humans occurs in 3 phases.
First phase: Vomiting, diarrhea, and abdominal pain in the first two days. The mind starts going numb. It is also called a minor coma.
Second phase: Kidney failure occurs on the third-fourth day. Unable to pass urine. Blood pressure increases. The heart rate also becomes irregular.
Third phase: Paralysis can occur from the fifth to the tenth day. The person can go into a deep coma. There can be deadly too. If once the patient becomes serious due to these compounds, even if he is saved, then there is a problem with the kidney. He may also need dialysis.
The compound of cough syrup that killed 66 children in the Gambia… the same took 33 lives in India too.
Drug use of diethylene glycol and ethylene glycol compounds is banned in the US, Australia, and Europe. But in India too, there has been a tragedy due to these chemical compounds twice.
1986: 21 patients died in Mumbai
In 1986, glycerin was given to many patients in a hospital in Mumbai during treatment. After this, 21 patients died due to kidney failure. The investigation found that the glycerin given to them contained diethylene glycol.
2020: 12 children died of cough syrup in Jammu and Kashmir
In 2020, the doctors of Chandigarh PGI complained to the Central Drug Authority CDSCO about a cough syrup COLDEST. Twelve children of Udhamnagar in Jammu and Kashmir died due to the use of this cough syrup. Diethylene glycol was also mixed in this cough syrup.
Then why no ban in India?
Diethylene glycol is a solvent used in medicines, especially syrups. But its quantity cannot exceed 0.14 mg per one kg.
Propylene glycol is mainly used as a solvent in children's syrups. But in comparison, diethylene glycol is cheaper. That's why pharma companies use it.
What are the other uses of diethylene glycol?
This chemical compound is used in the automotive industry, agrochemicals, and paints. It is also used as a flavor enhancer in many foods and beverages.
There is no FIR even on the company that caused the death of children in Jammu and Kashmir.
To date, no FIR has been lodged against the company that made the cough syrup COLDBEST due to which 12 children died in Jammu and Kashmir.
This company Digital Vision manufactures medicines in Kala Amb, Himachal. The Drug Authority of Himachal imposed a ban on the sale of drugs by the company in February 2020.
The Himachal High Court has set aside the order of the Drug Authority, holding that nothing wrong has been proved other than the batch of cough syrup in which diethylene glycol was found.
The Himachal Drug Authority had not lodged an FIR against the company till April 2022 as the post-mortem of the children who died had not been done. Because of this, his death cannot be directly linked to diethylene glycol.
1. Contents of Syrup Toxic to Humans
The WHO said that in September 2022, four cough syrups were being used in The Gambia. They were not meeting the standards. Upon examination in the lab, it was found that all the syrups contained such amounts of diethylene glycol and ethylene glycol, which could not be accepted. This was unnecessary. Both these ingredients are toxic to humans and can prove fatal.
2. Content can cause death
The ingredients included in these syrups have a toxic effect on the human body. These include abdominal pain, vomiting, diarrhea, inability to urinate, headache, unstable mental state, and kidney injury that can lead to death.
3. Instructed, children are most at risk
All batches of these products should be considered unsafe until tested by a national monitoring body. These can be especially dangerous for children. This can even lead to his death. These products should be immediately stopped from spreading to more places. These should be identified immediately so that they do not harm more patients.
4. Name the syrup manufacturer Haryana company, and name all the four syrups
WHO said that all four syrups are being made by Maiden Pharmaceutical Company of Haryana. The names of the four cough syrups in question are Promethazine Oral Solution, Cofaxmalin Baby Cough-Syrup, Macoff Baby Cough-Syrup, and Magrip N Cold Syrup. The pharmaceutical company has not yet given a safety and quality guarantee for these syrups to the WHO.
5. These syrups are sent through unofficial channels
The WHO has written in its report that the countries to which these products have been supplied and how they have been supplied should be immediately identified. Such unauthorized and illegal markets should also be identified. All medical products must be approved and sold by official and licensed suppliers. The genuineness and genuine condition of the product must be scrutinized very closely. If in doubt, consult a medical expert.
6. WARNING D. If you see any side effects, inform them immediately.
WHO said that do not use such substandard products at all. If you or someone else is using such a product and any serious side effect is observed, then immediately consult a medical expert. Apart from this, inform the institutions of your country.
Second question: What action was taken after the WHO report?
The Indian government has started its investigation after the deaths in The Gambia. This has been confirmed by the Ministry of Health. The WHO informed the Drug Controller General of India about these deaths last month. Since then DCGI has started its investigation. State government officials are also involved in this. WHO has asked health and medical institutions of other countries to report immediately if such products are identified there as well.
Question 3: Are syrups shipped only to the Gambia and sold in India?
It is clear from the WHO report that these products are not limited to the Gambia only. In The Gambia, they were identified after the deaths of children and it was found that their contents were lethal. WHO has expressed apprehension that these syrups may have been sent to other countries through illegal and unofficial means.
The Indian website of the company was not opening initially. Later it opened. The All India Organization of Chemists and Druggists said that the products of Maiden Pharmaceuticals Company are so far only shipped abroad. If the drug controller has issued any guideline then it will be followed.
Fourth question: Which is the company of Haryana?
Medan Pharmaceutical Limited of Haryana is named in the WHO report. The company was registered on 22 November 1990. The company with four directors had a general meeting in November last year. The company is active on paper but has not filled its balance sheet this year.
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