Thursday, Oct 05, 2023

Maiden Pharma Under WHO Scanner Over Cough Syrup Is A Repeat Offender: 10 Points

Maiden Pharma Under WHO Scanner Over Cough Syrup Is A Repeat Offender: 10 Points

Four cough syrups manufactured by the said pharma has allegedly led to death of 66 children in the Gambia, following which the World Health Organisation (WHO) has issued an alert.

The Haryana-based pharmaceutical manufacturing the cough syrup.
The Haryana-based pharmaceutical manufacturing the cough syrup. Reuters/Twitter

Haryana-based Maiden Pharmaceuticals, which has cine under the radar for exporting faulty medicine, has been a repeated offender, according to media reports. Several drugs by the pharma company were not found to be up to quality standards by four states of the country. 

Four cough syrup manufactured by the said pharma has led to the death of 66 children in the Gambia, following which the World Health Organisation (WHO) has issued an alert. 

The cough syrup row in India has raised eyebrows after fatal elements like contained diethylene glycol and ethylene glycol, were found in its content. These chemicals can lead to severe liver and kidney damage.  

Here's what has happened so far:

  1. On Thursday, the government started a probe into the manufacturing of cough syrup by Maiden Pharmaceuticals after the (WHO) that they could be linked to the deaths of 66 children in The Gambia, West Africa. The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
  2. The WHO warned that four "contaminated" and "substandard" cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana's Sonepat could be the reason for the deaths in the West African nation. 
  3. According to reports, WHO had alerted the Drugs Controller General of India (DCGI) on September 29 about the potentially harmful effects of the medicine, following which DCGI took up the matter with the Haryana regulatory authority and launched a detailed investigation, the health ministry said. 
  4. WHO Director-General Tedros Adhanom Ghebreyesus said, "The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited in India. WHO is conducting further investigation with the company and regulatory authorities in India." Further, he added that the loss of young lives due to the products is "beyond heart-breaking for their families". The manufacturer of these products “to date, has not provided guarantees to WHO on the safety and quality of these products”, it added. 
  5. The four cough syrups were found to have unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. WHO said that Diethylene Glycol (DEG) or ethylene glycol is toxic to humans when consumed and can prove fatal. The contents are known to cause kidney and neurological toxicity and have been associated with several cases of mass poisoning when consumed via drugs.
  6. The WHO has not yet provided details on when these deaths took place. The sources from the government said the exact "one-to-one causal relation of death" has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the Central Drugs Standard Control Organisation (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products.
  7. The Centre said none of the four is sold in India. In a press release, the Union Health Ministry said, "The State Drug Controller had given licenses to the said Company only for export of these four drugs namely Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. Further all these 04 drugs manufactured only for exports by M/s. Maiden Pharmaceuticals Limited are not licensed for manufacture and sale in India. In effect, none of these four drugs of M/s. Maiden Pharmaceuticals is sold domestically in India."
  8. According to a report by NDTV, in 2011 Vietnam had banned medicines manufactured by the Haryana-based firm. The company's medicines have been flagged for quality issues in India as well, the report states. Speaking to the news media, a public health expert said that during research, regulators in Kerala and Gujarat had said that Maiden Phrama's medicines were of poor quality. The public procurement agency of Bihar had also blacklisted a syrup.
  9. A Kerala drug inspector even filed a case in 2005, after which the company was fined in 2017. In another case, a central government drug inspector prosecuted the company in Sonipat for quality violations under the Drugs & Cosmetics Act. The company was charged for offences related to adulteration. 
  10. Haryana Health Minister Anil Vij said samples of four cough syrups manufactured by the firm have been sent to the Central Drugs Laboratory in Kolkata for examination.

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