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Cough Syrups Controversy: Haryana Drug Regulator Asks Maiden Pharmaceuticals To Explain 'Contraventions'

As per media reports, the Haryana government has stopped their production after significant discrepancies were identified in manufacturing at the facilities of Maiden Pharmaceuticals. 

The four contaminated cough syrups manufactured by Maiden Pharmaceuticals
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The Haryana drug regulator.on Wednesday asked Maiden Pharmaceuticals, the manufacturer of 4 contaminated cough syrups, flagged by WHO, to explain the "contraventions".

As per media reports, the Haryana government has stopped their production after significant discrepancies were identified in manufacturing at the facilities of Maiden Pharmaceuticals. 

"Samples of 3 drugs mentioned by WHO of Sonipat's pharmaceuticals company were sent to Central Drug Lab in Kolkata. The reports are not in yet, action will be taken after that," Haryana Health Minister Anil Vij told, as per media reports.

He also added that around 12 flaws in manifacturing.were identified by a joint inspection by the Central and Haryana state drug departments found

"Keeping which in mind, it has been decided that the total production shall be stopped; notice given," Mr Vij added.

What were the irregularities?

According to the show cause notice issued to the company, the pharmaceutical firm could not produce a log book of equipment and instruments deployed to produce and test the drugs in question. 

The chemicals in question include Propylene Glycol, Sorbitol Solution, and Sodium Methyl Paraben. 

The company has also  failed to validate process and methods in the manufacture of the syrups in question.

A batch of propylene glycol, which was analysed by the company and declared of "Standard Quality" failed in certain respects.

In-process testing reports were not provided to investigators of the cough syrups in question. 

There are discrepancies in the date of manufacturing and product permission which was given.

The Haryana State Drugs Controller has given the manufacturer 7-days time to respond to its show cause notice, barring which the manufacturing licence may be suspended or cancelled.

The Indian government has started a probe into the manufacturing of cough syrup by a Haryana-based pharmaceutical firm after the World Health Organisation (WHO) warned that they could be linked to the deaths of 66 children in The Gambia, West Africa. 

The WHO on previously 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. 

The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.

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.

What has WHO said?

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. 

The WHO has warned that the syrups may have been distributed outside the West African country and global exposure is "possible".

The health regulatory body further said that the syrup has been "potentially linked" with acute kidney injuries and 66 deaths among children in The Gambia.

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