Days after the Haryana government directed Maiden Pharma to stop the production of cough syrup at its Sonipat Plant, several other states have taken a stricter stance for cough syrup production this week.
While Maharashtra has ordered the recall of all cough syrups produced by Maiden Pharma and directed the state’s food and drug administration to check all units of liquid syrup production, Karnataka has asked the drugmakers to submit the analysis of glycerine and propylene glycol in the next seven days.
Meanwhile, Kerala has also halted the production of cough syrups by Maiden Pharma in the state.
On October 6, the World Health Organisation issued a global alert against the cough syrups produced by Maiden Pharma, after 66 children died in The Gambia following the consumption of cough syrups. The WHO sent 23 cough syrup samples for testing, of which the laboratory analysis of the samples of each of the four products confirmed they contain "unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.”
Both diethylene glycol and ethylene glycol, when consumed, are proven to be fatal to human beings. The WHO also said that the four products have only been identified in the Gambia but have been distributed to other African nations. However, the Indian government has said that the export of these products was only limited to the Gambia.
“The stated manufacturer of these products is Maiden Pharmaceuticals Limited (Haryana, India). To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products," WHO said.
The WHO has also issued an alert that medicines such as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup contain "unacceptable” amounts of diethylene glycol and ethylene glycol.
Following this, last week, Central Drugs Standard Control Organisation (CDSCO), the country’s drug regulator initiated a probe against Maiden Pharma.
Maiden Pharma’s murky history
However, this is not the first time that maiden Pharma has been embroiled in the controversy. The records shared by Dinesh Thakur, a public health activist showed that the cough syrups sold by Maiden Pharma are blacklisted in Vietnam in 2014. In 2017, the company was prosecuted by the Haryana government for quality violations under the Drugs and Cosmetics Act. The same year, Maiden Pharma was fined by the Kerala government over quality issues. In 2011, Maiden Pharma was amongst the two pharmaceutical firms that were blacklisted for supplying sub-standard syrups and tablets. The other company was Man Pharma.