In an exclusive interview with ANI, State Health Minister Anil Vij said, "The samples of three drugs of the Sonipat-based pharmaceutical company which were mentioned by WHO, have been sent to Central Drug Laboratory in Kolkata. The report is yet to come."
"We will take action only after the report comes. After a joint inspection by Central and State officials, 12 violations were found in the manufacturing facility. It has been decided to shut total production. We have sent a notice in this regard," Vij further said.
The pharma company that is under the scrutiny for four 'substandard' and 'contaminated' cough syrups potentially linked to the deaths, did not perform the quality test of raw material used in the manufacturing process of one of the medicines, according to a notice sent after an official inspection in the case.
The four cough syrups linked to the deaths in the West African nation are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
The show-cause notice was issued by the Haryana drug authorities to Maiden Pharma after a joint inspection with the Central Drugs Standard Control Organisation (CDSCO) on October 7.
Experts had said that Propylene glycol, which is used to manufacture drugs, can contain contaminants like diethylene glycol and ethylene glycol. These two chemicals have been named by the World Health Organization (WHO) as possible causes of the deaths of children in The Gambia.
According to the notice, Propylene glycol (batch number E009844) having a manufacturing date of September 2021 and expiry date of September 2023 was used in the manufacturing of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, and MaGrip n cold syrup having a product expiry of November 2024, which indicates that the shelf life of the drugs was fixed to be longer than the expiry period of the raw material.
The WHO also issued an alert stating that laboratory analysis of samples of each of the four products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol.
During the inspection, the Haryana drug controller also said that the batch of chemicals in question was not mentioned in the certificate of the analysis report.
(With ANI inputs)
