Haryana State Drugs Controller and Licensing Authority has issued show cause notice to Maiden Pharma after carrying out inspection at its manufacturing plant in Sonepat after the World Health Organization (WHO) linked the firm’s cough syrups to deaths of over 60 children in Gambia.
Department of Food & Drugs Administration, Haryana, issued the notice under the rule 85(2) of Drugs and Cosmetics Act, 1940 and Rules, 1945 to Maiden Pharma headquartered in New Delhi asking as to why the firm’s manufacturing license should not be suspended/cancelled since many contraventions were found during inspection. Business Today has reviewed the notice.
The WHO had linked four cough syrups - Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and MaGrip N Cold Syrup - manufactured by Maiden Pharma with deaths in Gambia.
“Complete plant is found under renovation. The firm failed to produce the log books of equipment's and instruments regarding manufacturing and testing for the drugs in question. Batch numbers of Propylene Glycol (P.G) IP and Sorbitol Solution and (70%) IP in the certificate of analysis respectively have not found mentioned, which was used in manufacturing of drug in question (sic),” the state FDA report dated 7 October reads.
“Batch number of Sodium Methyl Paraben IP in the certificate of analysis have not found mentioned, which was used in manufacturing of drug in question. Batch number of Sorbitol Solution (70%) IP have not found been mentioned, which was used in manufacturing of drug in question. The firm has not performed process validation and analytical method validation for the drug products in question (sic),” reads the FDA report.
The report found that the firm failed to produce the in-process testing report of the products in question. Batch number, manufacturer name, manufacturing date and expiry date were not found maintained on the purchase invoices of excipients including Propylene Glycol.
The firm has not performed the quality testing of Propylene Glycol for Diethylene Glycol and Ethylene Glycol, the report said. Propylene Glycol (batch number E1007/UP, E1105149) had failed as per certificate of analysis for the test in respect of water but was declared as of standard quality, said Manmohan Taneja, the State Drug Controller Cum Licensing Authority, FDA Haryana in the notice.
The state FDA further found that the Propylene Glycol (batch number E009844) having manufacturing date of September 2021 and expiry date of September 2023 was used in manufacturing of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, and MaGrip N Cold Syrup, having a product expiry of November 2024, demonstrating that the shelf-life of the product was more than that of raw material.
The state FDA that has submitted its report to the Union Health Ministry’s Central Drugs Standard Control Organisation (CDSCO) has asked Maiden Pharma to reply the show cause notice within 7 days of the receipt.
The WHO on September 29 informed the DCGI, the national drug regulator of India, that it is currently providing technical assistance and advice to Gambia, where the significant contributing factor leading to the death of children was suspected to be the use of medicines which may have been contaminated with diethylene glycol or ethylene glycol. Last week, the global health body said that the deaths in Gambia could be linked to contaminated cough and cold syrups which were manufactured by Maiden.
The WHO in a medical product alert had said, "The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup. 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."
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