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.