PremiumThe state authority has warned Maiden Pharmaceuticals to reply within seven days, failing which the officials will take ex-parte action against the firm as per the drugs act.
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New Delhi: The Haryana Drug Controller has issued a show cause notice to Maiden Pharmaceuticals after an inspection at the company's plant following the World Health Organization’s (WHO) claim that the cough syrups supplied by the drugmaker caused the death of 66 children in Gambia, Africa.
“The inspection of your firm was conducted by team comprising of the senior officials from CDSCO (Central Drugs Standard Control Organisation) and Haryana Drug Controller Authority to conduct the necessary investigation for following drugs manufactured by you. During inspection many contraventions were detected. You are hereby served with the show cause notice rule 85(2) of drug rules, 1945 as to why your manufacturing license may not be suspended or cancelled," stated a communication by Manmohan Taneja, Haryana Drug Controller in show cause notice issued to Maiden pharmaceuticals, reviewed by Mint.
According to initial results received by the WHO, out of the 23 samples tested, four were found to contain diethylene glycol or ethylene glycol.
The state authority has warned Maiden Pharmaceuticals to reply within seven days, failing which the officials will take ex-parte action against the firm as per the drugs act.
Stating the list of contraventions detected during investigations on 1 October and 3 October, Haryana Drug Controller said, “Complete plant is found under renovation. The firm failed to produce the log books of equipment and instruments regarding the manufacturing and testing of the drugs in question. Batch numbers of propylene Glycol and Sorbitol Solutions (70%) IP in the Certificates of Analysis (CoA) report number MPLR22031105 and MPLR22022301 respectively have not been found mentioned, which was used in manufacturing of drugs in question. Batch number of Sodium Methyl Paraben IP in the CoA report number MPLR22022301 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. The firm has submitted the 6-month real-time and accelerated stability data of drugs in question however at the time of investigation none of above-said products found charged in stability chamber, the notice said.
“On certificate of analysis of Propylene Glycol IP with batch number E02401-UP, EO09844, E10/UP and E1105194, manufacturing and expiry date have not found mentioned," it said.
“As per the raw material requestion slip the material was issued on 24.02.2022. Further propylene glycol IP batch number E1007/UP, E1105149 were failed as per CoA for the test in respect of water while declared as of Standard Quality. As per report no. MPLR22031105 batch number, manufacturing date and expiry date of propylene glycol were not found mentioned. The said batch is also failed in respect of water."
“The firm failed to produce the in-process testing report of the products in question. Batch number, manufacturer name, manufacturing date, expiry date was 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," read the showcase notice.