Union Health Ministry’s Central Drugs Standard Control Organisation (CDSCO) said, on Wednesday, that it will examine the response of Haryana-based Maiden Pharmaceuticals Limited to allegations of serious violations of norms set for the production of drugs by the Haryana State Drugs Controller.
Haryana Health Minister Anil Vij told ANI that authorities inspected a Maiden factory in the town of Sonepat in the State and found 12 violations of good practices. Production was ordered stopped, Mr. Vij said.
The State Drugs Controller-Cum-Licensing Authority, 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 asking as to why the firm’s manufacturing license should not be suspended/cancelled since many contraventions were found during inspection.
The company response is expected by the end of the week.
The World Health Organisation on September 29 informed the Union Health Ministry about four cough syrups – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — manufactured by the company allegedly being a contributing factor leading to the death of children in Gambia. The WHO issued an alert stating that the medicines may have been contaminated with diethylene glycol or ethylene glycol.
The Haryana State Drug Controller in its seven-page show-cause notice said that there have been serious violations of norms set for the production of drugs and has raised red flag over multiple discrepancies detected after inspecting the Maiden Pharmaceutical’s manufacturing facility in Sonepat.
In its communication dated October 7 addressed to the company and issued by Manmohan Taneja, the State Drug Controller Cum Licensing Authority, FDA Haryana said: "Your reply to this show-cause notice must reach this office within 7 days of the receipt of this notice, failing which ex-parte action shall be liable to be taken against you as per the Drugs and Cosmetics Act, 1940 & Rules, 1945."
It has further said that the "Firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question and that it did not perform process validation and analytical method validation for the drug products in question." Also batch numbers of Propylene Glycol (P.G) IP and Sorbitol Solution and (70%) IP in the certificate of analysis respectively have not been mentioned, which was used in manufacturing of drugs in question.
It further noted that the firm failed to produce the in-process testing report of the products in question. "Dates were not found maintained on the purchase invoices of excipients including Propylene Glycol also the firm has not performed the quality testing of Propylene Glycol for Diethylene Glycol and Ethylene Glycol," it said.
The notice added that the firm has submitted the six-month real time and accelerated stability data of drugs in question however at the time of investigation none of the above said product was found charged in the stability chamber.