CHANDIGARH/NEW DELHI, Oct 12: The Haryana Government has halted all drug production at the Sonipat factory of Maiden Pharmaceuticals, a week after the World Health Organization (WHO) potentially linked four cough syrups manufactured at the facility to the deaths of 66 children in Gambia.
The State authorities also issued a show-cause notice to the pharma company to explain within a week “many contraventions” found during a recent inspection, or face suspension or cancellation of license even as the Centre today formed a four-member panel of experts to examine the details and adverse event reports received from the WHO on the deaths of the children in the West African nation.
Haryana Health Minister Anil Vij said a joint team of the state and the Centre inspected the Sonipat unit during which it found 12 violations or deficiencies.
“Taking cognisance of this, the State Government has ordered that all drug production at this unit be stopped with immediate effect,” Vij told reporters.
Among the 12 “violations” highlighted by the state drugs regulator was that the batch number of propylene glycol, sorbitol solution and sodium methyl paraben used in the making of the drugs in question was not mentioned in the certificate of analysis report.
According to the show-cause notice issued by the Haryana Drugs Controller following the inspection of the firm’s plant, Maiden Pharmaceuticals Limited did not perform quality testing of propylene glycol, the raw material used for making one of the formulations.
“The firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol,” the notice issued on October 7 said.
The inspection of the firm was conducted by a team comprising senior officials from the Central Drugs Standard Control Organisation (CDSCO) and the Haryana Drugs Controller Authority.
“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,” the notice said.(PTI)
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