Haryana has halted production at Maiden Pharmaceuticals’ Sonipat plant after the World Health Organization (WHO) last week said cough syrups produced made by the company could be linked to the deaths of 66 children in Gambia.
News agency ANI quoted health minister Anil Vij as saying that while laboratory reports of the samples collected from the company are awaited, the state had decided to halt total production at the plant. A joint inspection by the state Food and Drugs Administration and Central Drugs Standard Control Organisation (CDSCO) found 12 violations of good manufacturing practices in the Sonipat facility, he said.
A team comprising Rakesh Dahiya, senior drugs control officer, Sonipat, Sandeep Kumar, and Devender Pratap Singh, drug inspectors from CDSCO zonal office in Ghaziabad, inspected the facilities of Maiden Pharma on October 1 and 3.
A show-cause notice was issued on October 7 under Rule 85 (2) of Drug Rules, 1945 by the State Drugs Controller-cum-Licensing Authority in Panchkula asking the firm why its manufacturing license may not be suspended/cancelled. The company has to respond to the notice within seven days, failing which action will be initiated. There are two more days to go before the state licensing authority may decide to cancel or suspend their manufacturing license altogether.
During inspection the authorities found that batch numbers, expiry and manufacturing dates, name of manufacturer were missing from the invoices of propylene glycol, an ingredient used in cough syrups. Drug authorities noted Maiden Pharma has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol. The firm failed to produce the log books of equipment and instruments regarding manufacturing and testing for the drugs in question.
The firm had not performed process validation and analytical method validation for the drug products of these four cough syrups, the state regulator has said. Issues with stability study of the four cough syrups have been detected. The Inspection team did not find the cough syrups charged/monitored in stability chambers. However, the firm had submitted accelerated stability study data when seeking marketing authorization, an indication of data being fudged.