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The issue of the cough syrup made by India’s Maiden Pharmaceuticals has taken a new turn, with Gambia saying it has not yet confirmed that the cough syrup caused the death of 70 children from acute kidney injury.
Health ministry sources indicated that India is currently investigating the Haryana-based drug maker for lapses in good manufacturing practices. The regulator here also stopped production at its Sonipat site last month. “We have nothing to update as of now, the investigation is ongoing,” the official said.
According to a Reuters report from Gambia, a representative of the country’s Medicines Control Agency said they have not yet confirmed that the cough syrup caused the deaths of 70 children. The report claimed Gambia has been investigating the deaths of children in recent months, and that a preliminary probe linked four cough syrups made by India’s Maiden Pharma to the deaths.
The agency further reported that Gambia’s Medicine Control Agency has not yet pin-pointed the exact cause of death – a good number of children have died without taking any medication. Samples of the medication taken by some of the kids who died were found to be of good quality when tested.
The spike in the number of cases of acute kidney injury among children below five years was detected in July.
On September 29, the World Health Organization (WHO) informed the Indian drug controller about the Gambia deaths and suspected linkage with Maiden Pharma.
The Central Drugs Standard Control Organisation (CDSCO) took up the matter immediately with Haryana’s regulatory authority. Preliminary enquiry by CDSCO showed that Maiden Pharma is a manufacturer licensed by the state drug controller for Promethazine Oral Solution BP, Kofexnalin Baby Cough Syrup, MaKoff Baby Cough Syrup and MaGrip n Cold Syrup. It holds permission to manufacture these products for export only, the Union government said. “The company has manufactured and exported these products only to Gambia,” it had added. The products aren’t sold in India.
Haryana FDA halted production at Maiden Pharma’s site on October 12. A joint inspection by the state FDA and CDSCO found 12 violations of good manufacturing practices in the Sonipat facility.
A team consisting of Rakesh Dahiya, senior drug control officer, Sonipat, and Sandeep Kumar and Devender Pratap Singh, drug inspectors from CDSCO zonal office, Ghaziabad, inspected Maiden Pharma’s units on October 1 and 3.
During the inspection the authorities found that batch numbers, expiry and manufacturing dates, and the 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.
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