Maiden Pharma didn't test cough syrups for toxic contaminants: Report
Maiden Pharmaceuticals Limited, which is under the scanner for its “spurious” cough syrups which may have led to the deaths of 66 children in Gambia, did not perform quality testing of a raw material used in the manufacture of one of the medicines, a preliminary report prepared by India’s drug regulator in collaboration with Haryana drug authorities has said.
The report by the Central Drugs Standard Control Organisation (CDSCO), which was prepared following an official inspection, has been sent to the Union health ministry and the Prime Minister’s Office. A show cause notice on the same was also sent to Maiden Pharmaceuticals on October 7. The pharma company has been asked to reply by October 14, failing which necessary action will be taken against it.
The World Health Organisation (WHO) had said that propylene glycol, an ingredient used in the manufacture of cough syrups, which often has traces of two toxic contaminants –diethylene glycol and ethylene glycol –may have caused the death of the children.
Also read: Cough syrups made by Maiden Pharma sent to CDL Kolkata for examination
High traces of the two contaminants in medicines can lead to kidney failure and be fatal in many cases, especially in children with low body weight.
According to the drug regulator’s report, during inspection at the manufacturing plants of Maiden Pharmaceuticals in Haryana’s Kundli and Sonepat, it was found that the pharma company had skipped the quality testing of propylene glycol to check for the presence of the two contaminants.
Shoddy paperwork
The report said that details of propylene glycol that was received and analysed in March 2022 matched with that used in the manufacture of MaGrip n Cold Syrup in December 2021, indicating that no separate tests were conducted to test for the quality of the ingredient.
The report said in one case the shelf life of the drug superseded the expiry date of the raw material used in it.
“Propylene glycol (batch number E009844) having manufacturing date of Sept 2021 and expiry date of Sept 2023 was used in manufacturing of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, and MaGrip n Cold Syrup having a product expiry of November 2024,” it said.
Results from the samples sent to find any contamination of the suspected batches of cough syrups are still awaited.
Also read: ‘Killer cough syrups’ maker Maiden Pharma is a repeat offender in India
“There are evidences of shocking lapses in maintaining GMP (Good Manufacturing Practices) standards on the part of the manufacturer and necessary action would be initiated against once the lab test results are received,” a government sourced told Money Control.
Quoting an official of Haryana’s food and drug administration department, MC, said that the company during the inspection couldn’t provide log books of equipment and instruments used in the manufacture and testing of drugs that were sent to Gambia.
The drug regulator’s report also mentioned about discrepancies in the batch numbers of propylene glycol and other solvents used in concocting the cough syrups in comparison with the certificate analysis – prepared for each batch – report of the cough syrup.
Also read: Indian cough syrups smuggled to Bangladesh for tipplers: BSF report
Earlier this week, the WHO had red flagged four cough syrups manufactured by the company – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – after they were linked with the deaths of 66 children in the west African nation.
