The Centre on Wednesday, 12 October, formed a four-member expert committee to investigate the deaths of 66 children in the Gambia, which were linked to Haryana-based Maiden Pharmaceuticals Limited.
The committee will comprise the Vice Chairperson of the Standing National Committee on Medicines Dr YK Gupta, ICMR-NIV’s Dr Pragya Yadav, NCDC Division of Epidemiology’s Dr Arti Bahl, and Central Drugs Standard Control Organisation's AK Pradhan.
The update comes even as the Haryana-based company has been forced to stop all production, after the Central Drugs Standard Control Organisation and the state health authorities found “12 flaws during inspection,” Haryana’s Health Minister Anil Vij told Economic Times.
What Are the Flaws?
According to the notice, to which Maiden Pharmaceuticals has to respond by 14 October, the company did not perform “the quality testing of propylene glycol for diethylene glycol and ethylene glycol.” The World Health Organization (WHO) had earlier pointed out that diethylene glycol and ethylene glycol could be responsible for the deaths.
Maiden Pharmaceuticals used the same batch of propylene glycol to manufacture the cough syrups in March 2022 that it had used in December 2021 to manufacture MaGrip n Cold Syrup, “which indicates that it was not likely tested for quality and the paperwork was not in order."
The show cause notice was issued under the Drugs and Cosmetics Rules (1945) Section 85 (2). According to the Economic Times, the investigation report was shared with the Union health minister on Tuesday, 11 October, while the test reports from Kolkata are still awaited.
Did Maiden Pharma Tamper Expiry Dates?
Not just this, questions are also being raised over whether the company also tampered with the expiry date of the cough syrups. The notice stated:
“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.”
The Haryana drugs authority also pulled up the company for not mentioning in the analysis report which batch numbers of propylene glycol, sorbitol solution, and sodium methyl paraben were used to manufacture the four cough syrups that have been now banned in the Gambia.
The notice said, “At the time of investigation, none of above said products were found to be (monitored) in stability chamber.” It added, “Propylene glycol (batch number E1007/UP, E1105149) had failed as per certificate of analysis for the test in respect of water but was declared as of standard quality.”
The manufacturing and expiry dates of propylene glycol batches were not mentioned on the analysis certificates, the notice pointed. For certain other items, the batch number, the manufacturer’s name, the manufacturing dates, and the expiry dates were missing from the purchase invoice, it added.
According to the notice, while two of the cough syrups received government permission in February 2022, all four of them had December 2021 mentioned as their manufacturing date.