There are toxic solvents, dodgy tests, and gaps in data behind the ban of Maiden Pharma

The use of a solvent which was set to expire before the expiration date of the medicine; the solvent was not tested for contaminants; discrepancies in manufacturing dates; and batch numbers were not provided in key test reports. Four cough syrups manufactured by Maiden Pharmaceuticals have been linked to the deaths of at least 69 children in the Gambia, among the “12 faults” listed in the showcause notice issued to the company.

The state drug control department issued the showcause notice on October 7 and gave Maiden Pharmaceuticals a week to respond.

The company ordered a “complete halt” on manufacturing activity at its factory in Sonepat, Haryana, on Wednesday, citing public interest.

A total of 50,000 bottles of fever, cough, and cold medicines were exported to Gambia. The company had been granted permission to export 5 lakh bottles.

A joint team of state and federal drug regulators conducted inspections on October 1, 3, 6 and 11 that led to the show cause notice.

In accordance with the notice of show cause:

  • During the manufacture of a batch of syrups with an expiry date of November 2024, the company used propylene glycol as a solvent that expired in September 2023. As part of the quality control process, the company did not test the solvent for diethylene glycol and ethylene glycol.
The Sonepat factory of Maiden Pharmaceuticals.
    • The World Health Organization (WHO) found these two contaminants in samples of the four syrups. It is possible for them to cause acute kidney injury and death in children. Children who died in Gambia complained of vomiting, diarrhea, and incontinence.
  • Two of the cough syrups received government approval only in February 2022, despite the fact that all four cough syrups stated they were to be manufactured in December 2021.
  • There are several key Certificates of Analysis that do not include the batch numbers of raw materials used in the syrups, including propylene glycol, which is suspected to contain the contaminants. Two batches of propylene glycol failed one of the tests, but their Certificate of Analysis still declared them to be of standard quality.
  • However, none of the four products were found in stability chambers – rooms controlled for temperature, humidity and several other factors to study how long it takes for a medicine to degrade – at the time of inspections, despite the company having submitted its six-month real-time and accelerated stability data.
  • In addition, the company failed to provide logbooks for the equipment used to produce the four syrups, failed to perform the necessary validations for the products, and failed to provide in-process testing reports.
  • To confirm the presence of higher than permitted quantities of diethylene glycol and ethylene glycol in the four syrups, India has asked WHO to send the Certificate of Analysis reports for the 23 samples tested.

Meanwhile, control samples from the batches that were exported and stored by the company as part of their quality control process have been sent to the Chandigarh regional drug testing laboratory for analysis. Depending on the results of these reports, the company may face further action.

The Union health ministry set up a committee on Wednesday to examine and analyze the details of the reports, adverse events, and certificates of analysis received or to be received from WHO.  Y K Gupta, Vice-Chairperson of the Standing National Committee on Medicines. Pragya Yadav, Senior Scientist at the National Institute of Virology-Pune, Dr Arti Bahl, Additional Director and Head of Epidemiology at the National Centre for Disease Control, and A K Pradhan, officer at the Central Drugs Standards Control Organization, make up the committee.

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