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Toxic solvent, dodgy tests, gaps in data: Behind Maiden Pharma ban

Issuing the showcause notice on October 7, the state drug control department had given Maiden Pharmaceuticals a week's time to respond.

The Sonepat factory of Maiden Pharmaceuticals. (Express photo by Manoj Dhaka)

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

Issuing the showcause notice on October 7, the state drug control department had given Maiden Pharmaceuticals a week’s time to respond. On Wednesday, citing public interest, it ordered a “complete stop” on manufacturing activity at the company’s factory in Sonepat, Haryana.

The company exported a total of 50,000 bottles for fever, cough and cold to Gambia — it had received permission for 5 lakh bottles.

The showcause notice is based on inspections by a joint team of state and central drug regulators, on October 1, 3, 6 and 11.

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According to the showcause notice:

* The company manufactured a batch of syrups with November 2024 as the expiry date, for which it used a batch of propylene glycol as solvent that had an expiry date of September 2023. The company did not test for diethylene glycol and ethylene glycol in the solvent during quality control.

Sonepat: Maiden Pharmaceuticals Limited factory in Sonepat district, Thursday. (PTI Photo)

These were the two contaminants found in samples of the four syrups, according to the World Health Organisation (WHO). They can cause acute kidney injury and death in children. The children who died in Gambia had complained of vomiting, diarrhoea and inability to pass urine.

* All the four cough syrups stated their manufacturing dates as December 2021, although manufacturing only began in 2022, with two of the products receiving government permission only on February 2022.

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* The batch numbers of raw materials used in the syrups, including of propylene glycol which is suspected to have the contaminants, weren’t mentioned in several key Certificate of Analysis reports.

* In some Certificate of Analysis reports for propylene glycol, the manufacturing and expiry dates weren’t mentioned. And a couple of batches of propylene glycol failed one of the tests, but were still declared of standard quality in the Certificate of Analysis report.

* Although the company had submitted its six-month real-time and accelerated stability data, none of the four products were found in the 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.

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* The company failed to produce logbooks for equipment used for manufacturing the four syrups, did not perform the necessary validations for the products, and did not provide in-process test reports.

India has asked WHO to send the Certificate of Analysis reports for the 23 samples that were tested to confirm the presence of higher than permitted quantities of diethylene glycol and ethylene glycol in the four syrups.

Meanwhile, control samples – samples from the batches that were exported, stored by the company as part of quality control process – have been sent for testing at the regional drug testing laboratory in Chandigarh. Officials said the company will face further action depending on these reports.

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

First published on: 14-10-2022 at 04:10 IST
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