E-Paper
Gambia cough syrup deaths: Maiden pharma did not perform quality test of propylene glycol, says notice
As per October 7 notice issued by Haryana drug authorities to Maiden pharma after a joint inspection with CDSCO officials, “the firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol.”
Maiden Pharmaceutical Limited, which is under the scanner for its four substandard paediatric cough syrups and potentially linked to the death of children in The Gambia by the World Health Organization (WHO), did not perform quality testing of propylene glycol which was used in the four cough syrups.
As per the raw material requisition slip, propylene glycol (batch number E1105149) used in the manufacturing of MaGrip n Cold Syrup was issued to the company on February 24, 2022, but the manufacturing date of the MaGrip n Cold Syrup (batch number ML 21-198) was December 2021.
As per the October 7 show-cause notice issued by the Haryana drug authorities to Maiden after a joint inspection with Central Drugs Standard Control Organisation (CDSCO) officials, “the firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol.” The pharma company has to reply to the show-cause notice by October 14, failing which ex-parte action can be taken against them.
Pharmaceutical experts said this meant that tests should have been performed on the propylene glycol stocks to check the contamination of diethylene glycol and ethylene glycol but were not done. “Propylene glycol is expensive and many times defaulting pharmaceutical companies mix it with diethylene glycol and ethylene glycol,” said an expert. The WHO had said that laboratory analysis of samples of each of the four products confirmed that they contained unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.
“Secondly, the propylene glycol batch was received and analysed in March 2022 but the manufacturing date of MaGrip n Cold Syrup batch is December 2021 which means that it was not analysed before the manufacturing of the cough syrup,” an expert said.
“Propylene glycol (batch number E009844) having a manufacturing date of September 2021 and expiry date of September 2023 was used in the manufacturing of Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, and MaGrip n Cold Syrup having a product expiry of November 2024,” the notice said.
Listing out a series of contraventions during the inspection of Maiden’s manufacturing facility in Kundli, Sonepat, the state drug controller said that batch number of propylene glycol, sorbitol solution and sodium methylparaben used in the manufacturing of drug in question have not been mentioned in the certificate of analysis report.
“The firm has not performed process validation and analytical method validation for the drug products in question. The firm has submitted six-month real-time and accelerated stability data of the drugs in question. However, at the time of the investigation, none of the above said products were found charged in the stability chamber,” the state drug controller said in the show-cause notice.
The inspecting authorities also found that manufacturing and expiry dates were missing on the certificate of analysis of certain batches of propylene glycol.
Propylene glycol (batch number E1007/UP, E1105149) had failed as per the certificate of analysis for the test in respect of water but was declared as standard quality, the notice said.
Also, batch numbers, manufacturer name, manufacturing and expiry dates were not found maintained on the purchase invoices of excipients, including propylene glycol.
The show-cause notice was issued to the pharmaceutical company under Section 85 (2) of the Drugs and Cosmetics Rules which pertained to the cancellation and suspension of the licence. Section 85 (2) empowers the licencing authority, which is the state drug controller, to cancel or suspend manufacturing and export licences of medicines if the licensee has failed to comply with any of the conditions of the licence or any provisions of the Drugs and Cosmetics Act or Rules. The action is taken after issuing a show-cause notice to the errant company to provide it with an opportunity to explain its side of the story. The licences, as per Section 85(2) can be cancelled or suspended completely or in respect of some of the substances it relates to. The state drug controller can also direct the licensee to stop the manufacture, sale or distribution of the said drugs and also order the destruction of drugs and the stock if the licensee has failed to comply with licence conditions, provisions of the Act or Rules.
