Maiden Pharmaceutical Limited, which is beneath the scanner for its 4 substandard pediatric cough syrups and probably linked to the loss of life of kids in The Gambia by the World Health Organization (WHO), didn’t carry out high quality testing of propylene glycol which was used within the 4 cough syrups.

As per the uncooked materials requisition slip, propylene glycol (batch quantity E1105149) used within the manufacturing of MaGrip n Cold Syrup was issued to the corporate on February 24, 2022, however the manufacturing date of the MaGrip n Cold Syrup (batch quantity ML 21) -198) was December 2021.

As per the October 7 show-cause discover issued by the Haryana drug authorities to Maiden after a joint inspection with Central Drugs Standard Control Organization (CDSCO) officers, “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,” stated an professional. The WHO had stated that laboratory evaluation of samples of every of the 4 merchandise confirmed that they contained unacceptable quantities of diethylene glycol and ethylene glycol as contaminants.

“Secondly, the propylene glycol batch was received and analyzed in March 2022 but the manufacturing date of MaGrip n Cold Syrup batch is December 2021 which means that it was not analyzed before the manufacturing of the cough syrup,” an professional stated.

“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 discover stated.

Listing out a collection of contraventions in the course of the inspection of Maiden’s manufacturing facility in Kundli, Sonepat, the state drug controller stated that batch variety of propylene glycol, sorbitol resolution and sodium methylparaben used within the manufacturing of drug in query haven’t been talked about within the certificates of study 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 stated within the show-cause discover.

The inspecting authorities additionally discovered that manufacturing and expiry dates have been lacking on the certificates of study of sure batches of propylene glycol.

Propylene glycol (batch quantity E1007/UP, E1105149) had failed as per the certificates of study for the take a look at in respect of water however was declared as customary high quality, the discover stated.

Also, batch numbers, producer title, manufacturing and expiry dates weren’t discovered maintained on the acquisition invoices of excipients, together with propylene glycol.

The show-cause discover was issued to the pharmaceutical firm beneath Section 85 (2) of the Drugs and Cosmetics Rules which allowed to the cancellation and suspension of the licence. Section 85 (2) empowers the licensing authority, which is the state drug controller, to cancel or droop manufacturing and export licenses of medicines if the licensee has didn’t adjust to any of the circumstances of the license or any provisions of the Drugs and Cosmetics Act or Rules. The motion is taken after issuing a show-cause discover to the errant firm to supply it with a possibility to clarify its facet of the story. The licenses, as per Section 85(2) will be canceled or suspended fully or in respect of a number of the substances it pertains to. The state drug controller can even direct the licensee to cease the manufacture, sale or distribution of the stated medicine and in addition order the destruction of medicine and the inventory if the licensee has didn’t adjust to license circumstances, provisions of the Act or Rules.