Cough Syrup Deaths: Haryana Govt Stops Production; Maiden Pharma 'Missed Key Test of Propylene Glycol'

Maiden Pharmaceuticals Limited, the company under investigation for four “substandard” and “contaminated” cough syrups potentially linked to the deaths of 66 children in Gambia, did not perform quality testing of a raw material used in the manufacture of one of the medicines, according to a report. The Haryana government has also stopped the production of the said cough syrups.

“After the Central and Haryana State drug departments conducted a joint inspection, around 12 flaws were found, keeping which in mind, it’s been decided that the total production shall be stopped; notice given,” Haryana Home and Health Minister Anil Vij was quoted as saying by ANI.

The Hindustan Times reported that Haryana drug authorities issued a show-cause notice to Maiden Pharmaceuticals on October 7 following a joint inspection with the Central Drugs Standard Control Organisation (CDSCO), stating that “the firm has not performed the quality testing of propylene glycol for diethylene glycol and ethylene glycol.” The pharma company must respond to the notice by October 14, or else action will be taken against it, the report said.

Gambia’s Health Minister Ahmadou Lamin Samateh had earlier announced that 69 children died as a result of kidney damage caused by contaminated cough syrup made in India.

Experts have said that propylene glycol, which is used to make drugs, can contain contaminants such as diethylene glycol and ethylene glycol. The World Health Organization (WHO) has identified these two chemicals as potential causes of child deaths in Gambia.

According to the notice, a batch of propylene glycol received and analysed in March 2022 was found to be the same one used to manufacture a batch of MaGrip n Cold Syrup in December 2021, indicating that it was not likely tested for quality and that the paperwork was not in order.

“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 notice stated, indicating that the drugs’ shelf life was set to be longer than the raw material’s expiry date.

The Haryana drug controller stated that the batch number of propylene glycol, sorbitol solution, and sodium methyl paraben used in the manufacturing of the drugs in question was not mentioned in the certificate of analysis report, among other violations discovered during an inspection of Maiden Pharmaceutical’s manufacturing facility in Kundli, Sonepat.

“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 drugs in question. However, at the time of investigation none of above said products were found to be (monitored) in stability chamber,” the report quoted the state drug controller as saying in the notice.

The inspecting authorities also discovered that the manufacturing and expiry dates on the certificates of analysis for certain batches of propylene glycol were missing. On purchase invoices for items used, including propylene glycol, batch numbers, manufacturer names, and manufacturing and expiry dates were not found, the report said.

The show-cause notice was served on the pharmaceutical company in accordance with Section 85 (2) of the Drugs and Cosmetics Rules, which governs the cancellation and suspension of firm licences. Section 85 (2) authorises the licencing authority to cancel or suspend a licensee’s manufacturing and export licence for failing to comply with any of the provisions of the Drugs and Cosmetics Act or Rules.

Read all the Latest News India and Breaking News here