Haryana to seek DCGI inspection of Sonepat-based Maiden Pharma's premises

Bhartesh Singh Thakur

Chandigarh, December 16

After laboratory tests of control samples failed to establish contamination of cough syrups manufactured by Sonepat-based Maiden Pharmaceuticals, the State Drug Controller, Haryana, will write to the Drug Controller General of India (DCGI) for a joint inspection of the firm’s premises.

Firm stopped production on Oct 11

For failure to comply with good manufacturing practices (GMP), we issued a show-cause notice to Maiden Pharmaceuticals on October 7 and directed the firm to stop production on October 11. — Manmohan Taneja, Haryana State Drug Controller

Health Minister Anil Vij, who holds the charge of the Food and Drugs Administration (FDA), held a meeting with State Drug Controller Manmohan Taneja in that regard. He went through the lab test report of the Central Drugs Standard Control Organisation (CDSCO) regarding syrups, exported by Maiden Pharmaceuticals to Gambia. He instructed Taneja to write to the DCGI for a joint inspection of the firm’s premises.

Gambia reported the death of 70 kids due to acute kidney injury (AKI). Its health ministry had cautioned parents and caregivers not to use syrups manufactured by Maiden Pharmaceuticals. The WHO issued an alert on syrups on October 5.

As no contamination has been found in the syrups by Chandigarh-based Regional Drug Testing Laboratory (RDTL), DCGI VG Somani wrote to the WHO on December 13 saying that diethylene glycol and ethylene glycol were not detected in the products and propylene glycol used in the syrups was sourced from Goyal Pharma Chem, Delhi, which imported it from a firm in South Korea.

Propylene glycol is used as a solvent in pharmaceutical drugs. If contaminated with diethylene glycol or ethylene glycol, it can cause death.

Talking to The Tribune, Haryana State Drug Controller Manmohan Taneja said, “For failure to comply with good manufacturing practices (GMP), we issued a show-cause notice to Maiden Pharmaceuticals on October 7 and directed the firm to stop production on October 11. Now, Health Minister Anil Vij has instructed me to write to the DCGI to constitute a joint inspection panel so that their reply can be scrutinised and the firm can be inspected vis-à-vis contraventions detected during earlier inspections.”

He said further action would be taken on the basis of the joint inspection committee’s report. As per the show-cause notice, Maiden Pharmaceuticals did not “perform quality testing of propylene glycol for diethylene glycol and ethylene glycol”. The batch no., manufacturer name, manufacturing date and expiry date were not mentioned on purchase invoices.

“The firm failed to produce the log books of equipment and instruments regarding manufacturing and testing of drugs in question,” said the notice. The firm did not perform process validation and analytical method validation for the drug products (syrups) in question, added the notice.

Propylene glycol, with September 2021 manufacturing date and September 2023 expiry date, was used in the four syrups in question. But the expiry date was mentioned as November 2024 on those syrups.