Home HEALTH Maiden Pharmaceuticals: Cough syrup issue: Production halted at Maiden Pharmaceuticals

Maiden Pharmaceuticals: Cough syrup issue: Production halted at Maiden Pharmaceuticals

New Delhi: The Centre formed an expert committee on Wednesday to examine and analyse adverse events reports, causal relationship and related details shared by the World Health Organization (WHO), even as the Haryana health authorities halted all production at Sonipat-based Maiden Pharmaceuticals on the grounds of deficiencies found during a joint inspection by central drug regulatory authority and the state Food and Drug Administration (FDA).

The technical committee formed by the Centre under the chairmanship of pharmacologist YK Gupta will advise the Drugs Controller General of India (DCGI) regarding the future course of action.

“It is important that India’s investigation is done about the traceability and the entire supply-chain system,” Gupta told ET.

State health minister Anil Vij said on Wednesday that 12 flaws were found during the inspection, following which production has been stopped and a notice has been issued to the company.

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As reported by ET on Wednesday, a preliminary report revealed that several violations have been found at the facility. It said that in relation to the cough syrups, it has been found that the company has not done quality testing of propylene glycol for diethylene glycol and ethylene glycol.

The authorities found that the batch number, manufacturer name, expiry date and the manufacturing date on the invoices of propylene glycol used in cough syrups were missing.

Propylene glycol, with a manufacturing date of September 2021 and an expiry date of September 2023, was used in four syrups in question but their expiry date has been mentioned as November 2024, said the report.

Various discrepancies were found during the inspection. “The firm also failed to produce the logbooks of equipment and instruments regarding manufacturing and testing of the products in question,” said the report. It also said that the company did not accelerate stability data of the drugs in question.

The report on the investigation of Maiden Pharmaceuticals in Sonipat, which found deficiencies in several accounts, was submitted to the state health minister on Tuesday, said state drug authority officials.

Controlled samples of the same batch of all the four drugs in question have been taken and sent for testing to the regional drug testing laboratory at Kolkata and the results are awaited.

Soon after the World Health Organization warned that several children have died in Gambia due to the cough syrup made by a local manufacturer, a joint investigation by the central drug regulatory authority and state FDA was done.

After the lapses were found in the investigation, the Central Drugs Standard Control Organisation also sent a show cause notice to the company, which has been asked to file a reply within seven days.