A preliminary report prepared by India’s apex drug regulator in collaboration with Haryana’s state drug authorities has underlined major violations in good manufacturing practices (GMP) by Maiden Pharmaceuticals, the company in the dock for allegedly supplying adulterated cough syrup to Gambia.
The report by the Central Drugs Standard Control Organization (CDSCO) has now been submitted to the Union health ministry and has also been sent to the Prime Minister's Office, even though the results from the samples sent for investigating into the contamination of the suspected batches of medicine is still awaited, four government sources intimately aware of the matter have confirmed to Moneycontrol.
Moneycontrol has reviewed a copy of this report.
The World Health Organization (WHO), last week, had issued alerts on four cough syrups by the Haryana-based drug maker that were purportedly behind killing at least 66 kids in Gambia.
The report is based on the inspections carried out by the CDSCO and Haryana drug regulatory authorities in the manufacturing plants of Maiden Pharmaceuticals in Kundli and Sonepat in Haryana last week and highlights issues such as irregularities in documentation as well as lack of evidence for testing for contamination in ingredients used in the drugs.
The WHO had mentioned that it was the presence of contaminants such as Diethylene Glycol (DEG) or Ethylene Glycol (EG)—which is sometimes present in propylene glycol used as a solvent in medicinal syrups—that may have killed the children.
DEG and EG, beyond a very miniscule limit can cause symptoms such as acute kidney failure and may be fatal, especially for kids with low body weights.
“There are evidences of shocking lapses in maintaining GMP standards on the part of the manufacturer and necessary action would be initiated against it once the lab test results are received,” said a government source.
V G Somani, Drug Controller General of India, however, was not available to comment on the CDSCO’s observations in the report. Moneycontrol also tried to reach out to Maiden Pharma's Director Naresh Kumar Goyal seeking his views on the official observation but he did not pick calls. We will update this story as and when they respond.
Faults in procedure, processes
An official attached with Haryana food and drug administration department said that the company, during the inspections, failed to provide proper log books of equipment and instruments regarding manufacturing and testing for the drugs prepared for export to Gambia.
Also read: How Maiden and other Indian pharma firms exploited WHO certification process
During the inspections, it was also found that there were discrepancies in the batch numbers of propylene glycol and other solvents used in manufacturing of the cough syrups when compared to the certificate of analysis report of the syrup—which is prepared for every batch of product, the report has said.
“There are multiple issues with the way drugs were being prepared at the plants and unfortunately it may not have been limited to flagged drugs but other drugs prepared at the units as well,” said a CDSCO official, citing anonymity.
The Centre, meanwhile, is also waiting for the causality assessment report from the WHO that it had sought on Gambian deaths.
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