“These 04 drugs are not licensed for manufacture and sale in India. In effect, none of these four drugs is sold domestically,” said a release from the union health ministry.
The manufacturers had been given special approval for export against purchase order placed by Gambia. “These drugs are not sold in India, so the company needed a special approval,” said an official investigating the matter.
Following the death of 66 children in Gambia, the WHO has raised an alert for four India-manufactured fever, cough and cold syrups, urging people to not use them. All the four syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — were manufactured by Haryana-based Maiden Pharmaceuticals.
As per information sent to Indian authorities, the intra-government organisation tested 23 samples of the syrup of which four were found to contain di-ethylene glycol and ethylene glycol, which are toxic for humans and can lead to acute kidney injury and kidney failure in children.
The ministry also urged the WHO to share report on causal relationship — confirmation that the syrups led to the deaths in Gambia — at the earliest. A release from the union health ministry said: “The exact one-to-one causal relation of death has not yet been provided by WHO to CDSCO. As a robust National Regulatory Authority, CDSCO has requested WHO to share at the earliest with CDSCO the report on establishment of causal relation to death with the medical products in question.”
Action against the company
With the products not meant for Indian markets, there weren’t any market samples that could be tested by Indian authorities. A joint team of Central Drugs Standard Control Organisation and Haryana State drug regulator investigating the matter have lifted the controlled samples — samples from the batches sent to Gambia stored by the manufacturers as part of quality control procedures.
The samples have been sent to regional drug testing lab in. According to officials who are part of the investigation in India, even if the control samples are found to be contaminated, the authorities are unsure what action can be taken against the company.
“WHO has shared its findings, but we also have to see whether the control samples contain the contaminants in question. If we do find contaminants, proportionate action will be taken against the company, which may include suspension of the licence to export the drug. However, we are unsure whether we can initiate criminal action against the company because the deaths did not happen in India,” the official said.
The current Drugs and Cosmetics Act has provisions for up to three-year imprisonment, while the proposed Bill has increased this to a minimum of 10 years. In a release, the health ministry said: “It is a usual practice that the importing country tests these imported products on quality parameters and satisfies itself as to the quality of the products before the importing country decides to release such products for usage in the country.”