World Health Organization (WHO) issued an alert on Wednesday regarding four syrups, but Indian authorities investigating the matter said the products were only sold in the Gambia.
There is no license to manufacture and sell these four drugs in India. As a result, none of these four drugs is available on the domestic market,” according to a release issued by the ministry of health.
The manufacturers had been granted special approval for export in response to a purchase order placed by the Gambia. The company required special approval from the government to sell these drugs in India, according to an official investigating the matter.
The World Health Organization has issued an alert about four fever, cough, and cold syrups made in India, urging people not to use them. All four syrups were manufactured by a Haryana-based pharmaceutical company, Maiden Pharmaceuticals – Promethazine Oral Solution, Kofexmalin Infant Cough Syrup, Makoff Infant Cough Syrup, and Magrip N Cold Syrup.
As per information sent to Indian authorities, 23 samples of the syrup were tested by the intra-government organization, of which four were found to contain diethylene glycol and ethylene glycol, both toxic to humans and capable of causing acute kidney injury or kidney failure in children.
The ministry also urged the WHO to share the report on the causal relationship – confirmation that the syrups caused the deaths in the Gambia – as soon as possible. According to a press release issued by the union health ministry, WHO has not yet provided CDSCO with the precise one-to-one causal relation of death. A robust national regulatory authority, CDSCO has requested WHO to share with it the report on establishing a causal connection between the medical products and death.”
Taking legal action against the company
Because the products were not intended for Indian markets, there were no market samples available for testing by Indian authorities. A joint investigation team of the Central Drugs Standard Control Organisation and the Haryana State Drug Regulatory Authority has taken control samples from batches sent to Gambia and stored by the manufacturers as part of quality control procedures.
A regional drug testing lab in Chandigarh has been notified of the samples. Indian officials involved in the investigation say they are uncertain what action can be taken against the company even if the control samples are contaminated.
“The WHO has shared its findings, but we will also need to examine whether the control samples contain the contaminants in question. Should contaminants be found, we will take proportionate action against the company, including suspending its export license. As far as criminal action is concerned, we are uncertain whether we can take action against the company since the deaths did not occur in India,” said the official.
A violation of the Drugs and Cosmetics Act currently carries a maximum sentence of three years in prison. The proposed Bill increases this maximum sentence to a minimum of ten years in prison.
As stated in the release by the health ministry: “It is a standard practice for importing countries to test these imported products on quality parameters and satisfy themselves as to the…Several factors must be taken into account before the importing country decides to release such products.