New Delhi: The investigation into claims that a state drug regulator in India took bribes to tamper with cough syrup samples that may have been connected to children's deaths in the Gambia is nearing completion, according to Reuters, which cited people with knowledge of the case on Friday.
Seventy children in the Gambia died last year, and the World Health Organisation (WHO) linked the cough syrups made in India by Maiden Pharmaceuticals to their fatalities. However, the Indian government disputes this, pointing to studies carried out at a government laboratory that reportedly claimed that the syrup was non-toxic.
Indian authorities had opened an investigation on the basis of claims that a regional pharmaceutical regulator had participated in the sample switching in exchange for bribes. The WHO first connected these samples to child fatalities in the Gambia. There are allegations under investigation that the samples were altered prior to testing.
Maiden Pharmaceuticals denied any misconduct, India Today reported.
Maiden Pharma has been found in violation of the law on previous occasions. It was discovered that the very high concentrations of ethylene and diethylene glycol in four of its cough syrups cause kidney damage. Even after breaking numerous rules, the business was permitted to continue operating.
Keralan officials found that the company's products were at least five times "substandard" in 2021 and 2022. Among these were metformin pills, a medication for type 2 diabetes, which could not pass the dissolve test. An excess of aspirin was present in another drug.
Similarly, in 2015, the authorities in Gujarat discovered that some Macipro samples—a medication that contains the antibiotic ciprofloxacin—did not meet the specified requirements.
Following the discovery of six batches of the company's two medications to be "substandard," the Bihar health department placed Maiden on a five-year blacklist in 2011. It was apparently discovered that one medicine batch was spurious.
The company was prosecuted in 2018 by an Indian government drug inspector for quality violations under the Drugs & Cosmetics Act. Maiden was one of 39 businesses that Vietnam placed on a blacklist in 2014 for violating Quality Control Regulation and Drug Regulation