Firm linked with Uzbek cough syrup death, licence cancelled by UP Govt
Uttar Pradesh Drugs Controlling and Licensing Authority has revoked the manufacturing licence of Marion Biotech, a pharmaceutical company located in Noida. This action was taken on Wednesday after their cough syrup, DOK-1 Max, was associated with the deaths of 18 children in Uzbekistan, as per a media report. After an event took place in December of the previous year, the drug regulatory authorities at both the national and regional levels in India launched an inquiry into the matter.
“The healthcare company licence had been suspended since January and a thorough investigation was commenced. Recently, the Uttar Pradesh Drugs Controlling and Licensing Authority has cancelled the firm's licence, which means they are no longer allowed to produce the syrup,” a government official said. According to the official, on 03 March, the Noida Police apprehended three Marion Biotech workers from their office in Sector 67. A lookout notice was issued for two of its directors after an FIR was filed against all of them.
The investigation discovered that the drugs produced by Marion Biotech were not up to standard and had been adulterated, which led to the lodging of the FIR. The FIR stated that after sending the samples to the government’s regional drug testing laboratory in Chandigarh, it was discovered that 22 of them were adulterated and spurious, meaning they did not meet the required standard quality as per norms.
An FIR has been filed against them, citing various offences under the Indian Penal Code, such as Section 274 for tampering with drugs, Section 275 for selling adulterated drugs, and Section 276 for selling drugs as a different drug or medical preparation. Additionally, the FIR mentions violations of Section 17 of the Drugs and Cosmetics Act, of 1940, related to misbranded drugs.
In January, the central and state drug authorities conducted inspections at the company’s site following a controversy, which led to the suspension of the firm’s production license. The World Health Organization (WHO) released a ‘medical product alert’ on January 12, which concerned two flawed (contaminated) products that were discovered in Uzbekistan and reported to the WHO on December 22, 2022.
“Marion Biotech Pvt. Ltd., a manufacturer based in Uttar Pradesh, India, produces two syrups called Ambronol and Dok-1 Max. However, the manufacturer has not yet provided any assurance to the World Health Organization (WHO) regarding the safety and qualities of products,” the WHO officials stated. The Ministry of Health of Uzbekistan has conducted laboratory tests on samples of both products and discovered that they contained an unacceptable level of contaminants such as diethylene glycol or ethylene. Generally, these substandard medical products are toxic to human beings, especially toddlers and may have severe consequences.