FIR against Noida-based pharma over death of children in Uzbekistan; 3 arrested

A joint team of the Central Drugs Standard Control Organisation (CDSCO) and Uttar Pradesh drug authorities after testing the drug found its product samples “adulterated and not of standard quality.”

Based on a complaint filed by the drug control department on Thursday regarding the sale of adulterated and spurious products by the Noida-based pharmaceutical company Marion Biotech, police on Friday arrested three persons in connection.

The case is linked to the death of 18 children in Uzbekistan in December last year after the country alleged that the children died after consuming Dok-1 cough syrups (Representative Photo)

The case is linked to the death of 18 children in Uzbekistan in December last year after the country alleged that the children died after consuming Dok-1 cough syrups manufactured by Marion Biotech. Amid the allegations, a probe was launched.

A joint team of the Central Drugs Standard Control Organisation (CDSCO) and Uttar Pradesh drug authorities after testing the drug found its product samples “adulterated and not of standard quality.”

The arrests were made after a first information report (FIR) was lodged against five officials of the company, including the two directors.

The arrested accused were identified as Tuhin Bhattacharya, head of the operation, manufacturing chemist Atul Rawat, and analytical chemist Mool Singh.

“Three persons named in the FIR were arrested on Friday from the premises of the company in Sector 67, while the two directors of the company are at large,” said additional deputy commissioner of police (Central Noida) Rajiv Dixit, adding the couple Jaya Jain and Sachin Jain, the two directors of the firm, are absconding.

Vijay Kumar, station house officer (SHO), Phase 3 police station, said an FIR was registered under Indian Penal Code (IPC) sections 274 (adulteration of drugs), 275 (sale of adulterated drugs), 276 (sale of drug as a different drug or medical preparation) as well as under Section 17 (misbranded drugs) and related violations of the Drugs and Cosmetics Act, 1940.

CDSCO in its complaint stated that central and state drug authorities checked samples from Marion Biotech’s drugs during joint inspections on December 27, 29 and 30, 2022. These were sent to the government’s regional drug testing laboratory in Chandigarh, and 22 of the samples were found to be ‘not of standard quality’ (adulterated and spurious).

“As per sections 17A and 17B of the Drugs and Cosmetics Act, 1940, adulterated and spurious drugs can cause grievous hurt to the public. It is suspected that the related material/records may be disposed of by the firm and accused persons,” states the complaint.

During the inspection in December, the company representatives could not produce documents related to the production of ‘Dok-1 max’ cough syrup, prompting the government to order the halting of its production immediately, Gautam Budh Nagar’s drug inspector Vaibhav Babbar said.

He added that the production licence of the firm was suspended in January this year. Officials informed that Marion Biotech did not sell the cough syrups, ‘Dok-1 Max’ and Ambronol, in India and its only export has been to Uzbekistan. The company stopped production of cough syrup after the case came to light.

Meanwhile, the company was also found defaulting on schedule M-good manufacturing practices (GMP) in production, a certification standard.

The World Health Organisation (WHO) issued a ‘medical product alert’, referring to two substandard (contaminated) products identified in Uzbekistan and reported to WHO on December 22, 2022.

The WHO statement added that the samples of both products tested by the ministry of health of the Republic of Uzbekistan found both products contained ‘unacceptable amounts of diethylene glycol and/or ethylene glycol as contaminants’.

It further mentioned that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.

Diethylene glycol (DEG) and ethylene glycol (EG) are highly toxic, colourless and viscous liquids which are popularly used in industrial products such as paints, stationery ink, brake fluids and antifreeze.

According to the Centers for Disease Control, DEG and EG are often found as contaminants in glycerin, which is used as a sweetener in many pharmaceutical syrups taken orally. Both these chemicals are highly toxic.