The central Asian nation has put on trial 21 people – 20 Uzbeks and one Indian – for the deaths.
"The firm's licence was under suspension since January after which a detailed inquiry was initiated. Now the licence of the firm has been cancelled by the Uttar Pradesh Drugs Controlling and Licensing Authority. The firm can no longer manufacture the syrup," a government official said.
The drugs regulator has urged state licensing authorities to issue directions to all manufacturers not to use propylene glycol supplied by Maya Chemtech India
Twenty-two out of 36 samples of cough syrups made by the company failed drug contamination tests at a central drug laboratory
All production of drugs and other activities at the firm's campus in Sector 67 in Noida have also been stopped completely, Gautam Buddh Nagar drug inspector Vaibhav Babbar said.
Twenty two out of 36 samples of drugs manufactured by Marion Biotech were found to be contaminated. The state Drugs Controlling and Licensing Authority has started the process of cancellation of manufacturing license of the firm, an official said.
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The Noida police have arrested Marion Biotech’s head of operation Tuhin Bhattacharya, Atul Rawat, the manufacturing chemist, and Mool Singh, the analytical chemist, under various sections of the Indian Penal Code (IPC).
Noida-based firm puts up a strong defence in a letter to central and state drug authorities. Company says it followed British Pharmacopoeia standards while manufacturing two controversial syrups. It also questions the methodology used to find the cause of children’s deaths in Samarkand city of Uzbekistan.
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The firm had not even tested the ingredient properly for the presence of the contaminants diethylene glycol and ethylene glycol, before using it to manufacture the cough syrups.
On December 27, Uzbekistan had said that 18 children may have died after consuming contaminated DOK-1 Max syrup by Marion Biotech. WHO issued a medical product alert for two substandard cough syrups by the Uttar Pradesh-based drug maker on February 12
The World Health Organisation (WHO) has also issued a medical product alert on Ambronol and Dok-1 Max syrups, both manufactured by Marion Biotech in Noida, Uttar Pradesh.
The inspection was ordered after WHO issued ‘medical product alert’ for cough syrups, including the one that was linked to the death of 18 children in Uzbekistan
Marion Biotech had its manufacturing licence suspended after failing to respond to a show-cause notice by the regulatory authority.
The Noida-based firm was given seven days to reply on manufacturing practice violations at its plant, but with a drug sample report awaited, the drug regulator has given additional time to the company to respond to the notice.
Experts point out that laxity on the part of regulators has resulted in substandard and adulterated drugs hitting markets in India and other countries with weak regulatory oversight.
The suspension means that the company's exports will become ineligible for incentives under the Market Access Initiative Scheme.
A spate of allegations that contaminated drugs were being exported to countries with weak drug regulatory mechanisms indicates that larger reforms may be needed
According to the officials involved in the inspection of plants at Noida, a deviation from Schedule M for Good Manufacturing Practices was observed at Marion's plant and the regulators have asked to stop the total production at this unit.
The inspection at Marion Biotech started at around 12 pm and continued for over 10 hours during which six more samples of the syrup were taken, they said.
Two back-to-back cases of cough syrups from India, the first one involving Maiden Pharmaceuticals, which was blamed for supplying contaminated drugs that killed 70 kids in Gambia, have tainted India’s image as the ‘Pharmacy of the World’
Drug authorities have asked the drug maker for an undertaking clarifying whether the Doc-1 Max syrup has been supplied in any part of India
Sources said that government officials inspected the manufacturing facility till late night and collected the Doc 1-Max cough syrup from the plant. Hasan Raza, Marion Biotech Pharma Company legal head also mentioned that the product has been halted.