After receiving the complaints of contamination in cough syrup supplied to Uzbekistan, a joint team of Central Drug regulator and Uttar Pradesh Drugs Controlling and Licensing Authority conducted an inspection of manufacturing site of Marion Biotech on December 27, top government sources told Moneycontrol.
"We regret deaths, govt is conducting enquiry. We'll take action as per report. Samples were collected. Manufacturing of that product has been halted as of now & other processes are underway," stated Hasan Raza, Marion Biotech Pharma Company legal head on syrup deaths in Uzbekistan
Sources said that government officials inspected the manufacturing facility till late night and collected the Doc 1-Max cough syrup from the plant.
The samples have been sent for testing contamination as it was done in the case of Gambia.
Inspecting GMP violations
The Assistant Commissioner of Drugs Meerut Division and Drug Inspector, Noida along with two senior officials of CDSCO are part of the team that is investigating this matter. Meanwhile, sources say that a separate team formed by Uttar Pradesh drug regulator is also inspecting the plant for possible GMP violations.
A senior official in the UP drug regulator said they are awaiting the test report for contamination of ethylene glycol and will take stern action if the company is at fault. The official said Doc 1-Mac cough syrup is a Certificate of Pharmaceutical Products (COPP) granted products which were made British Pharmacopeia standard. Marion Biotech's plant in Noida has WHO GMP certification, they added.
Regulator to pay a visit again
The UP-drug regulator official said a state team would again visit the manufacturing site of Marion Biotech in Noida to take a stock of products having propylene glycol.
"Till the time results of the samples are awaited from central laboratory, we would ask the company to completely stop the distribution of all products which have propylene glycol as an ingredient," official added.
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