NEW DELHI: The United States Food and Drug Administration (USFDA) has accused Mumbai-based drugmaker USV of fudging data, adding to the list of domestic companies such as Ranbaxy Labs andWockhardtBSE 4.41 % that have come under the drug regulator's scanner.
After an inspection of USV's Mumbai laboratory in June, the US drug regulator said the company's "drug product test method validation data is falsified", according to documents reviewed by ET.
USV, one of India's top 20 drugmakers, is the third manufacturer after Mumbai-based Wockhardt and Hyderabad-based Posh Chemicals to be hauled up by the USFDA for allegedly tampering with data in the past three months. However, the most high-profile case of "systemic data falsification" from India remains Ranbaxy's.
While the USFDA sent out letters warning Ranbaxy, Wockhardt and Posh after inspecting their facilities, USV has not yet received a warning letter from the US regulator even as lapses have been communicated in the form of observations. Another difference in USV's case is that the US regulator found violations at this company's testing labs while in the other three cases it found the manufacturing facilities at fault.
"Based on our findings and analyst's own admittance that he modifiedanalytical balance weight print-outs, there is no assurance that the sample and the standard weight values...are representative of the actual weights," the USFDA investigators told USV's managing director Prashant Tewari in an inspectional observation in June. "Analytical balance clocks are modified in order to create falsified weight print-outs that appear to be printed at the time of sample weighing," the investigators said in their damning observations, as per the papers reviewed by ET.
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After an inspection of USV's Mumbai laboratory in June, the US drug regulator said the company's "drug product test method validation data is falsified", according to documents reviewed by ET.
USV, one of India's top 20 drugmakers, is the third manufacturer after Mumbai-based Wockhardt and Hyderabad-based Posh Chemicals to be hauled up by the USFDA for allegedly tampering with data in the past three months. However, the most high-profile case of "systemic data falsification" from India remains Ranbaxy's.
While the USFDA sent out letters warning Ranbaxy, Wockhardt and Posh after inspecting their facilities, USV has not yet received a warning letter from the US regulator even as lapses have been communicated in the form of observations. Another difference in USV's case is that the US regulator found violations at this company's testing labs while in the other three cases it found the manufacturing facilities at fault.
"Based on our findings and analyst's own admittance that he modified
continue to read here