FDA says USV fudged ‘drug product test method validation data’; also pulls up co over staff training

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 and Wockhardt that have come under its 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 Mumbaibased Wockhardt and Hyderabad-based Posh Chemicals to be hauled up by the US drug regulator for allegedly tampering with data in the past three months.

The most high-profile case of "systemic data falsification" from India, however, remains that of Ranbaxy, which culminated in a $500-million fine for the company in May 2013 after seven years of investigation. While 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 analytical balance weight print-outs, there is no assurance that the sample and the standard weight values…are representative of the actual weights," USFDA investigators told USV 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.

The US regulator has also reprimanded USV for not training its staff in current good manufacturing practices.

Admitting that the company had received adverse inspectional observations from FDA at its testing lab, USV chief operating officer Debabrata Gupta told ET that the company expected a successful resolution shortly.

"We have taken suitable corrective actions in consultation with US-based consultants and have responded to USFDA appropriately on the Form 483 observations on July 1, 2013," Gupta said.

Form 483 is the first stage of objections that investigators from FDA issue immediately after inspections if they find violations at a manufacturing site or a testing lab. If the company fails to resolve or respond satisfactorily to these adverse comments, the regulator can issue a warning letter or an import alert, and thereby, bar the entry of drugs from the affected facilities into the US.

An analyst, who did not wish to be named, said the adverse observations were unlikely to have any significant impact on the revenues of the unlisted drug firm. "But the next few months would be critical to see whether the firm manages to convince FDA that it has successfully addressed all issues raised in 483," added the analyst, who works with a brokerage firm.

USV clocks annual sales of about . 1,200 crore and has a target of topping . 2,000 crore by 2015. Its finished products are marketed in the US, the EU and Africa, among other regions.

Over the past three and a half months, India-based facilities, including those belonging to MNCs, have received over eight warning letters from the US drug regulator. As reported by ET last month, this constitutes the biggest chunk sent out to any country globally by the Centre for Drug Evaluation and Research, an arm of USFDA, responsible for drug safety. This rate, of a red flag roughly every fortnight, is much higher compared to the warning letters that facilities in India have received over the past three years.