Data integrity issues have surfaced again, this time at drug-maker Sun Pharmaceutical’s Karkhadi plant in Gujarat.
The US Food and Drug Administration (FDA) has told Sun its initial response on tackling violations involving the documentation of data, among other things, lacked “sufficient corrective actions”.
In its warning letter, sent earlier this month, the US regulator said its inspections last November at the Sun facility had revealed deviations from the current good manufacturing practice (CGMP) in the manufacture of active pharmaceutical ingredients (that go into making a medicine).
“Your firm frequently performs ‘unofficial testing’ of samples, disregards the results, and reports results from additional tests. For example, during stability testing, your firm tested a batch sample six times and subsequently deleted this data,” the regulator said.
Until the issue is sorted out, the regulator said, it could possibly withhold new applications from Sun seeking permission to sell medicines in the US from this plant.
Responding to the development, Sun said: “We had sent our response to the import alert received earlier and given that the facility now has a warning letter, it is clear that the USFDA does not agree with our view. We will be responding in detail in due course on all the matters highlighted in the letter.”
In March, Sun had received an import alert on its cephalosporin facility at Karkhadi, virtually banning all products from the plant from selling in the US.
The USFDA’s latest warning letter comes at a time when Sun seeks to undertake a $4-billion merger with troubled drug-maker Ranbaxy Laboratories.
Incidentally, Ranbaxy had been plagued with serious concerns of data integrity, resulting in the company undertaking a $500-million settlement in the US about two years ago.
Deleting files Outlining Sun’s transgressions, the US regulator said the company had not undertaken adequate investigation into the “pervasive practice of deleting files”.
“The destruction of CGMP records produced by your firm’s manufacturing facility is a serious deficiency that raises concerns about the integrity of all records generated by your firm.
“There was a lack of basic oversight by operations, quality unit, and site managers, as rewriting and destruction of original CGMP records was allowed to persist over a significant period without implementation of systems and controls to prevent data manipulation,” the FDA pointed out.
The USFDA has asked Sun to fix responsibility for the transgressions and hire a consultant to set right procedures. Sun has about two weeks to respond.
Analysts tracking the development point out that the Karkhadi plant’s contribution was negligible to Sun’s overall sales, though delays could creep into the product approval process.
Even as Sun deals with the latest salvo from the USFDA, other drug companies, including Wockhardt and Ranbaxy, are already neck-deep in tackling problem areas highlighted by the US regulator.