US FDA warns Sun Pharma over manufacturing practices at Karkhadi plant

Drug-maker Sun Pharmaceutical's Karkhadi plant in Gujarat has once again been hit with data integrity issues. 

The US Food and Drug Administration (FDA) told Sun its initial response on tackling violations involving the documentation of data, among other things, lacked ''sufficient corrective actions''.

The regulator, in its warning letter sent earlier this month during its inspection at the Sun facility, said deviations from the current good manufacturing practice (CGMP) in the manufacture of active pharmaceutical ingredients (that go into making a medicine) had come to light.

''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.

The regulator added, until the issue was sorted out, it could possibly withhold new applications from Sun seeking permission to sell medicines in the US from the plant.

In response 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.''

The US FDA had banned imports of drugs made at Sun Pharma's Karkhadi plant in Gujarat in March this year.

In a letter addressed to Subramanian Kalyanasundaram, CEO of Sun Pharma, dated 7 May, US Food and Drug Administrator (US FDA) said, ''Your firm is missing the fundamental raw data and information necessary to document your analyses. Also, your company performs ''unofficial testing'' of samples, disregards the results, and reports results from additional tests.''

The regulator pointed to several other issues like failure to exercise appropriate controls over computer related systems and failure to maintain written production, control or distribution records among other issues.

It added the company's response was inadequate and that it had failed to conduct an adequate investigation into pervasive practice of deleting files.

The development comes at a time when Sun Pharma, India's largest drug maker by market capitalisation, was in the process of acquisition of Ranbaxy, another Indian pharma company faced with regulatory action by the US FDA.

Ranbaxy last year paid $500 million in fine to US after pleading guilty to data falsification and distribution of adulterated drugs (See: Ranbaxy fined $500 mn by US regulator over drug safety lapses).