US FDA finds Sun Pharma’s response to import ban inadequate

US drug regulator has said that Sun Pharma’s response to the ban on imports of products made at one of the Indian plants lacked ‘sufficient corrective actions’. The American drug regulator 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 May 7, 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 also pointed out issues like failure to exercise appropriate controls over computer related systems and failure to maintain written production, control or distribution records among other issues.

Further, in its warning letter, the regulator said that company’s response was inadequate and it did not conduct an adequate investigation into pervasive practice of deleting files.

“US FDA has said it may withhold approval of any new applications or supplements listing at firm's Karkhadi plant as a drug product or an API manufacturer until all corrections have been completed and US FDA has confirmed corrections of the violations and deviations and Sun's compliance with CGMP. Though the said plant contributes negligible to the overall sales of the company, we believe this feedback can delay the clearance process for the company,” said Sarabjit Kour Nangra, VP Research - Pharma, Angel Broking.

The development comes at a time when Sun Pharma, India’s largest drug maker by market capitalization, is in the process of acquiring Ranbaxy, another Indian pharma company entangled with regulatory bans by the US FDA. Last year Ranbaxy paid $500 million in fine to US after it pleaded guilty to charges of falsifying data and distributing adulterated drugs.

Meanwhile, Sun Pharma is also facing headwinds back home as Andhra Pradesh High Court issued status-quo order on its proposed deal with Ranbaxy due to charges of insider trading in the run up to the public announcement of the deal. Sun Pharma has moved Supreme Court contesting this order saying the state court does not have jurisdiction over the matter as both Sun Pharma and Ranbaxy are based outside its territorial jurisdiction.

The Supreme Court today refused to put a stay on the Andhra HC’s order but asked the state court to decide on the case within two days saying that it would be appropriate for the High Court to hear the matter and decide it before it reaches the apex court.

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