USFDA warns Sun Pharma for violating manufacturing standards

MUMBAI India’s largest drugmaker Sun Pharmaceutical Industries Ltd has been warned by US health regulators for violating manufacturing standards at its Halol plant in India, even as it has been working on fixing issues at the plant for over a year. “It is the only site from which we filed injectible products – to that extent I expect Halol to be an increasingly important site for Sun”, he said of the plant that contributed revenues in the “high single digit” percentage of its total sales.

The warning indicates the agency is not satisfied with the remedial measures Sun Pharma has been taking at the plant since last September when the FDA first highlighted issues at the plant after an inspection.

“Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market”, he said.

Dozens of companies in India including some of the largest drug makers are facing warnings and or bans over the previous year, as the agency steps up its inspections of the manufacturing plants located outside the U.S.

To a question from ET, Shanghvi said US FDA’s warning letter for the Halol site do not mandate any third party global audits of Sun’s manufacturing facilities. The focus was to get the site back in compliance, he said, rather than look at transferring other product approvals to other sites.

It further said since the inspection in September 2014, the company has communicated regularly with the USFDA on the progress of its remediation and on issues of product supply.

The company added it is working hard to ensure that the commitments made to the US FDA in September 2014 are fully completed.

Sun Pharma said it was cooperating with the FDA and “willing to undertake any additional steps necessary to ensure that the U.S. Agency is completely satisfied with our remediation of the Halol facility”.

The company did not say when exactly the warning letter was issued. They believe Sun Pharma may have responded to the USFDA inspection observations with some large scale remediation plan and has put in place a remediation process with significant investments into automation and in training to enhance its quality systems and has also engaged external consultants.