FDA warning points to infrastructure issue in India

The leaders of some Indian drugmakers like Biocon and Cipla have complained about failing infrastructure that leaves power and water supplies uncertain in that country, creating obstacles for manufacturing. A recent warning letter to an API maker in Mumbai illustrates the impact that can have.

According to the letter posted this week on the FDA website, two plants operated by Aarti Drug recorded 130 power interruptions during processing in 2012. The backup power source at one plant would not kick in automatically, and so an employee would have to go turn it on. But not once did it occur to managers at the plants that the outages might affect samples in the quality-control stability chamber. In the warning letter, the FDA told the company that in the future, it wants an investigation into the potential impact every time the power goes out.

The observation is just one of a number of serious violations the FDA noted at the two Aarti plants during inspections last year. Employees also noted completion times in batch records for processes that hadn't finished, and tests were run based on experience rather than written procedures. The FDA said required raw data was missing from some test reports and the audit trail function on chromatographic systems had been disabled so it couldn't be collected. Computers were not protected from data loss or alteration without any trace of how or when it happened. The warning letter says the company's quality-control laboratory documentation practices don't give the agency any assurance that test results are reliable. "It is apparent that you have not implemented a robust quality system at your firm," the letter said.

The letter is only one of many that manufacturers in India have received lately. The FDA is in the process of expanding its office there, and a new top official has been put in place as it tries to get on top of manufacturing issues in a country that provides an estimated 10% of U.S. drug products.

The power outages, and the warning letter, illustrate what both Indian manufacturers and the FDA face in that country. Some Indian drugmakers have said that the lack of a dependable infrastructure there has led them to build some new plants in other countries. Biocon has a $200 million plant being completed in Malaysia that it built there for that reason. "We don't have enough power. We don't have enough water," Kiran Mazumdar-Shaw, head of the company, told Reuters recently. "So some of these projects where we need water and power, I will do it in Malaysia because that's where it is abundant."

- read the warning letter

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