Informist, Wednesday, Aug 21, 2024

MUMBAI – The US Food and Drug Administration asked Aurobindo Pharma Ltd's wholly owned subsidiary Eugia Pharma Specialties Ltd to conduct a six-system audit of their operations at its Unit-III, and even recommended getting third party consultants to look at several issues with the facility. The US regulator had recently sent a warning letter to the company after finding serious lapses during their inspection earlier this year at Eugia Pharma's injectables facility in Telangana, Hyderabad.

According to details of the warning letter posted on the US FDA's website, it has mentioned lapses in data collection related testing, and cleaning and sterilisation practices of equipment. They mentioned that the unit's workers did not properly follow procedures to prevent microbiological contamination of drug products. Among other issues, the regulator was not satisfied with the company's actions to prevent vial breakages during manufacturing of sterile injectable drug products.

The US regulator has asked Eugia Pharma to fix these issues promptly and until these lapses are resolved, the regulator can withhold approval of new applications, the warning letter said.

The regulator asked Eugia Pharma to conduct a detailed investigation to resolve inaccuracies in data records. It said the company should investigate the extent of data inaccuracies and their investigation should include interviews of current and former employees to find the root cause of inaccuracies in data. The regulator recommended getting third party experts to investigate these issues.

The company is required to provide a detailed description of root causes that led to data integrity lapses. It asked the company to have a qualified consultant conduct annual audits for at least two years. It also asked the company to hire a chief integrity officer who would be empowered to receive anonymous complaints from employees related to data integrity concerns.

Apart from this, Eugia Pharma is required to conduct a six-system audit of the facility under review. According to the regulator's guidelines, the six-system inspection model includes checking production, facilities and equipment, packaging and labelling, materials, and laboratory control systems.

The regulator has asked for a detailed action plan to ensure reliability and completeness of all the data. As per the warning letter, Eugia Pharma is required to respond within 15 working days of receiving the letter and specify steps taken to address the above mentioned lapses. Aurobindo Pharma had told exchanges on Friday that they had received the warning letter.

This warning letter comes at a time when Aurobindo Pharma is looking to sell part of its stake in Eugia Pharma by way of an initial public offer, or through any other instrument to unlock the value. Aurobindo Pharma had said in its latest post-earnings conference call that it wants to revive its plan to sell stake in the injectables business arm Eugia Pharma Specialties soon.

Above this, these developments may hurt revenues expected from this facility. During the conference call, the management had said they expect sales of $600 mln for the injectables business for 2024-25 (Apr-Mar).

Today, shares of Aurobindo Pharma closed 1.7% lower at 1,511.50 rupees on the National Stock Exchange. End

Reported by Anshul Choudhary

Edited by Deepshikha Bhardwaj

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