Top Indian drugmaker under scrutiny as FDA finds faults at factory

Officials of the the US Food and Drug Administration (FDA) have detected numerous faults at a factory operated by Aurobindo Pharma Ltd., one of India's largest pharmaceutical companies, Bloomberg reported.

This comes as the FDA is scrutinising considerable shortcomings in India's factories amidst a backlog of inspections due to the Covid-19 pandemic.

According to an FDA report obtained by Bloomberg News, auditors found inadequacies in the cleaning and storage of manufacturing equipment during their visit to an Aurobindo facility in Anakapalli, eastern India, last month. There were also issues with the cleaning and maintenance of sampling tools, raising concerns about contamination at the plant which manufactures certain active pharmaceutical ingredients—the essential raw materials in drug production.

In addition, the laboratory's controls were found lacking in establishing scientifically sound and suitable specifications to guarantee that drug products comply with the necessary identity, quality, and purity standards.

The FDA report highlighted that during a warehouse tour, auditors noted raw materials stored in extremely hot and humid conditions, not meeting label storage requirements.

Also read 'Indian firm used toxic industrial-grade ingredient in syrup'

Aurobindo, India's second-largest drugmaker by turnover, has not responded to a request by Bloomberg News for comment on the FDA report. However, in a statement last month, the company noted the FDA had made "procedural" observations during its factory inspection in May, pledging to address these concerns and respond to the FDA accordingly.

Following the revelation, Aurobindo's shares dipped sharply by 1.5% on Friday.

Indian pharmaceutical companies have come under increased scrutiny due to numerous adverse audits this year as the US agency tackles a backlog of over 1,000 foreign drug-plant inspections, missed because of Covid-19 travel restrictions. Despite an increase in 2022, factory visits are still down 74% from 2019's level.

India's $50 billion drug-manufacturing industry, hailed as the "pharmacy of the world" by Prime Minister Narendra Modi, is facing enhanced scrutiny in light of several manufacturing scandals, including the tragic deaths of dozens of children in Gambia and Uzbekistan due to contaminated cough syrup.

The issues with Indian factories have had repercussions in the US, which relies heavily on the supply of inexpensive generic drugs from India. Plant closures, product recalls, and additional testing have led to a five-year high in medication shortages. The FDA's inspection reports hint at a potential worsening of this shortage, increasing pressure on the White House task force formed to address quality issues in the supply chain.

Aurobindo, headquartered in the Indian pharmaceutical hub of Hyderabad, was established in 1986 as a producer of semi-synthetic penicillin. The company has since expanded and now exports drugs to over 150 countries, with international markets accounting for 90% of its approximate $3 billion annual revenue.