US Food and Drug Administration (FDA) found multiple faults at a plant run by one of India’s biggest drugmakers Aurbindo Pharma. Auditors uncovered deficient manufacturing equipment cleaning and storage controls during a visit last month to the pharmaceutical company facility in Anakapalli, says reports.
According to a FDA report obtained by Bloomberg News through a Freedom of Information Act request. Sampling tools weren’t cleaned and maintained to prevent contamination at the plant, which produces certain active pharmaceutical ingredients — the raw materials core to making drugs.
Laboratory controls didn’t include the establishment of scientifically sound and appropriate specification, designed to assure that drug products conform to appropriate standards of identity, quality and purity, the report said. During a warehouse walk-through, the auditors also observed raw materials being stored in excessively hot and humid conditions and not compliant with label storage requirements.
Aurobindo, India’s second-largest drugmaker by revenue, didn’t respond to a request for comment from Bloomberg News about the FDA’s report. In a statement last month, Aurobindo Pharma said the FDA recorded “procedural” observations following the inspection of its factory in Anakapalli in May. While the company didn’t give details on the observations, it said it was working to address them and will respond to the FDA.
The FDA typically waits to receive a company’s plan to address issues before deciding on next steps. The Anakapalli factory produces APIs for cardiovascular and anti-fungal treatments, according to a presentation to investors in August. Indian drugmakers have faced a wave of adverse audits this year as the agency races through more than 1,000 foreign drug-plant inspections that were missed due to travel restrictions during Covid. Despite an uptick in 2022, factory visits were still down 74% from 2019’s level.
India’s US $50 billion drug-making industry, which PM Narendra Modi has referred to as the ‘pharmacy of the world’, is also under heightened scrutiny after a number manufacturing scandals, including the deaths of dozens of children in Gambia and Uzbekistan from adulterated cough syrup. The problems in Indian factories have rippled to the US, which largely depends on supplies of cheap generic drugs from the South Asian nation.
According to the report, plant shutdowns, recalls and extra testing has seen the number of medications in short supply hit a five-year high. But the inspection reports from the FDA signal the shortage may worsen, ramping up pressure on the White House task force formed to tackle quality problems in the supply chain.
The problems in Indian factories have rippled to the US, which largely depends on supplies of cheap generic drugs from the South Asian nation. Plant shutdowns, recalls and extra testing has seen the number of medications in short supply hit a five-year high. But the inspection reports from the FDA signal the shortage may worsen, ramping up pressure on the White House task force formed to tackle quality problems in the supply chain.
HealthTekPak could not reach Aurbindo Pharma for an official quote.
