NEW YORK: US Food and Drug Administration (FDA) officials found multiple faults at a plant operated by one of India’s biggest drugmakers as the watchdog continues to find wide-ranging lapses across the indian factories while working through a Covid-19 pandemic-era inspection backlog.
Auditors unearthed deficient manufacturing equipment, cleaning and storage control system during a visit in May to an Aurobindo Pharma Ltd. facility in Anakapalli, India. Sampling tools were not properly cleaned and maintained to avoid contamination at the facility, which manufactures certain active pharmaceutical ingredients — the raw materials vital to making drugs, according to Bloomberg.
Laboratory control system also did not include the establishment of scientifically strong and appropriate specification, made to assure that medicine products conform to appropriate standards of purity, identity, and quality.
During a warehouse inspection, the officials also witnessed that raw materials being stored in extremely hot and humid conditions and not compliant with label storage conditions.
Indian drug-manufacturers face adverse audits
Indian drug manufacturers have faced a wave of adverse audits this year as the United States agency races through over 1,000 foreign drug-plant inspections that were missed due to travel restrictions during pandemic. Despite an uptick last year, factory visits were still down 74 percent from 2019’s level.
India’s 50 billion dollars drug-making industry, which Prime Minister Narendra Modi has boasted as the pharmacy of the world, is also under strict scrutiny after a number scandals, including the deaths of dozens of children in Uzbekistan and Gambia from adulterated cough syrup.
The issues in Indian factories have rippled to the United States, which heavily depends on supplies of cheap generic medicines from India. Plant shutdowns, extra testing, and recalls has seen the number of drugs in short supply hit a 5-year high.
Headquartered in the pharmaceutical hub of India, Hyderabad, Aurobindo was established in 1986 by P.V. Ramprasad Reddy and K. Nityananda Reddy as a manufacturer of semi-synthetic penicillin. It has since expanded to become an exporter of medicines to more than 150 countries and makes 90 percent of its roughly 3 billion dollars annual revenue from international markets. It gets about 15 percent of its sales from APIs.
