US Regulator Flags Data Integrity Concerns at Dabur India Manufacturing Facility

Dabur India's US Operations Face FDA Scrutiny Over Manufacturing Lapses

The US Food and Drug Administration (FDA) has flagged significant lapses in data integrity, manufacturing, and maintenance at one of Dabur India's plants following an inspection earlier this year. According to an inspection report, the lapses were identified at the company's factory in Dadra and Nagar Haveli, a western region in India, in January.

Dabur, one of India's oldest and largest consumer goods companies, describes itself as one of the world's largest suppliers of Ayurvedic products with a legacy spanning over 140 years. The company sells a range of over-the-counter and consumer health products in the United States, including cough and cold rubs, antifungal creams, pain relief gels, and oral care products.

The FDA's findings indicate that some units in the facility posed risks of microbiological contamination. Critically, manufacturing records were falsified to conceal that equipment used to make certain products had been used for multiple other products. The report also highlighted the presence of a live bird and bird droppings in the raw material warehouse, approximately 30 feet from packaging materials. Furthermore, an unidentified black substance was observed covering more than 25% of ceiling surfaces in both the raw material warehouse and the finished drug product storage warehouse.

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The FDA's concerns come amid heightened regulatory scrutiny of Indian drugmakers over quality controls for medicines and health products exported to the United States, their largest overseas market. The FDA inspector also raised questions about the reliability of testing at the plant, noting that although microbiology test results were reported as within limits, significant contamination was observed in multiple samples during the inspection.

Dabur has not responded to a Reuters request for comment. Following a Form 483, which is issued after a US FDA inspection, companies typically respond to the regulator with corrective steps taken to address the concerns. The report also highlighted deficiencies in equipment cleaning and maintenance procedures, as well as the failure of management to review drug production and quality records to determine compliance with regulatory requirements before batches were released to the market.