Dabur downplays USFDA warning, says India business unaffected; Silvassa plant continues operations
Dabur India on Thursday said its domestic business remains unaffected despite receiving a warning letter from the US Food and Drug Administration (USFDA) over manufacturing
Dabur India on Thursday said its domestic business remains unaffected despite receiving a warning letter from the US Food and Drug Administration (USFDA) over manufacturing deficiencies at its pharmaceutical facility in Silvassa. The company also confirmed that the plant continues to operate while it works with the regulator to address the observations. The FMCG major said it has submitted a revised response to the USFDA outlining corrective measures to resolve the issues identified during the inspection. "The Silvassa plant continues to be operational. This order concerns only a small part of our plant in relation to private label, which generates insignificant revenue for the company. Moreover, production of some part has already been shifted to our Baddi facility, and we do not anticipate any significant disruption to operations or business performance," Dabur’s Global CEO Mohit Malhotra said. Quick answers to key questions • 5 QUESTIONS 1 What were the main concerns raised by the USFDA regarding Dabur's Silvassa plant? ⌵ The USFDA identified significant violations of Current Good Manufacturing Practices (CGMP) at Dabur's Silvassa plant, including data integrity concerns, inadequate quality management, and deficiencies in manufacturing controls. 2 How is Dabur addressing the USFDA's warning about its Silvassa facility? ⌵ Dabur is working with the USFDA to address the deficiencies by submitting a revised response that outlines corrective actions, which include employee retraining and improved documentation practices.
3 Why did the USFDA classify products from Dabur's Silvassa facility as 'adulterated'? ⌵ The USFDA deemed products from the facility 'adulterated' because the manufacturing methods and controls failed to meet CGMP standards, leading to concerns over product quality and safety. 4 What impact did the USFDA's Import Alert 66-40 have on Dabur's operations? ⌵ The Import Alert 66-40 placed all drugs and pharmaceutical products manufactured at the Silvassa facility under scrutiny, restricting their import into the U.S. market and requiring Dabur to appoint an independent consultant to review its practices. 5 How is the Indian government's regulation of pharmaceutical companies evolving in light of incidents like Dabur's USFDA warning? ⌵ The Indian government is strengthening its regulatory framework by implementing measures such as debarment from filing applications for companies that submit fake data, aiming to enhance drug safety and accountability in the pharmaceutical sector. Also Read | Why US drug regulator has taken action against drugs imported from Dabur India The USFDA issued the warning letter after identifying significant violations of Current Good Manufacturing Practices (CGMP) at the company's pharmaceutical manufacturing unit in Silvassa. The action follows an inspection carried out at the facility between January and 16 December 2026. In its letter dated 24 July 2027, addressed to Malhotra, the regulator cited multiple deficiencies, including data integrity concerns, inadequate quality management and shortcomings in manufacturing controls.
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