Nature of the Event
Dabur India Limited has submitted information pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015 regarding action taken by the United States Food & Drug Administration (US FDA).
Key Quantitative Figures and Details
The disclosure concerns a Warning Letter received from US FDA regarding the company's manufacturing plant situated at Silvassa, Dadra and Nagar Haveli. The plant was previously inspected by US FDA which identified gaps on account of data integrity and maintenance lapses. Following this inspection and review of the company's responses, US FDA had issued an Import Alert (IA) 66-40 on June 10, 2026, for drugs manufactured by the company at the Silvassa plant.
Dates of Action
- US FDA Inspection: Previously conducted (exact date not specified in this disclosure)
- Import Alert Issued: June 10, 2026
- Import Alert Intimation to Stock Exchanges: June 11, 2026
- Warning Letter Received: July 24, 2026 at 10:03 PM
- Disclosure Date: August 6, 2026
Parties Involved
- Regulatory Authority: United States Food & Drug Administration (US FDA)
- Listed Entity: Dabur India Limited
- Manufacturing Plant: Silvassa, Dadra and Nagar Haveli
- Consulting Firm: Reputed independent US-based compliance consulting firm (name not disclosed)
Remediation Actions Taken
The company has maintained proactive engagement with US FDA and provided four detailed progress updates. Substantial mitigating actions have been completed including:
- Data integrity training across entire manufacturing operations
- Deployment of additional independent resource for continuous review, oversight, and monitoring of data integrity systems & controls
- Closure of all observed infrastructure-related gaps within 30 days
- Comprehensive retrospective risk assessment of impacted processes, systems and products
- Engagement of US-based compliance consulting firm to support assessment, implementation and verification of corrective actions
Financial and Operational Impact
The company states: "There is no impact on financial, operation or other activities of the Company due to this warning notice." The warning notice concerns only a small part of the manufacturing plant in relation to export of private label products, which does not generate significant revenue for the company. Domestic products are not covered and not impacted. The plant continues to be operational for domestic market.
Forward-looking Actions
The company will respond to the warning letter within 15 working days of receipt as part of mitigating actions. The company remains committed to working closely with US FDA and completing remaining actions in accordance with regulatory expectations. Alternative sourcing strategies for US customers have been implemented.
Additional Context
The company emphasizes that multiple internal and external independent third-party testing has shown no out-of-specification or any other concerns with any of company's products. The company states there is no violation/contravention committed or alleged to be committed.