Why US drug regulator has taken action against drugs imported from Dabur India

The US Food and Drug Administration (FDA) has issued an import alert for medicines manufactured following an inspection of Dabur India’s factory in Dadra and Nagar Haveli, the consumer products company said on Thursday.

The action was taken after the FDA inspected the plant and flagged data integrity and maintenance deficiencies.

Why was Dabur flagged?

Last month, Reuters Citing the audit report, it said the regulator found that critical production records were falsified to conceal that equipment meant to produce certain products was being used for multiple other products.

A live bird and bird droppings were found in the raw material warehouse, approximately 30 meters away from the packaging materials.

What does the import warning mean?

A product placed on an FDA import warning may be detained without physical examination unless the importer proves that it has corrected the violations specified in the warning.

Dabur is one of India’s oldest and largest consumer goods companies and describes itself as one of the world’s largest suppliers of Ayurvedic products with a heritage spanning over 140 years. It sells a variety of over-the-counter and consumer health products in the United States, including cough and cold lotions from honey to hair oil, antifungal creams, pain-relief gels, and oral care products.

What was Dabur’s response?

The company said the FDA action had no financial or operational impact, adding that domestic products were not affected by the order.

It said it continues to engage with the US regulator by providing “corrective and preventive action plans” as well as taking action to address identified gaps.

Dabur India share price was trading sideways with a positive trend on Friday morning.