Dabur gets US FDA import alert

The products mentioned were part of an unauthorised export by an independent trader without any consent or knowledge of Dabur India Ltd, the company said in a statement.

The US Food and Drug Administration (FDA) has imposed an import alert on Dabur India’s two manufacturing facilities in Himachal Pradesh.

The alert was placed after unapproved products from these facilities were found in the US market. The products in question include Dabur’s Meswak toothpaste, manufactured at its Baddi facility, and fairness cream bleach, made at the company’s unit in Nalagarh, according to the import alert posted on the US regulator’s website.

Dabur India said the products “seem to be part of an unauthorised export by an independent trader, without any consent or knowledge” of the company and it had already taken up the matter with the FDA.

A company spokesperson claimed Dabur did not export these products from India to the US. “Indian companies regularly get such alerts from authorities in the US and other developed countries. Based on these alerts, we prepare a dossier and submit relevant information to the authorities within the stipulated time, after which these matters are resolved,” the spokesperson told Business Standard.

Dabur sells many leading brands in the US from its portfolio, including hair oil and shampoo under the Vatika and Amla brands. It also sells Meswak in the US. However, the company official clarified, most of these products, including Meswak, are sourced from Dubai. “The products have been detained in the US because the batches were manufactured in our facilities in India, which are not registered there,” the official said.

Revenue contribution from the US market to Dabur’s consolidated sales is insignificant, said the official. “It is a very small market for us and sales are insignificant in our total numbers.”

Dabur is the third Indian company to come under the US FDA scanner in a month. In May, the regulator placed an import alert on Wockhardt’s drug manufacturing facility in Waluj. Pharmaceutical company RPG Life Sciences received a warning letter for violations of norms at manufacturing units in Ankleshwar and Navi Mumbai. Ranbaxy had earlier pleaded guilty in the US for making fraudulent statements to the regulator to gain drug approvals. It also paid a penalty of $500 million to settle issues with the US Department of Justice.

RAISING THE RED FLAG

* US FDA imposes import alert on Dabur India’s Baddi and Nalagarh facilities in Himachal Pradesh

* Import alert based on detention of unapproved products in the US

* Detained products include Meswak toothpaste with pure extract of rare herb, fairness cream bleach and fairness cream bleach with Gulabari

* Dabur says products seem to be part of an unauthorised export

* Dabur ‘s leading brands in the US, including Vatika, Amla and Meswak, sourced from Dubai

* US sales insignificant says Dabur