Rajesh Desai
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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
--
CA. Rajesh Desai