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 The official at the Central Drugs Standard Control Organization (CDSCO),
who declined to be named citing the sensitivity of the matter, said
a written order had been sent to the U.S. company telling it to stop
using the "huge quantities" of raw materials stocked in its plants
in northern and western India.
Read the Reuters investigation https://reut.rs/2rAz2TO
The company said on Wednesday that Indian drug authorities visited
some of its facilities and took "tests and samples" of its talcum
powder. It also said that the safety of its cosmetic talc was based
on a long history of safe use and decades of research and clinical
evidence by independent researchers and scientific review boards
across the world.
The CDSCO also collected samples of the company's baby shampoo and
soap products as a matter of routine, the official said.
"Whenever inspectors feel there is contamination in one thing they
also take samples of (other products) from the same company," the
official said.
The visits came as the CDSCO and state-based food and drug
administrations launched an investigation into J&J's Baby Powder
following a Reuters report last Friday that the firm knew for
decades that cancer-causing asbestos could be found in the product.
J&J has described the Reuters article as "one-sided, false and
inflammatory".
The company told Reuters that it is in full compliance with the
current Indian regulatory requirements for the manufacturing and
testing of its talc.
"All talc in India is sourced and exclusively sold in India and
surrounding markets – including Sri Lanka, Bangladesh, Nepal,
Bhutan, Maldives – and fully meets the regulatory standards of the
Government of India," the company said in an emailed statement.
J&J also said its talc is routinely tested by both suppliers and
independent labs to ensure that it is free of asbestos.
Asked if the order meant the company would have to stop producing
its ubiquitous Baby Powder in India for now, the official at the
drugs regulator said that was "the inference you have to take" at
least as far as the stores of raw materials were concerned.
"We have told them until this investigation concludes, you should
not use the raw material. Test results will take time," the official
said. "Testing for asbestos is not a routine procedure. It might be
in traces. It will require us to develop a method and all those
things."
FAMILIAR BRAND
J&J's Baby Powder is one of the most recognized foreign brands in
India.
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The company started selling its Baby Powder in India in 1948, just a
year after the country won independence from Britain. Presenting
gift boxes containing the product and others aimed at newborns is
almost a family ritual in this country of 1.3 billion people, 28
percent of whom are aged 0-14.
The company also commands a strong retail distribution network
through small pharmacies, larger stores and the internet.
There is yet to be any significant signs of a backlash against J&J
products in India. At eight pharmacies across India visited by
Reuters reporters on Thursday, seven said J&J remained the No. 1
seller of powder for babies.
That doesn't mean it isn't under pressure from local and
international competitors who sell talc-type powders, such as
Bengaluru-based Himalaya Herbals, and Italy's Artsana, which
produces Chicco baby brands.
And some individual consumers say they are now very wary of J&J's
Baby Powder.
"It is really very, very shocking," said Sitaram Beria, a chartered
accountant in the eastern city of Bhubaneswar. He said he stopped
applying J&J powder to his six-month old baby after hearing about
the Reuters report over the weekend.
J&J leads sales in the Indian baby and child toiletries market,
which market research provider Euromonitor estimates would be worth
12.5 billion rupees ($178 million) this year, and forecasts will
grow 84 percent to 23 billion rupees in 2022.
Euromonitor did not give a breakdown for baby powder alone but said
J&J was the biggest player in the overall segment, followed by
Mumbai-based VVF Ltd, Artsana, Wipro of Bengaluru and Himalaya.
Himalaya said in a statement that its herbs-based baby care products
"are exclusively promoted and recommended by over 40,000 doctors in
the country, which is the greatest endorsement for us," while
declining to provide any financial figures.
The other companies could not be reached for comment.
(Reporting by Krishna N. Das, Rahul Singh; Additional reporting by
Saumya Sibi Joseph in Bengaluru; Editing by Keith Weir and James
Emmanuel)
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