powder sales | India News –
Last week pharma behemoth Johnson & Johnson (J&J) announced that it would
discontinue the sale of its talc-based baby powder globally from 2023. The
company faces thousands of lawsuits from women who have alleged that the
talc contains asbestos and causes cancer.
The company said that it had made a “commercial decision” to transition to a
cornstarch-based baby powder.
There is an Indian ‘push’ to J&J’s decision to discontinue the manufacture and
sale of its talc-based baby powder. Eight years ago, India was the first country
that raised concerns over J&J baby talc powder being sterilised by ethylene
oxide, a known carcinogenic.
While ethylene oxide can be used for sterilisation, the company did not bother to
carry out tests to check the amount of residue in the product.
The man who took on the pharma giant was Mahesh Zagade, then the
commissioner of Maharashtra’s Food and Drug Administration (FDA).
On August 12 he tweeted, “I was the first in the world to cancel manufacturing
licence of JnJ’s baby powder for their criminality of usage of carcinogenic
material. This was done 8 years ago.”
In the cross hairs
Zagade, who had joined the FDA in August 2011, started off with a crackdown on
major pharmaceutical companies, besides chemists and pharmacists functioning
illegally. However, the action against the giant pharmaceutical company J&J
reverberated globally and a team of the USFDA flew down to Mumbai to
investigate matters resulting in a big setback to the company.
In an exclusive interview to TOI+, Zagade, a former Indian Administrative Service
(IAS) officer says that cancelling a licence of a giant pharma company was not
easy and he had to face immense pressure from his superiors to politicians, from
being offered bribes to being threatened.
“At the end of the day, what matters is the safety of the people. Playing with
human lives is totally unacceptable,” he says. Recalling the events leading up to
the cancellation of J&J’s licence, Zagade, who took over as FDA commissioner in
August 2011, says that as he was new to the job, he was going through various
complaints and reports. “I came across a report on Johnson and Johnson. My
officers told me that it dated back to 2007 when they found that 15 batches
which included 1,60,000 bottles of Johnson & Johnson baby powder were
sterilised by ethylene oxide, a known carcinogenic and irritant.”
According to the report, the particular batches were outsourced to a company in
Thane for sterilisation. The Thane company sterilised with ethylene oxide for
which the standard operating process was not submitted to FDA. Before sending
it to Thane, J&J should have taken the permission of FDA which they had not
taken, he says.
“Ethylene oxide is used in hospitals to sterilise equipment. There was no reason
why the J&J had used such a strong chemical to sterilise baby powder boxes. I
was shocked that no action had been taken despite knowing the facts. While
investigating we found that J&J continued sending the batches to the Thane firm
for sterilisation,” says Zagade.
He decided to probe the matter and spoke to experts who told him that if
children are exposed to ethylene oxide then chances of them getting cancer is
high. “I was convinced that it was a serious matter and we couldn’t sweep it
under the carpet. So in April 2013 I asked the joint commissioner to cancel the
licence of J&J’s Mulund plant,” he says.
It wasn’t a simple matter, Zagade recalls. The order had to properly drafted after
taking advice from lawyers because J&J would surely move the courts. It was
probably the first time that the FDA was cancelling the licence of a large
“After serving the notice to shut down the Mulund plant, the same day I went to
meet FDA minister Manohar Naik to explain to him the seriousness of the matter
and our action. The company, as we had predicted, approached the minister.
However, he was not moved, he recalls.
“I cannot explain the kind of pressure I had to deal with, but I was adamant and
firm on my decision. I must have received at least 10 [phone] calls every day
asking me to rescind the notice. I explained to everyone the seriousness of the
issue and a company like Johnson and Johnson can not play with the lives of its
customers,” he says.
J&J finally moved the court and started legal proceedings.
In September 2013 the court agreed that a carcinogenic substance was used but
since the plant was already shut for 90 days and production had stopped, the
FDA was asked to issue a fresh notice.
“I was directed to change my affidavit and in the meantime the plant could
restart. Since it was a court order, my hands were tied. In August 2014 I was
transferred. There was a lot of pressure to transfer me from various quarters,
including industry bodies. However, the best thing was the news about J&J had
spread globally and the USFDA and other concerned authorities contacted me to
understand the gravity of the situation,” says Zagade.
“During my tenure I wanted the Maharashtra FDA to emerge as a department
that cares for the people, guards them from unscrupulous elements. Public good
must prevail over private interests,” he says.
During his tenure as the chief of FDA, Zagade was also instrumental in banning
gutka and pan masala in Maharashtra. Also he took action against errant
chemists operating without pharmacists, or selling medicines without prescriptions; he played a major role in cracking down on internet pharmacy rackets, and exposed the illegal trade of addictive prescription drugs. His insistence on following the rule book was termed “administrative terrorism” by his colleagues.