The Indian who made J&J stop baby(Times of India)

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.

Cracking down

“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

multinational company.

“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.

Order, order

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.

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