The Drug Controller General of India (DCGI) further ordered for the withdrawal of the drug’s stock from the market.
New Delhi: India’s drug
regulator has enforced a ban on the manufacture and sale of painkiller
injection, Diclofenac, made by Themis Medicare and marketed by Novartis
India Ltd under the brand name Inj Voveran 1ml, after a Health Ministry
panel raised concerns over the medicine’s impact on health.
Medical dialogues had earlier reported
that a panel from health ministry had raised concerns over the safety of
diclofenac injection. The panel was responding to the allegations
raised a by Gujarat based Pharma Company on the safety of the Novartis
Drug
Read also: Voveron 1ml causes Kidney Damage: Health Ministry panel recommends toxicity check for component
“The DGCI ordered for the cancellation
of the manufacturing licence granted to Themis Medicare for Diclofenac
sodium injection 75 mg/ml, containing Transcutol-P …on July 4,” a
government official said.
The Drug Controller general of India (DCGI) further ordered for the withdrawal of the drug’s stock from the market.
The
order came as a shot in the arm for Troikaa Pharmaceuticals Ltd, based
in Gujarat, which had claimed that the diclofenac sodium 75mg/ml
injection contained Transcutol-P which caused damage to the kidneys. .
As per pharmaceutical market research firm AIOCD Pharma Trac, Troikaa
and Novartis together command over 60% market share of 1 ml diclofenac,
which is estimated to be worth around Rs 2000 crore.
Diclofenac injection was marketed by Novartis under the brand name Voveran 1ml.
It is reported that following
allegations by Troikaa, which had approached the Health Ministry to stop
the injection’s sales, the government had formed a panel to review its
safety in 2015. The panel submitted a report favouring Troikaa.
A second committee was formed after
Novartis moved the Health Ministry which gave a clean chit to the
company prompting Troikaa to approach the Delhi High Court in 2016.
“A third committee was then formed under
Girish Sahni, director general, Council of Scientific and Industrial
Research (CSIR), in May last year which in its report, submitted in
December, backed the claims made by Troikaa,” the official said.
The DCGI has directed the state drug
controller in Dehradun, Uttarakhand, and the drug licensing authority of
Daman and Diu to cancel the license granted to M/s Themis Medicare to
manufacture for sale of Diclofenac injection 75 mg/ml containing
Transcutol-P, the official said.
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