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Drug regulator cancels licence for Diclofenac sold by Novartis

Press Trust of India  |  New Delhi 

India's drug regulator has enforced a ban on the manufacture and sale of painkiller injection, Diclofenac, marketed by Ltd, after a Ministry panel raised concerns over the medicine's impact on

"The DGCI ordered for the cancellation of the granted to for sodium injection 75 mg/ml, containing Transcutol-P ...on July 4," a government said.

The drug general of (DCGI) further ordered for the withdrawal of the drug's from the market.

The order came as a shot in the arm for Troikaa Pharmaceuticals Ltd, based in Gujarat, which had claimed that the sodium 75mg/ml injection contained Transcutol-P which caused damage to the kidneys.

injection was marketed by under the brand name Voveran 1ml.

Following allegations by Troikaa, which had approached the 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 moved the which gave a clean chit to the company prompting Troikaa to approach the in 2016.

"A third committee was then formed under Girish Sahni, director general, (CSIR), in May last year which in its report, submitted in December, backed the claims made by Troikaa," the said.

The DCGI has directed the in Dehradun, Uttarakhand, and the drug licensing authority of to cancel the license granted to M/s to manufacture for sale of Diclofenac injection 75 mg/ml containing Transcutol-P, the said.

(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, July 12 2018. 20:10 IST
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