India's drug regulator has enforced a ban on the manufacture and sale of painkiller injection, Diclofenac, marketed by Novartis India Ltd, after a Health Ministry panel raised concerns over the medicine's impact on health.
"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 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.
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 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.
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)