Novartis’s diclofinac injection flagged by health ministry panel
New Delhi: A health ministry panel has raised concerns about the safety of painkiller injection diclofenac marketed by drug maker Novartis India and made by Themis Medicare Ltd, after Troikaa Pharmaceuticals alleged that the painkiller injection contains Transcutol, which damages kidneys.
A panel was formed under Girish Sahni, director general, Centre of Scientific and industrial Research (CSIR), in May after two other expert panels formed to review the safety of Transcutol-P came out with contradictory reports on Troikaa’s allegations.
The Sahni panel, which submitted its report on 29 December, endorsed Troikaa’s submissions. The committee also did not find any evidence supporting the claim of Novartis and Themis, two people aware of the matter said, adding that the panel has recommended that Transcutol-P be independently tested for toxicity.
While Troikaa declined to comment, a spokesperson for Themis said: “Post our meeting with the committee sometime in July 2017, we do not have any further status on the subject from authorities, hence unable to comment.” The Themis spokesperson maintained that product is absolutely safe.