New Delhi: Trouble seems to be mounting for pharma giant Novartis after a panel from health ministry has 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
Diclofenac injection is a painkiller which is manufactured by Themis Medicare Ltd and marketed by Novartis India under the brand name Voveran 1ml Injection.
Livemint reports that Troikaa Pharmaceuticals had alleged that the painkiller injection diclofenac Sodium 75 mg/ml contains Transcutol, which damages kidneys and filed a petition in Delhi High Court against the granting of manufacturing licenses for the painkiller and allowing its marketing by Novartis AG.
Troikaa has developed and sells Diclofenac Sodium 75 mg/ml injection under the brand name ‘Dynapar AQ’, which is patented globally.
The petition stated that Themis to avoid patent infringement, is manufacturing a different version of its Diclofenac Sodium 75 mg/ml injection and Novartis is marketing it.
The petition further stated that Themis and Novartis have conveniently ignored the fact that Transcutol P is not recommended for parenteral use Regulatory bodies in US, Europe, and other parts of the world do not permit it’s parenteral use, as it is known to cause injury to kidneys.
During the hearing, the court had formed an expert panel to review the safety of Transcutol-P who gave their recommendations in favor of Troikaa. Novartis then approached the health ministry after which the second panel was formed under the Directorate General of Health Services. The second panel gave their decision in favor of Novartis.
Another panel was formed under Girish Sahni, director general, Centre of Scientific and Industrial Research (CSIR), in May after the 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.
A spokesperson for Themis maintained that product is absolutely safe and told Mint, “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.”