New Delhi: The health ministry has asked a panel to submit its report within 15 days into allegations by Troikaa Pharmaceuticals Ltd on the granting of manufacturing licences for painkiller injection Diclofenac, and allowing its marketing by Novartis AG.
Gujarat-based Troikaa claims the painkiller Diclofenac Sodium 75mg/ml injection contains Transcutol, which causes damage to kidneys.
The drug maker alleged that Themis Medicare Ltd manufactured a version of Diclofenac Inj 75mg in 1ml with the additive Transcutol P to avoid infringement of Troikaa’s patent.
The panel was formed under Director General (DG) Centre of Scientific and industrial Research (CSIR) Girish Sahni in May.
The ministry in a recent letter to the DG and other members of the committee has asked the panel to come out with its recommendations without delay.
“The report is critical for both the companies and will finally sort out a long dispute between them," said a government official privy to the development.
The committee was formed after two earlier government-constituted panels gave contradictory reports on the allegations.
While the first submitted a report favouring Troikaa, the other gave the opposite view, prompting Troikaa to approach the court challenging granting of manufacturing licence for the painkiller and allowing its marketing.
According to two government officials, the Drug Controller General of India (DCGI) allowed Mumbai-based Themis Medicare to manufacture painkiller drug Diclofenac Sodium 75mg/ml injection containing Transcutol. Troikaa approached the DCGI and the health ministry to stop sales and cancel the licence of the painkiller injection, over safety concerns.
It alleged that the injections were not used anywhere else in the world and were not permissible in law for use in parenteral preparations.
“The first committee gave their recommendations in favour of Troikaa, directing the state drug controller to cancel the license of the other company. Novartis then approached the health ministry after which the second committee was formed under the Directorate General of Health Services. This committee gave a clean chit to Novartis," said the official cited above.
Thereafter, the third committee was formed after the Union health minister J.P. Nadda intervened in the matter, said another government official. Even as the tussle between the companies continues, about 125 million injections of the product have been sold by ThemisNovartis.
A Novartis spokesperson said that product is absolutely safe. “Diclofenac 75 mg/ml as an injectable is being marketed in India for close to four years based on approvals granted to the manufacturer Themis Medicare Ltd."
While Troikaa declined to comment, claiming that the matter is sub judice, a spokesperson for Mumbai-based Themis Medicare said that the company has taken market share from rivals since it launched the product.