Delhi HC seeks Centre, Novartis response on Troikaa Pharma petition for ban on painkiller injection Diclofenac

By: | Updated: May 21, 2016 8:40 AM

The Delhi High Court on Friday sought response from the Centre, Novartis India and others on a petition by Gujarat-based Troikaa Pharmaceuticals Ltd asking the Drug Controller General of India (DCGI) to stop sales and cancel licence of popular painkiller injection Diclofenac over safety concerns.

Dishman PharmaVoveran 1ml and Aquadol are in competition with Troikaa’s own painkiller injection Dynapar AQ since their launch in 2013. (Photo: PTI)

The Delhi High Court on Friday sought response from the Centre, Novartis India and others on a petition by Gujarat-based Troikaa Pharmaceuticals Ltd asking the Drug Controller General of India (DCGI) to stop sales and cancel licence of popular painkiller injection Diclofenac over safety concerns.

Troikaa has challenged the DCGI’s May 5 order which allegedly allowed Mumbai-based Themis Medicare Ltd to manufacture painkiller drug Diclofenac Sodium 75mg/ml injection containing the expedient Transcutol, which “is not permissible in law for use in parenteral preparations.”

The DCGI by way of May order had reversed its earlier order of April last year that found the drug unsafe, it said, adding that the ingredient may compromise patient safety because it is not used in injections anywhere else in the world.

Troikaa said that a different version of Diclofenac Sodium 75 mg/ml manufactured by Themis and being marketed by Novartis India Ltd under the brand name Voveran 1ml and Themis’ Aquadol, which contain ‘Transcutol P — a solvent and solubiliser — supplied by French firm Gattefosse, are unsafe for use in injectable solutions.

Voveran 1ml and Aquadol are in competition with Troikaa’s own painkiller injection Dynapar AQ since their launch in 2013. However, Troikaa says that Themis and Novartis have changed formulation of its original composition so as to be able to manufacture and market a subsequently approved version thereof without infringing its patent.

The Indian pharma company further alleged that Novartis itself does not use Transcutol in injection marketed by it elsewhere in the world and appears to have selected only India to introduce an unsafe drug.

It said that the DCGI revocation of its earlier order was “arbitrary, illegal and perseveres” and even assuming that there was a need for a second expert panel to look into the issue, the drug could not have been allowed to be manufactured during the pendency of the matter, thus causing potential health hazard in the country, which is impermissible under the circumstances. “…the use of transcutol in injections was rejected by one subject expert committee (antimicrobials)” and the committee of CDSCO experts had also found the data submitted by Themis as inadequate to establish its safety, according to petition.

It further said that while it is imperative for the authorities to cancel the licence of the unsafe product, the DCGI on the contrary is forming committees one after another to declare the use of transcutol as safe.

Justice Manmohan issued notice to the ministries of health and family welfare and chemicals and fertilisers, Drugs Cotroller General, Drugs Controlling and Licensing Authority, Novartis India, Themis Medicare and others. The matter will be further heard on May 26.

Troikaa further pointed out that in order to avoid stringent, time consuming and high cost requirements of permission of manufacture a “new drug” from the drug authorities, Themis directly obtained the license from the Drug Licensing Authority, Daman and Diu and the Drug Controlling and Licensing Authority, Uttarakhand.

The petition also notes that in another injection called, “Alpha beta Arteether 75mg/ml IV/IM Injection”, sought to be manufactured by Themis had been rejected approval by the Centre on account of the fact that Transcutol was one of the excipients used, which was not considered safe.

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