DCGI canceled the license for Diclofenac injection marketed by Novartis

Medicare News

With the raised concern by the Indian health ministry panel the license of Diclofenac injection sold by Novartis has been canceled by DCGI. The brand name of the Diclofenac painkiller injection is Voveran 1ml and it is marketed by Novartis. Finally, Gujarat-based Troikaa Pharmaceuticals Ltd won from his rival pain management injection producer and battled two years long for this to happen.

Aquado and Dynapar AQ had great competition from Themis’s and Troikaa’s respectively. Troikaa had alleged that Diclofenac sodium 75mg/ml injection contains Transcutol-P, which causes kidney damage. After Troikaa allegation, DCGI scanning the use of Transcutol-P and also said that its use was not permitted anywhere in the world especially for use in parenteral preparations. It means that it cannot be used in intravenous or intramuscular injections. Troikaa wanted health ministry to take stop sales and cancel the license of the painkiller injection manufactured by Themis and marketed by Novartis.

The government then set up an expert committee, which submitted a report favoring Troikaa. Then Novaris approached health ministry health ministry, then a second committee was formed under the Directorate General of Health Services (DGHS) gave a clean chit to Novartis. Then Finally Troikaa approached the Delhi high court in 2016.

India has around 2000 crores worth of the pain management market and the Voveran 1ml injection market cost is worth 260crores. According to AIOCD Pharma Trac, market research firm over 60% of India’s pain management market command by Troikaa and Novartis together.

The State drug controller in Dehradun, Uttarakhand, and the drug licensing authority of Daman and Diu directed by the DCGI to cancel the manufacturing license granted to Themis Medicare for diclofenac sodium injection 75 mg/ml using Transcutol-P.

As per the government reports the decision was made after getting the reports from the third committee that was formed after Union health minister J.P. Nadda intervened in the matter. The panel recommended testing Transcutol-P independently for toxicity.

No evidence has been presented before the committee that it can be used in parenteral formulations, even including Indian pharmacopeia, especially on parenteral preparation for human use.

The committee formed a report and shared with the Delhi high court. While Troikaa declined to comment, Novartis said the company is yet to receive a recall letter from the drug controller.


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