India’s drug regulator has ordered the withdrawal of the popular diclofenac painkiller injection marketed by Novartis India Ltd and made by Themis Medicare Ltd, following safety concerns raised by a a health ministry panel.
The drug controller general of India (DCGI) on 4 July directed the state drug controller in Dehradun, Uttarakhand, and the drug licensing authority of Daman and Diu to cancel the manufacturing licence granted to Themis Medicare for diclofenac sodium injection 75 mg/ml using Transcutol-P.
The order comes as a victory for Gujarat-based Troikaa Pharmaceuticals Ltd, a rival pain management injection manufacturer, which had waged a two-year battle. Troikaa had alleged that diclofenac sodium 75mg/ml injection contains Transcutol-P, which causes kidney damage. Diclofenac injection is marketed by Novartis under the brand name Voveran 1ml, and Themis’s brand Aquadol had competed with Troikaa’s injection to manage pain, Dynapar AQ.
- In 2015, Troikaa approached DCGI and the health ministry to stop sales and cancel the licence of the painkiller injection manufactured by Themis and marketed by Novartis. The government then set up an expert committee, which submitted a report favouring Troikaa.
- However, Novartis moved the health ministry, after which a second committee was formed under the then Directorate General of Health Services (DGHS). This committee gave a clean chit to Novartis, prompting Troikaa to approach the Delhi high court in 2016.
- The efficacy and safety of the additive Transcutol-P came under the scanner after Troikaa claimed that it was not used anywhere in the world, and was not permitted for use in parenteral preparations, meaning that it cannot be used in intravenous or intramuscular injections. It also alleged that Themis Medicare manufactured a version of Diclofenac Inj 75mg in 1ml with Transcutol-P to avoid infringing Troikaa’s patent.
- Diclofenac 1ml is being marketed in India for over three years based on approvals granted to the manufacturer Themis Medicare Ltd.