Drug regulator orders recall of Novartis’s painkiller diclofenac - (livemint.com via NewsPoints Desk)

  • The Drug Controller General of India (DCGI) has ordered a recall of Novartis' analgesic diclofenac in response to safety concerns raised by a health ministry panel, livemint.com reported.

  • Earlier this month, the DGCI ordered state authorities to terminate the license of the drug, which is also manufactured domestically by Themis Medicare.

  • Troikaa Pharmaceuticals had alleged that the drug, which Novartis sells under the name Voveran and Themis markets as Aquadol, contains Transcutol-P, which has been linked to kidney damage.

  • Troikaa had also claimed that Themis included Transcutol-P in its formulation to avoid infringing its patents for Dynapar AQ.

  • A government official disclosed that the decision was made after a committee failed to find any evidence supporting Novartis and Themis' claims and suggested that Transcutol-P should be independently tested for toxicity.

  • "We would like to clarify that we at Novartis have not received any communication from the regulatory authorities asking us to recall diclofenac 1ml injections from the market," the company said, adding "Novartis would respond to any concerns that the regulatory authorities may have about diclofenac 1ml, should it receive any communication from them in this regard."

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