Drug Regulator Cancels Novicis Pain Relief License, Diclofenac, for Safety Reasons

DGCI authorized Themis Medicare Ltd to manufacture painkillers raised on Using the ingredient, Troikaa, a rival pharmaceutical company, had claimed that several countries were banning the use of Transcutol-P in "parenteral preparations." Troikaa challenged the drug regulator by saying that the painkiller Diclofenac So Dium 75mg / ml is not used in injections elsewhere in the world.

DGCI on July 4 led the drug controller of Dehradun, Uttarakhand and Daman and Diu to cancel the license of Themis Medicare for the manufacture of the harmful drug. It was a moment of victory for Troikaa, who has struggled for two years since arriving at the Delhi High Court in 2016.

The drug, marketed under the brand Voveran 1ml and Aquadol, competed with the injection of Troikaa Dynapar AQ. A third panel was formed under the direction of Girish Sahni, Director General of the Council for Scientific and Industrial Research (CSIR) in May, after the two previous panels had issued conflicting reports on the safety of the drug

"Transcutol -P The parenteral formulation must be tested independently to determine its toxicity in order to establish its safety No evidence has been presented to the committee that it can be used in parenteral formulations, including the Indian pharmacopoeia , especially for parenteral preparation for human use, "said Sahni Committee

Reuters

The Drug At least three species of vultures in Southeast Asia have decreased by more than 99 percent since the 90s because of the widespread use diclofenac in veterinary medicine. at table elevation in the vulture population. In addition, the Secretariat of the Convention on Migratory Species and BirdLife International have called for the ban of diclofenac in European countries.