The cancellation issued by the Punjab government followed reports that five women in Kota, Rajasthan, died after allegedly being administered an Oxytocin injection that upon testing found contained no active ingredient.
In a rejoinder filed on Tuesday to the Punjab health authorities, the company has pushed back sharply against the state’s assistant commissioner (drugs), the licensing authority that issued the cancellation order, disputing both the test findings and the process used to arrive at them.
The company has also refuted the charges that young women tragically died in Kota allegedly due to a spurious oxytocin injection, commonly used to induce labour pain and treat or prevent post-partum haemorrhage in pregnant women.
The vials allegedly had nothing but water and no active ingredient.
The drug regulatory authorities had cancelled Jackson Laboratories’ licence in June after this incident came to light. However, the company stated that the Kota hospital involved has clarified that the adverse reactions have “not occasioned due to the use of” its Oxytocin injection. It further argued that it “goes beyond imagination” that action is being taken against the company over the Kota deaths, while noting that other fatalities in Rajasthan were reported in Bikaner, Jodhpur, Nagaur, Bhilwara and Banswara locations where, it said, its product “was never used”.
“The inspection based upon risk reported by the hospital at Kota, Rajasthan regarding Oxytocin injection, and consequent action taken by the respondent based thereupon, is again completely misplaced and misfounded,” said the rejoinder filed by their advocate Sanjay Kumar Jain. The company will present its case before the state health secretary.
“While the case was supposed to be heard on Thursday it was adjourned and the next date is yet to be given,” said a person in the know.