Despite the ban of GSK's Crocin Quik by two major drug consuming states Maharashtra and Gujarat, the controversial paracetamol preparation is freely sold all over in Karnataka as the Drugs Control Department is unsure of stopping its sale. It is the Karanataka DC which had issued the manufacturing licence to one of GSK's associates to produce the formulation in the state.
The Gujarat FDA commissioner Dr S P Adeshera had intimated the Karnataka DC, MN Ramamurthy that Crocin Quik, manufactured by Remidex Pharma at its facility located at the Peenya Industrial Area in Bangalore under the category of 'proprietary and patented' medicine needed a mandatory clearance from the DCGI as per the provisions of Rule 122B, 122D and 122A of the Drugs and Cosmetics Act.
But the Karnataka drugs controller is hesitating to take any action immediately and decided to look into the issue next week, according to sources.
Officials from Remidex Pharma, a leading contract manufacturing firm in Karnataka producing the drug and a range of other products for GSK refused to comment. At the same time GlaxoSmithKline Asia Pacific in a statement said, "Crocin Quik is a good formulation that acts twice as fast as regular paracetamol tablets and has no health and safety issues . In fact, the formulation has been clinically researched and proven for its safety and efficacy and is currently available in over 70 countries across the world as an over the counter (OTC) medicine".
GSK AP statement further said, "The issue really is about a difference in regulatory interpretation by the FDA Commissioner, Maharashtra over the clearance given by the DCGI. The company is in discussion with both the DCGI and the Maharashtra FDA Commissioner to understand and resolve the matter at the earliest, in the interest of the consumers".
The company has complied with the mandated procedure for the approval of manufacture and marketing of Crocin Quik as a coated paracetamol tablet containing titanium dioxide in India.
When asked whether, in the wake of the ban orders issued by the Gujarat and Maharashtra FDA, would GSK AP continue to manufacture the product, the company said that it would not be appropriate to speculate on this.