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MAKING A ‘QUIK’ BUCK
P A Francis | Wednesday, December 21, 2005, 08:00 Hrs  [IST]

When pharma companies attempt to irresponsibly exploit one of their established brands on the hope of making a quick buck they flounder somewhere. This is what has happened to GSK in the case of ‘Crocin quik’. GSK Consumer Healthcare launched Crocin quik early this year claiming it as a superior product acting fast and providing faster relief from fever and pain with no side effects on the label. This brand extension of Crocin is a combination containing 500 mg of paracetamol with sodium bicarbonate. GSK already has another brand extension of Crocin namely Crocin Pain Relief in the Indian market. Exploitation of a well known brand is a routine strategy advised by marketing wizards of pharma companies usually without looking at regulatory procedures and safety concerns. India being a huge market with a decentralized licensing system pharma companies are able to get away with unethical marketing of some products with unsubstantiated claims for some time. Unfortunately for the companies, some alert drug officials happen to stumble upon such product. In the case of Crocin quik, Gujarat FDA is the first state drug authority to detect the product containing besides 500 mg paracetamol, sodium bicarbonate and titanium dioxide. The product was also found to be film coated. As per standards laid down in Indian Pharmacopiea, paracetamol tablets are neither allowed to be film coated nor it should have colouring agents. As the product is a fixed dose combination, the company should have obtained a marketing permission from DCGI. This is not done. Gujarat FDA commissioner promptly banned sale of the product in the state and wrote to DCGI recommending a national ban of the product. Gujarat Commissioner sent a letter to state drug authority in Karnataka in this regard as it had issued the manufacturing licence and advised a similar action in Karnataka. Both DCGI and Karnataka state drug control authority are yet to respond to Gujarat commissioner’s alert. However, last week, Maharashtra FDA ordered the ban of Crocin quik in the state for the same reasons pointed out by the Gujarat commissioner. GSK management should know that any FDC is classified as a new drug and it has to approach DCGI for its marketing approval. And marketing permission is granted after satisfactory completion of statutory clinical trials in the country. It is possible that some of the state drug authorities in the country could issue a manufacturing licence for a combination product by default as there is still no proper coordination between various state drug authorities and the DCGI. Pharma companies should not exploit a situation like this. What is however important is that DCGI should take a stand on this issue immediately by either banning the product nationally or explain action taken by the two state governments. A partial ban of the product, as it stands now, is untenable and will make a mockery of the drug rules in the country.

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