Following the Gujarat Food & Drugs Control Administration (FDA)’s decision during September this year to ban GlaxoSmithKline's popular paracetamol 500 mg tablet 'Crocin Quik' for not conforming to Indian Pharmacopoeia, the Maharashtra FDA has banned the drug in the state for same reasons.
Stocks worth Rs. 2-3 lakh have been seized and the company has withdrawn the product from the state market, said the FDA officials. The company officials were not available for comments.
Speaking to Pharmabiz, a senior Maharashtra FDA official said,” The product was found to be film coated. As per the Indian Pharmacopoeia, paracetamol tablets are not allowed to be either film coated or have additional colouring agents. The order to ban the product was issued last week and the product has been withdrawn from the market”.
He said GSK was marketing the drug as a proprietary & patented medicine. However, the state FDA feels the product should be classified as a new drug and requires approval from the Drug Controller General of India (DCGI), he explained.
As Pharmabiz reported earlier, Gujarat FDA found the product contain Titanium Dioxide as colouring agent, and was film coated. As per the Indian Pharmacopoeia, paracetamol tablets are not allowed to be either film coated or add colouring agents. Further, the product is claimed to dissolve quickly, though an average 30 minutes is the normal time for dissolution of paracetamol IP tablets. The label claims of the product also indicate it is having 'Advanced Formula' and 'Fast Acting'.
The Gujarat FDA commissioner Dr S P Adeshera also had written to the DCGI to ban the product nationally, besides informing the Karnataka state drug controller. While GSK is marketing the drug as a proprietary & patented medicine licensed from Karnataka, the FDA is of the opinion that the product should be classified as a new drug and requires the approval from the Drug Controller General of India (DCGI). The drug is marketed in India by GSK Asia and is manufactured by Remidex Pharmaceuticals Pvt. Ltd., Bangalore.
Crocin 500 is the flagship OTC brand of the GSK Consumer Healthcare and has two more variants, Crocin Pain Relief and Crocin Quick. GSK Consumer Healthcare launched Crocin Quik during this year in India and the product is claimed to be superior because of its sodium bicarbonate combination. Crocin Quik, the company claims, acts faster and helps provide faster relief from fever and pain, with no side-effects. The dosage recommended is one to two tablets, thrice or four times a day. It comes in a blister pack of 10 tablets and is priced at Rs 12.75 a pack.