GSK Pharmaceuticals has recently launched a paracetamol product in the market namely, Crocin Advance, claiming it as a new product and discontinued its several decades old brand, Crocin. Both the newly launched product and the discontinued Crocin are for pain relief only and the active ingredient in both the products are paracetamol 500 mg.
While the Crocin Advance is priced at Rs.30 for a strip of 15, the old Crocin was priced at Rs.12.70 for a strip of 15 tablets. Both the products contain paracetamol mg and the strips of Crocin Advance look identical to the strip of Crocin.
The company has launched a promotional campaign for popularizing Crocin Advance in one of the FM radio channels for some time now. The ad in the radio channel claims that the drug start releasing to blood stream in five minutes of consuming it.
Informed sources point out that GSK stands to gain substantially in terms revenue as the newly launched Crocin Advance has almost a 150 per cent increase in MRP over the old Crocin.
According to experts, the GSK's strategy in launching Crocin Advance is nothing but a well calculated ploy to hoodwink the drug control authorities to come out of the price control regime as paracetamol 500 mg falls under the new DPCO-2013 and the ceiling price of paracetamol 500 mg in the new DPCO-13 is just a fraction of the Crocin Advance's MRP of Rs.30 for a strip of 15 tablets.
They point out that the company has exploited a loophole in the law and has got a 'new drug' tag for its Crocin Advance from drug authorities. As per the DPCO-13 (section 32) “Non – application of the provisions of this order in certain cases.- The provisions of this order shall not apply to, - a manufacturer producing a new drug involving a new delivery system developed through indigenous Research and Development for a period of five years from the date of its market approval in India: Provided that the provision of this paragraph shall apply only when a document showing approval of such new drugs from Drugs Controller General (India) is produced before the Government. Explanation.- Notwithstanding anything contained in this Order, for the purpose of this paragraph “new drug” shall have the same meaning as is assigned to under rule 122E of the Drugs and Cosmetics Rules, 1945.”
Meanwhile, the drug authorities in Kerala are not allowing to sell the product in the state, stating that the drug falls under price control. Drug authorities in Kerala contest that since both Crocin and Crocin Advace were taken into consideration for calculating the ceiling price of paracetamol 500 mg by the NPPA both should fall under DPCO and the company should reduce the price to match the ceiling price which is 94 paise plus local tax per tablet.
Interestingly, when the company submitted its papers to the NPPA, the MRP for Crocin Advance was quoted at Rs.25.25 which has since been hiked to Rs.30 for a strip of 15 tablets.
An e-mail sent to the company for its response did not elicit any answers till the time of filing of this report.
Later, reacting to the story on Crocin Advance published in Pharmabiz on September 2, a GSKCH spokesperson said, "Keeping in line with GlaxoSmithKline plc’s (GSK plc.) vision to do more, feel better, live longer GlaxoSmithKline Asia Pvt. Ltd.( GSKAP), an Affiliate of GSK plc., launched an advanced variant of Crocin- Crocin Advance in June 2011 under license issued by Drugs Control General (India) on Feb 10, 2011, much before the new regulation was introduced. Crocin Advance is a revolutionary paracetamol tablet that disintegrates five times faster compared to standard paracetamol tablets. The product promises a faster onset of action for the consumer and is allowed to be sold in all states of India."