Monday, April 7, 2014

GSK starts nationwide recall of Crocin Advance following state FDA's stop sale order

GlaxoSmithKline Asia Pvt Ltd (GSK) has launched a nationwide recall of its paracetamol brand, Crocin Advance, from the retailers and wholesalers following Maharashtra FDA's stop sale order issued to the company for overcharging the drug. recently. Most of the retailers across the country have also stopped stock and sale of the drug.

Now, Crocin Advance will have to be sold at Rs.14. 84 for 15 tablets, which is the ceiling price fixed for a strip of  paracetamol tablets of 500 mg under DPCO 2013. The price is already effective nationwide. Informs a GSK spokesperson to Pharmabiz, "GSK is reducing price of Crocin Advance Paracetamol Fast Release 500 mg as per the provisions of the Drugs Price Control Order (DPCO), 2013 with immediate effect. GSK has been and will continue to be compliant with the law of the land.”

An FDA official maintains that recall of Crocin Advance by GSK got initiated on March 26, 2014 based on NPPA's response and selling of the drug at the DPCO price will most probably be applicable once the manufacturer supplies the drug to the market again after relabeling, which might take a couple of months. 

"Action can be taken against the retailer for selling and stocking the drug at the overpriced rate, the official explains, in violation of DPCO rules. Penalty may range from suspension of license to prosecution, " explains an official.  

Says Hakim Kapasi, president, Andheri Chemists Association, "We have stopped stocking and selling Crocin Advance based on FDA orders till further notice. Stop sale of Crocin Advance will not affect the supply of medicine which was a widely used Analgesic till a week back as there are other paracetamol brands available in the market from Ranbaxy, Cipla, Veritas and Blue Cross." 

GlaxoSmithKline consumer division, in September 2013, had launched the new brand Crocin Advance and discontinued all older Crocin brands. GSK consumer claims this is an innovation drug, with an advanced technology that allows paracetamol to dissolve faster in the blood stream versus any other available brands of paracetamol 500 mg. 

Clarifying the company's stand on the issue a GSK Spokesperson explains, "Crocin Advance has a superior pharmacokinetic profile to standard paracetamol tablets and has been approved as New Drug Formulation by CDSCO. GSK had applied to NPPA through Remedix Pharmaceuticals, the manufacturer of the drug, for grant of exemption  from price control under the provisions of Para 32, in DPCO 2013." 

Based on their claim of new drug, GSK Consumer had sought an exemption for 5 years from the pricing regulator.  The company says that Para 32 of DPCO 2013 provides exemption to a manufacturer producing a new drug involving a new delivery system developed through indigenous research and development (R&D)for a period of five years from the date of its market approval.

Having denied the price control exemption to Crocin Advance, NPPA is also planning to initiate action against the company for overcharging consumers and recover the overcharged amount. 

However, the NPPA has now ruled that a different manufacturing technology or faster action mode does not qualify for a new drug status. The decision was based on the report by the technical committee set up by NPPA to review this matter.

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