GSK says its Calpol suspension outside DPCO, state FDA disputes

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In order to counter Maharashtra Food and Drug Administration (FDA) action of stop sale order for paracetamol brand Calpol 60 ml syrup on account of overpricing, GlaxoSmithKline claims that therapeutic dose of Calpol suspension of 120 mg/ 5ml which they are manufacturing for the past 30 years does not fall under the Drug Price Control Order (DPCO) -2013. FDA officials ,however maintain that paracetamol brand Calpol suspension sold in 60 ml bottle is subject to National Pharmaceutical Pricing Authority (NPPA) scrutiny as it has been manufactured since 2007 after tweaking the standard therapeutic dosage of 125 mg/5 ml mandated by the NPPA to 120 mg/5ml and selling at an overpriced rate.

GlaxoSmithKline has claimed that Calpol suspension of 120 mg/5ml which is available in the market for more than 30 years is not part of National List of Essential Medicines (NLEM) and hence is outside the purview of DPCO schedule 2013.

Maharashtra FDA is also planning to approach the NPPA for recovery of the excess amount earned as profit by the company on its paracetamol brand Calpol oral suspension sold in 60 ml bottle in contravention to DPCO rules.

Mumbai based NGO Society for Awareness of Civil Rights has also petitioned to the Drug Controller General of India (DCGI), NPPA and Maharashtra FDA requesting order for verification and recall of all sub – therapeutic dose of paracetamol syrup or suspension (120 mg/5ml) manufactured by GSK from the market intentionally done to evade DPCO.

However, a GSK spokesperson while contradicting the pricing regime maintains, “The underlying principle of the National Pharmaceutical Policy and DPCO 2013 is to include those medicines that are under National List of Essential Medicines (NLEM) having specific strengths and dosage.”

Argues president of Mumbai based NGO Society for Awareness of Civil Rights R P Yajurvedi Rao,” GSK is playing with the therapeutic dosage of the paracetamol brands to come out of the DPCO purview and rake in huge profits. The NGO in a letter addressed to the FDA also requested to seize and recall all Crocin Advance stocks having Rs. 30 as MRP for 15 tabs in the past.

“We therefore demand that the actions to revoke drug license, recall all the overcharged drugs in paracetamol whatever the claim and order to deposit the proceeds of the excess amount collected in to the public exchequer,” Rao added.

Meanwhile, NPPA has also denied a price control exemption to GSK Consumer Division for the drug Crocin Advance. Now, Crocin Advance is priced at 94 paise per tablet, which is the ceiling price under DPCO 2013.

GSK Consumer Division, in September 2013, had launched a 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. Based on their claim of new drug, GSK Consumer had sought an exemption for 5 years from the pricing regulator. Crocin Advance currently sells at Rs. 2 per tablet, at least 120 per cent higher than the set ceiling price for all paracetamol 500mg tablets. NPPA has ruled that a different manufacturing technology or faster action mode does not qualify for a new drug status.

State FDA had recently issued stop sale order of Calpol 60 ml syrup manufactured by GSK under the brand name of Calpol till further notice stating that the prices charged for this product violate the Drug Price Control Order (DPCO). A combination of the narcotic hydrocodone and non-narcotic pain reliever acetaminophen, paracetamol oral suspension IC is prescribed for moderate to severe pain and fever. FDA had earlier taken action against GSK for overpricing of paracetamol brands like Crocin Advance, Crocin suspension and Crocin drops and seized products to the tune of Rs. 12 lakh.

Stop sale order for Calpol 60 ml syrup was issued after FDA seized 6, 500 bottles of paracetamol oral suspension IC, sold under the brand name Calpol worth Rs. 2.11 lakh from the GSK’s Bhiwandi Godown, stating that the prices charged for this product violate the Drug Price Control Order (DPCO). As per the new DPCO, Calpol 60 ml should cost Rs. 20. 79 but has been priced at Rs. 32.75 per bottle. The manufacturer has been asked to call back the bottles from the market.

As per the new DPCO, one 500 mg paracetamol tablet should cost 0.94 paise but Crocin Advance is priced at Rs. 2 per tablet. Besides GSK’s two other products are also over priced. In liquid form, the price of a bottle of 60ml paracetamol is fixed at Rs. 19.20 but Crocin suspension is priced at Rs.  37.77. Also, 15 ml should cost Rs. 4.80 but a bottle of Crocin drops is priced at Rs. 29.

Source: PharmaBiz

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