The National Pharmaceutical Pricing Authority (NPPA) has decided not to change the ceiling price of Sun Pharmaceuticals’ nitrofurantoin 100mg capsule which is set currently at Rs.7.13 but marginally raised the price of Abbott Healthcare’s phenytoin-30mg/5ml from Rs.0.28 per ml to Rs.0.29 excluding GST. Both the companies had earlier obtained favourable orders from the Department of Pharmaceuticals (DoP) regarding the maximum retail prices of these products.
The drug pricing authority took these decisions at a meeting held on April 23.
Nitrofurantoin is an antibacterial agent used commonly in the treatment of acute or recurrent, uncomplicated lower urinary tract infections or inflammation of the renal pelvis, either spontaneous or following surgical procedures. Phenytoin-30mg/5ml suspension is an antiepileptic medication that controls seizures or fits by decreasing the abnormal and excessive activity of the nerve cells in the brain.
The DoP had earlier found merit in Sun Pharma’s contention that Urifast CP 100 mg capsule of Cipla was not included in ceiling price calculation despite the product having nitrofurantoin 100mg as composition. But according to the minutes of the NPPA meeting, reviewed by Pharmabiz, the authority observed that the drug maker had failed to submit the original sample of Urifast CP 100mg capsule manufactured in or before August 2015. The base price considered for fixing the ceiling price is of August 2015.
In the case of phenytoin-30mg/5ml, Abbott Healthcare had contended that the draft working sheet for ceiling price calculation of phenytoin-30mg/5ml was bearing an anomaly. “The regulator considered price to retailer (PTR) as Rs.54.48 per bottle of Eptoin 30mg suspension 200ml whereas the correct PTR was Rs.59.81 and PTR per ml was Rs.0.30,” it had said it its submission. The drug maker further submitted that since the review petition of CP of phenytoin 100mg tablets was pending with the NPPA, the percentage considered for reduction under monopoly of phenytoin was incorrect.
While revising the ceiling price, the authority noted that due to revision in the price of phenytoin 100mg tablet, its percentage reduction changed from 16.30 to 5.19 and as a consequence, average percentage reduction for all strengths changed from 9.38 to 7.53.
The regulator, which was directed by the DoP to refix the prices of Cadilla Healthcare’s omeprazole 20mg tablets and Sun Pharma’s sodium valproate 200mg tablets, has referred these cases back to the multi-disciplinary panel of experts for reconsideration after co-opting a clinical pharmacologist and therapeutical expert. A list of experts available with the Central Dugs Standard Control Organisation (CDSCO) will help the multi-disciplinary panel to revise the prices of these medicines. Omeprazole is used to treat certain stomach and esophagus problems such as acid reflux and ulcers. Valproic acid, its salts and esters are used in the treatment of various types of epilepsy.