DoP Asks NPPA To Refix Ceiling Price Of Abbott’s Phenytoin

The Department of Pharmaceuticals (DoP) asks National Pharmaceutical Pricing Authority (NPPA) to refix the ceiling price of Phenytoin-30mg/5ml for which the Abbott Healthcare had before documented a review petition with the DoP.

The company, in its review petition, asserted that the draft working sheet for ceiling price calculation of Phenytoin-30mg/5ml was bearing an anomaly.

“The regulator has thought about the price to the retailer (PTR) as Rs.54.48 per bottle of Eptoin 30mg Suspension 200ml while the correct PTR is Rs.59.81 and PTR per ml is Rs.0.30,” it said in its submission.

The company additionally submitted that since the review petition of ceiling price of Phenytoin 100mg tablets was pending with the NPPA, the percentage considered for reduction under the monopoly of Phenytoin was incorrect.

Countering the arguments of the drug manufacturer, the regulator said the points raised by the company were not relevant as the PTR was considered according to information provided by PharmaTrac and the price fixation has been done strictly as per the provisions of DPCO, 2013.

During the proceedings, the company has submitted a representation against the draft working sheet. However, the regulator has rejected it saying the representation isn’t convincingly demonstrated.

The representatives of the company also submitted documentary proof in support of correct PTR of Phenytoin 30mg/5ml oral liquid, which is Rs.59.81, though, in the calculation sheet, it is shown as Rs.54.48.

Accepting the review petition, the DoP has directed the drug price regulator to examine the ceiling price of Phenytoin 100mg tablet in the calculation sheet for percentage reduction under monopoly condition.

The regulator was also requested to hear the petitioner, examine the relevant documents furnished by them in support of their claim about correct PTR of Eptoin 30mg Suspension 200ml and refix the ceiling price of Phenytoin-30mg/5ml.

The records to be examined include copies of sample invoices to the retailer. The NPPA should implement the directions within a period of thirty days and submit a compliance report. The phenytoin-30mg/5ml suspension is an antiepileptic medicine.

It controls seizures or fits by decreasing the abnormal and excessive activity of the nerve cells in the brain.

Abbott India is an Indian subsidiary of the American healthcare company Abbott Laboratories. It has a strong brand presence in several therapeutic categories ranging from women’s health to gastroenterology, neurology, thyroid, diabetes, urology, pain management, vitamins, and anti-infectives.

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