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DoP asks NPPA to refix ceiling price of Abbott’s Phenytoin-30mg/5ml

Arun Sreenivasan, New Delhi
Tuesday, February 13, 2018, 08:00 Hrs  [IST]

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

The company, in its review petition, contended that the draft working sheet for ceiling price calculation of Phenytoin-30mg/5ml was bearing an anomaly. “The regulator has considered price to retailer (PTR) as Rs.54.48 per bottle of Eptoin 30mg Suspension 200ml whereas the correct PTR is Rs.59.81 and PTR per ml is Rs.0.30,” it said in its submission.

The company 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.

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

The company, during the proceedings, has submitted a representation against the draft working sheet. However, the regulator has rejected it saying the representation is not conclusively proved. 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, whereas in the calculation sheet, it is shown as Rs.54.48.

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

The regulator was also asked to hear the petitioner, examine the relevant documents furnished by them in support of their claim about actual PTR of Eptoin 30mg Suspension 200ml and refix the ceiling price of Phenytoin-30mg/5ml. The documents to be examined include copies of sample invoices to retailer. The NPPA should implement the directions within a period of thirty days and submit a compliance report.

Phenytoin-30mg/5ml suspension is an antiepileptic medication. 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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