DOP directs NPPA to fix retail price of Baclofen Oral Solution based on Sun Pharma Complaint

New Delhi: Through a recent decision, NPPA has been directed by the Department of Pharmaceuticals to refix the retail price of Baclofen Oral Solution after factoring effective (5%) GST rate.

The decision came in response to a review order that was filed by drug major Sun Pharma challenging the NPPA order that fixed the price of the said formulation at Rs 1.42 per ml

The orders came following the review application filed by Sun Pharma against the government regulatory body, the National Pharmaceutical Pricing Authority (NPPA). The drug major contended that the retail price of the concerned subject formulation was notified as Rs 1.42 per millilitre. However, the working sheet for the notification was displayed much later on the official website of NPPA. The company even claimed that the working sheet was not made available prior to price notification.

Further, the firm challenged the tax rate levied on Baclofen. The official central GST rate notified for the drug is 2.5% making the effective GST rate as 5% combining equal central and state share.

The claimed MRP mentioned in their Form I application of this formulation was Rs 160 for a 100ml pack. In the working sheet, GST of 12% was factored into the calculation of erroneously to arrived claimed retail price of Rs 1.42 per ml which otherwise would have been different had official 5% GST would have been considered. The applicant stated that in the notification on the website of CBEC, the list of goods at 5% GST rate is given, wherein Baclofen is mentioned at S.No.5 in list 1 of Schedule I describing goods charged at 5% GST rate, the company challenged

"The applicant, therefore, requested to revise the retail price of Baclofen Oral Solution by considering 5% GST.”

Responding to the allegation NPPA stated that based on para 5 and 15 of DPCO 2013, NPPA uploads the working sheet, if applicable, after notification of the retail price.

However, on the issue of GST, the regulatory body added that it has noted the issue raised by the firm and the same may be looked into based on the direction of DoP and submission of the requisite documents by the firm.

After going through the entire case the, DOP directed

NPPA is hereby directed to refix the retail price of Baclofen Oral Solution after factoring effective (5%) GST rate, within a period of one month from the date of issue of the order.
Issued on this date, the 10th day of January, 2019.

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