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DoP rejects Sun Pharma’s petition to review ceiling price of Amphotericin B Liposomal 50mg injection
Arun Sreenivasan, New Delhi - Monday, July 2, 2018, 08:00 Hrs  [IST]
The Department of Pharmaceuticals (DoP) has turned down a review petition filed by Sun Pharma Laboratories against the ceiling price fixed by the National Pharmaceuticals Pricing Authority (NPPA) for its Amphotericin B Liposomal 50mg injection. The drug is used to treat serious and potentially life-threatening infections caused by fungus or protozoa.

The manufacturer, in a previous review petition, had contended that the national drug price regulator, while fixing the price of Amphotericin B Liposomal 50 mg injection, considered the incorrect price to retailer (PTR) of its product Lambin Injection 50 mg at Rs. 3000 per pack instead of Rs. 3610.90 per pack, the actual PTR in August 2015. It also stated that the prices of a few formulations having moving annual total (MAT) value less than 1 per cent market share were taken into consideration while fixing the ceiling price.
Subsequently, the DoP directed the NPPA to consider the PTR of those formulations having MAT value of more than 1 per cent market share. To implement the review order, the price regulator referred the matter to Pharmatrac. The market research agency has confirmed that the data being reflected is Rs. 3000 per pack and the PTR of Rs. 3610.90, as claimed by the company, is reported only once in August 2015. Hence, Pharmatrac captured the PTR of Rs. 3000 as the highest count.

According to the NPPA, the PTR having highest count as per Pharmatrac is to be taken for calculation of ceiling price of the formulation. Thus, the PTR of Rs. 3000 per pack being the highest count was taken for price calculation and the price of the formulation was changed from Rs. 3394.25 per pack to Rs. 3402.55 per pack as a result of the review.
The pricing authority further noted that the issue raised by the company was not new. “The same ground was raised in the earlier review petition and has been duly considered by the authority, as per the review order. A decision has been taken after going through all the reports and figures. The petitioner company cannot file review petition on an issue which has already been considered by the authority as a result of review order. The petition, therefore, needs to be rejected at the stage of admission itself,” the regulator argued.

The DoP endorsed the regulator’s stance and rejected the drug maker’s petition for price review. “Considering the PTR of the formulations of the company, which is in highest count, for ceiling price calculation is a logical and correct decision,” the department observed.


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