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Gireesh Babu, New Delhi February 21 , 2024
The Department of Pharmaceuticals (DoP) has rejected the review application of Mumbai-based Samarth Life Sciences Pvt Ltd and upheld the National Pharmaceutical Pricing Authority's (NPPA) ceiling price fixation for various strengths of muscle relaxant Atrapure, observing that the drug price regulator has followed the provisions as per the regulations.

The company filed a review application on April 28, 2023 against the NPPA notification on March 31, 2023, which fixed the ceiling price of Atrapure 100 mg injection 10 ml, Atrapure injection 25 mg injection 2.5 ml and Atrapure 50 mg injection 5 ml containing Atracurium injection 10 mg per ml. The ceiling price was fixed along with 126 other scheduled formulations.

Samarth Life Sciences alleged that the calculation of ceiling price for Atracurium injection 10 mg per ml in December, 2016 was based on a product pack of 10 mg/ml. The formulation Atrapure 100 mg injection 10 ml, Atrapure injection 25 mg injection 2.5 ml, and Atrapure 50 mg injection 5 ml are not sold in packs of 10 mg but rather 10 mg/ml and therefore, pricing a liquid injection on the basis of each pack is arbitrary.

According to the Drugs (Prices Control) Order, 2013, the average price to retailer calculated as per certain provisions in the Order shall be on dosage basis and the ceiling price or retail price of a pack shall be reached by multiplying the same with the number or quantity in the pack as the case may be. In the light of this, the company referred to the provisions of National List of Essential Medicines (NLEM) 2022 which specifies Atracurium injection 10 mg/ml and not a powder for injection which disregards the level of dilution.

It averred that the ceiling price calculation of Atracurium injection 10 mg/ml must be on the basis of each ml and not each pack. The ceiling price calculation of Atracurium injection 10 mg/ml must only include injection brands having strength "10 mg/ml''.

NPPA argued that the ceiling price of Atracurium injection 10 mg/ml is notified as Rs. 15.14 per ml on March 31, 2023, which has been revised at Rs. 16.97 with effect from April 1, 2023 after Wholesale Price Index revision. All the items and brands considered in the draft working sheet have a strength of 10 mg/ml as mentioned in the DPCO, however, the pack sizes are different at 2.5 ml, 5 ml and 10 ml. The Authority clarified that the data considered for ceiling price fixation is correct.

The subject formulation, i.e. Atracurium injection 10 mg/ml listed in section 1.4.1 in NLEM 2022, is a common formulation which was also covered in NLEM 2011 and NLEM 2015.

The ceiling price was notified under NLEM, 2011 as Rs. 45.28 for each pack on June 14, 2013. The WPIs for 2013, 2014 and 2015 were applied and ceiling prices were notified accordingly as Rs. 48.41 , Rs. 49.99 and Rs. 48.64 for each pack through notifications on April 28, 2014, February 26, 2015 and March 2, 2016 respectively.

Further, under NLEM, 2015 the ceiling price was worked out on per pack basis and notified as Rs. 48.63 per pack December 22, 2016. The pack sizes considered in the working sheet were 2.5 ml and 5 ml. Also, PTR restriction was applied on a per pack basis.

The Authority said that the matter was placed in the 43rd Authority meeting on March 29, 2017 to discuss the revised ceiling price of Rs. 39.55 per ml against the notified price of Rs. 48.63 per pack based on the representations from the companies.

The matter was deliberated in detail and was rejected, it said. The WPIs for 2017, 2018, 2019, 2020, 2021 & 2022 was applied accordingly notified as Rs. 49.59, Rs. 47.56, Rs. 49.20, Rs. 51.30, Rs. 52.27, Rs. 52.55 and Rs. 58.21 for each pack between 2017 and 2021. The Authority also said that a review application from Sun Pharma Laboratories was also rejected by the DoP related to the price fixation.

The DoP's review authority after hearing both sides, said, "It has been claimed by the applicant that Non - Scheduled formulation of 4 mgl ml has also been taken for price calculations which has been denied by NPPA. The same has been confirmed from the draft working sheet uploaded by NPP A and the contention of NPP A is found to be correct."

Para 4 of DPCO provides that the ceiling price of the scheduled medicines is to be fixed by calculating a simple average of market prices of all brands of the drug which has a market share of 1 % or more. Further, under para 11 (1), DPCO also provides that the average Price to Retailer (PTR) shall be on a dosage basis (i.e per tablet, per capsule or injection in volume as listed in Schedule -I of DPCO).

It observed that the NPPA has adhered to both these provisions of DPCO. It has taken prices of the available brands fulfilling the criteria as laid down by DPCO and also notified unit price on per ml basis for the aforesaid scheduled drug.

The review authority concluded, "Through the detailed examination noted above, it is observed that, NPPA has appropriately followed the provisions of DPCO while fixing the ceiling price of Atrapure 100 mg injection 10 ml, Atrapure injection 25 mg injection 2.5 ml and Atrapure 50 mg injection 5 ml containing Atracurium injection 10 mg per ml," while upholding the NPPA's order and rejecting the company's review application.

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