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DoP rejects Intas Pharma’s review petition against ceiling price fixation on Globucel M
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Gireesh Babu, New Delhi
December 07 , 2022
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The Department of Pharmaceuticals (DoP) has rejected a review application by Ahmedabad-based Intas Pharmaceuticals for the review of the ceiling price fixed by National Pharmaceutical Pricing Authority (NPPA) for its brand Globucel M.
NPPA through a notification on April 18, 2022, fixed the retail price of Globucel M containing human normal immunoglobulin for intravenous use IP 5% solution (Ig M Enriched) for the company at Rs. 177.85 per ml excluding GST. The company raised its objection towards the retail price fixed, through a review application filed on April 28, 2022.
The company requested the DoP to set aside the NPPA's notification and fix the retail price of the product at Rs. 5,171.73, on the basis of price to retailers of Pentaglobin, which is already available in the market.
The company argued that the product Globucel M is an identical plasma therapeutic to the product Pentaglobin - which is manufactured by Biotest Pharma - having exactly the same formulation, specification product profile and quality attributes including all important parameters like double immunodiffusion, immunoelectrophoresis, PH, osmolality, total protein and protein composition, among others. As per the provision of Drugs (Prices Control) Order (DPCO), 2013 the retail price of a new drug available in the market has to be calculated in accordance with the Para 5(1) of the Order, which specifies the methods to calculate prices of such drugs.
The company argued that its product is identical with Pentaglobin which is already available in the market at retail price of Rs. 6,299. This should have been the basis of averaging the price of retailers of all the brands and generic versions of medicines having market share of more than or equal to one percent of total turnover on the basis of Moving Annual Turnover of that medicine, it said.
NPPA informed the Review Authority that the Human Normal Immunoglobulin 5% infusion is a scheduled formulation under DPCO, 2013 and the present applicable ceiling price is Rs 171.30 per ml excluding GST, according to its notification dated March 30, 2022.
The market data of the specific formulation from Intas Pharma was not appearing in the Pharmatrac data, which the Authority relies on for calculation of retail prices, and therefore the case was referred to the multi-disciplinary committee (MDC) of experts for consideration as to whether the specific formulation could also be a scheduled formulation as Human Normal Immunoglobulin 5% infusion, under the DPCO, 2013.
The company demonstrated its claim for significant therapeutic effect or clinical efficacy of its drug over the scheduled formulation in a meeting of the MDC and the claim of incremental innovation and advantage without increasing any side effect over normal human immunoglobulin 5% infusion was examined by the MDC in three meetings before granting an additional 15 per cent increase over the ceiling price of the scheduled formulation.
The company approached the MDC with a representation against the decision, but the MDC in its meeting held on February 25, 2022, reiterated its decision, submitted NPPA. Based on the MDC recommendation, the Authority, on March 24, approved the retail price of Globucel M at Rs. 177.85 per ml excluding GST.
The NPPA also argued that the formulation Pentaglobin was launched by Paviour Pharmaceuticals in 2012, before DPCO, 2013 and hence it had not approached the Authority for price fixation under DPCO, 2013. Based on the concerns raised by MDC, NPPA initiated necessary action under the provisions of DPCO, 2013 with respect of the formulation Pentaglobin 10 ml of Paviour Pharma and issued preliminary notice for suspected price violation during the period between July, 2016 to July, 2017.
Observing that the MDC has already granted 15 per cent increase over the ceiling price of Normal Human Immunoglobulin 5% applicable at that time for Intas Pharma's product and the NPPA has also issued preliminary notice to Paviour Pharmaceuticals for suspected price violation, the Review Authority decided to refuse the review application.
"The issue raised in the review application dated April 28, 2022, are devoid of merit and substance and hence the review application stands rejected. Issue of stay on overcharging amount does not come under the purview of DoP," said an order issued by Rajneesh Tingal, joint secretary to the Government of India, DoP.
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