New Delhi : The National Pharmaceutical Pricing Authority (NPPA) has fixed the ceiling price for two medical devices – hormone releasing intrauterine devices (IUDs) and IUDs containing copper – under the Schedule I of the Drugs (Prices Control) Order, 2013, which was revised to include in the National List of Essential Medicines (NLEM), 2022.
The draft calculation sheet for these two device formulations was released on January 12, 2023 and the same was finalised in an Authority meeting held on February 21, after considering one representation received against the draft working sheet, said the drug price regulator.
Accordingly, the price of hormone releasing IUD containing 52 mg of levonorgestrel is fixed at Rs. 3,456.44 per unit, which is a 19.52% reduction from the prevailing ceiling price of Rs. 4,295.01 per one hormone releasing IUD. The device, which has a total moving annual turnover of Rs. 15.31 crore, has two players with a market share of one per cent or more.
The Authority has considered two products, brand Emily manufactured by public sector manufacturer HLL Life Care Ltd which had a price per unit of Rs. 2,704.80 per unit and brand Mireya IUS manufactured by Bayer Zydus Pharma Pvt Ltd, which has been selling at a price per unit of Rs. 3,254.58. Levodopa IUD, from Bharat Serums and Vaccines Ltd, which has a price of Rs. 3,048.90 per unit was not considered while fixing the price of the product. According to the NPPA draft sheet, Bayer Zydus Pharma has almost 95.85 per cent of the MAT, at Rs. 14.67 crore, while HLL Life Care has 4.15 per cent MAT at Rs. 63.58 lakh.
The ceiling price of IUD containing copper has seen a reduction of 21.5 per cent at Rs. 250.62 per IUD, as compared to the prevailing ceiling price of Rs. 319.22 per IUD.
In order to fix the ceiling price, the Authority has a considered the price of three packs from HLL Life Care – M-Care CU 250 mg (Rs. 240.24 per unit), M-Care 375 mg (Rs. 240.24 per unit) and T Care 380 mg (Rs. 159.60 per unit) – and one product TIUP CU 375 mg from Mylan with a price of Rs. 224.14 per unit. While Zydus Cadila has its brand Multiload 375 mg for the product, with a price of Rs. 460.80 per unit price, it was not considered by the Authority while fixing the price.
The IUD containing copper as a product has a moving annual total of Rs. 36.71 lakh and two players with a market share of one percent or above. HLL Life Care has brand-wise MAT of 89.29 per cent for the brand M-Care CU and 2.66 per cent for the brand T Care, while Mylan has brand-wise MAT of 8.05 per cent. The brand-wise MAT of Zydus Cadila and U Care CU from DKT India were zero, says NPPA.
The hormone releasing IUD and IUD containing copper were included in the NLEM 2011 and in the subsequent lists till NLEM, 2022. However, in the NLEM 2011, there was no specified dose for hormone releasing IUD while under NLEM, 2015, the strength 52 mg of levonorgestrel was specified. It is also mandatory for every manufacturer or marketer to mention the strength of levonorgestrel for this device, as per the pharmacopoeia and national formulary.
It may be noted that the NPPA has revised the ceiling price of 80 scheduled formulations and fixed the ceiling price of one formulation and fixed retail prices of 74 formulations under the DPCO, 2013, based on the decision of the Authority meeting on February 21, 2023.