After taking into account the arguments made by Sanofi India Ltd, the Organization of Pharmaceutical Producers of India (OPPI), and the US-India Strategic Partnership Forum, the National Pharmaceutical Pricing Authority (NPPA) has established separate ceiling prices for insulin glargine 100 IU/ml formulation in disposable pens as compared to vials and cartridges (USISPF). The National List of Essential Medicines (NLEM) 2022 now includes 100 IU/ml of insulin glargine. The Medicines (Prices Control) Order, 2013’s new Schedule I has recently been updated to include the NLEM 2022, and the NPPA is using this update to adjust or fix the formulations’ ceiling price.
According to the Authority, it has received comments from Sanofi India, OPPI, and USISPF regarding the consideration of vials, cartridges, and disposable pens separately, stating that only vials constitute a conventional form of injection and that only these should be taken into account when determining a formulation’s scheduled status. Unless otherwise noted, the cartridges and pens are innovative drug delivery devices and should not be included under the ceiling. The industry representatives claimed that even if these were thought of as scheduled, distinct ceiling pricing may still be established.
As it fixed the ceiling prices for several scheduled formulations at its most recent meeting on March 29, 2023, the NPPA carefully considered the issue and determined that, as long as vials, cartridges, and pens contain the scheduled formulation of insulin glargine 100 IU/ml, none of these various delivery models can be thought of as falling outside the ceiling price because the NLEM only lists insulin glargine 100 IU/ml as a scheduled formulation. They are simply different ways to package or deliver the planned formulation, it was noted. Moreover, both the cartridge and the vial contain multiple doses and are administered using tools like an injection/pen. Therefore, it said, these might not be regarded as separate.
Nonetheless, the Authority noted that a novel, inventive delivery system can be taken into account for separate pricing and that the disposable pen was claimed to be distinct from a vial in terms of convenience, emergency use, and improved compliance. Also, it was revealed that whereas disposable pens account for only 17% of market sales, vials and cartridges account for about 83% of it. The representation of an insulin user who claimed that there is a sizable price differential between insulin sold in vials and through other delivery systems was also taken into account by the Authority.
Following discussion, the Authority determined that the single ceiling price for vials and cartridges of insulin glargine 100 IU/ml would be set at Rs 181.45 per ML. It has set a price of Rs 217.74 per ML for the disposable pens for insulin glargine 100 IU/ml. According to the Authority, “this has been worked out by allowing additional 20% increase above the ceiling price of insulin glargine 100 IU/ml vials and cartridges, i.e. Rs. 181.45 per ml, on account of incremental innovation/novel drug delivery system in line with previous practise of the Authority.”
The Wholesale Price Index (WPI) rise of 12.128% in accordance with the NPPA’s decision on March 27, 2023 is applied before the ceiling prices are announced. In a conference conducted on March 29, 2023, the cost of insulin glargine was fixed together with the costs of more than 160 other scheduled formulations. Out of the entire 659 formulations for which the amended or freshly fixed draught ceiling prices were submitted by the Authority from November 25, 2022, the NPPA has approved the ceiling prices for about 481 formulations in previous meetings.
