The Department of Pharmaceuticals (DoP) has dismissed a request by Neon Laboratories, based in Mumbai, to re-evaluate the ceiling price determination set by the National Pharmaceutical Pricing Authority (NPPA) for the steroid medication methylprednisolone 40 mg/ml injectable.
Neon Laboratories reached out to the review board following NPPA’s decision to establish the drug’s ceiling price on April 24, 2023. This medication is commonly prescribed for conditions such as rheumatic disorders, asthma, and allergies.
During the pricing formulation, NPPA considered two medications: Neodrol 40 mg injection 1ml with methylprednisolone sodium succinate and Premaxo 40 mg/ml with methylprednisolone acetate.
The company contended that although the DPCO, 2013 Schedule I reflects methylprednisolone 40 mg/ml injection, it does not categorically include methylprednisolone acetate 40 mg/ml. Thus, according to Neon Labs, it should be treated as a non-scheduled formulation.
Methylprednisolone sodium succinate is typically administered intravenously for urgent care, whereas methylprednisolone acetate is given intramuscularly or intra-articularly for ongoing pain treatment. Consequently, there are variations between these medicines concerning their administration route and medical use, the company noted.
Neon Laboratories asserted that the methylprednisolone 40 mg/ml price calculation should exclusively encompass the corresponding injections and not the same strength of methylprednisolone acetate.
This current pricing method, as per the company’s argument, contravenes the revised DPCO guidelines, which emphasize fostering medical innovation. It stipulates that formulations resulting from incremental advancements or novel drug delivery methods should be recognized if designated on the list.
The NPPA justified its stance by indicating methylprednisolone injection 40 mg/ml is included in both the 2015 and 2022 editions of the National List of Essential Medicines (NLEM). Citing DPCO, 2013, it clarified that when a drug is available in multiple salts without notable pharmacological differences, these salts are deemed therapeutically similar.
It further explained that all medicinal salts within a designated dosage form and strength are assumed included unless significant differences exist, in which case the medicine appears in the Schedule with a specified salt.
The NPPA maintained that neither methylprednisolone sodium succinate nor methylprednisolone acetate are individually listed in Schedule I of DPCO, 2013. Thus, setting a ceiling price considering all salts aligns with established precedents.
The review authority acknowledged NPPA’s rationale and issued an order on November 18, affirming, “The NPPA’s action in determining the ceiling prices for the specified formulation is upheld, and the Review Application under consideration is summarily rejected.”