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DoP rejects review application of Neon Labs to revise ceiling price of steroid drug methylprednisolone
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Gireesh Babu, New Delhi
November 26 , 2024
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The Department of Pharmaceuticals (DoP) has rejected an application of Mumbai-based Neon Laboratories to review the National Pharmaceutical Pricing Authority's (NPPA) ceiling price fixation for steroid drug methylprednisolone injection 40 mg/ml.
The company approached the review authority after NPPA fixed the ceiling price of the drug, used for managing various health conditions including rheumatic disorders, asthma and allergic conditions, on April 24, 2023.
While fixing the ceiling price, the NPPA has considered the price of two of its drugs - Neodrol 40 mg injection 1ml containing methylprednisolone sodium succinate and Premaxo 40 mg/ml containing methylprednisolone acetate.
The company argued that while the Schedule I of DPCO, 2013 includes methylprednisolone 40 mg/ml injection, it has not explicitly included methylprednisolone acetate 40 mg/ml injection, and it must be construed as a non-schedule formulation.
Methylprednisolone sodium succinate is administered through injection in the bloodstream and is usually prescribed for emergency treatment whereas methylprednisolone acetate is administered through intramuscular or intra-articular route for long-term pain management. Thus, the two products differ with respect to the route of administration and medical indication, it added.
The ceiling price calculation of methylprednisolone 40 mg/ml must only include injections containing methylprednisolone 40 mg/ml and not methylprednisolone acetate having the same strength, argued the company.
The present calculation is in direct violation of the amended DPCO, which explains that the innovation in medicine must be encouraged, and formulations developed through incremental innovation or novel drug delivery systems like lipid/liposomal formulations should be considered only if specified in the list against any medicine.
NPPA, in its argument, said that methylprednisolone injection 40 mg/ml was listed in the National List of Essential Medicines (NLEM), 2015 and in the 2022 list. According to the explanation of DPCO, 2013, in case a medicine is available in more than one salt without any significant difference in potency/pharmacokinetics/pharmacodynamics/ efficacy-safety profile aspects, it indicates that these salts are therapeutically similar.
Therefore, all salts of such medicines with specified dosage form and strength are considered included in the schedule and in cases where the different salts of a medicine have significant differences in these characteristics, the medicine has been mentioned in the schedule with respect to its specific salt.
NPPA argued that in the present case, the methylprednisolone sodium succinate and methylprednisolone acetate are not separately mentioned in Schedule I of DPCO, 2013 and therefore, ceiling price fixed considering all salts as per practice and precedence.
The review authority accepted the arguments and logics given by NPPA and decided in an order dated November 18, that, "The action of NPPA fixing the ceiling prices of subject formulation is upheld and the Review Application under consideration is accordingly rejected."
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