Last Updated on December 1, 2024 by The Health Master
Methylprednisolone
In a recent development, Mumbai-based Neon Laboratories has faced a setback in its appeal against the National Pharmaceutical Pricing Authority’s (NPPA) decision to fix a ceiling price for methylprednisolone injection 40 mg/ml.
The Department of Pharmaceuticals (DoP) has dismissed the company’s review application, upholding the NPPA’s pricing order.
The Disputed Drug: Methylprednisolone Injection
Methylprednisolone injection is a crucial medication used to manage a range of health conditions, including:
- Rheumatic disorders
- Asthma
- Allergic conditions
The Core of the Dispute
The crux of the dispute lies in the interpretation of the Drugs Price Control Order (DPCO) 2013.
Neon Laboratories argued that:
- Methylprednisolone acetate 40 mg/ml injection, which is a different formulation from methylprednisolone sodium succinate, should not be included in the price calculation.
- The two formulations have distinct routes of administration and medical indications.
- The DPCO 2013 promotes innovation in medicine and encourages the development of novel drug delivery systems.
NPPA’s Stance
The NPPA, however, countered these arguments, stating that:
- Methylprednisolone injection 40 mg/ml is listed in the National List of Essential Medicines (NLEM) 2015 and 2022.
- The DPCO 2013 considers therapeutically similar salts of a medicine as included in the schedule, even if not explicitly mentioned.
- In the case of methylprednisolone, both sodium succinate and acetate forms are considered therapeutically similar.
The Review Authority’s Decision
After careful consideration of both sides’ arguments, the review authority sided with the NPPA.
The authority concluded that:
- The NPPA’s decision to fix the ceiling price was justified.
- The review application filed by Neon Laboratories was rejected.
Key Takeaways
- The NPPA’s decision to fix a ceiling price for methylprednisolone injection 40 mg/ml has been upheld.
- The pharmaceutical industry must carefully consider the implications of the DPCO 2013 when developing and pricing new drugs.
- Patients can expect to benefit from lower prices for this essential medication.
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What is methylprednisolone injection used for?
Methylprednisolone injection is a potent corticosteroid medication used to treat various inflammatory conditions, including autoimmune diseases, allergic reactions, and severe asthma attacks.
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What is the difference between methylprednisolone sodium succinate and methylprednisolone acetate?
While both are forms of methylprednisolone, they differ in their onset of action and duration of effect. Sodium succinate has a rapid onset and shorter duration, making it suitable for acute conditions, while acetate has a slower onset and longer duration, making it suitable for chronic conditions.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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