Last Updated on October 26, 2024 by The Health Master
Metoprolol
In a significant blow to major pharmaceutical companies, the Department of Pharmaceuticals (DoP), Govt of India (Govt) has upheld the ceiling price fixed for various strengths of modified release (MR) formulations of the high blood pressure drug metoprolol.
Despite strong arguments from companies like AstraZeneca and Lupin, the DoP rejected their review applications, reaffirming its commitment to controlling drug prices for essential medicines.
The Contention
Several leading pharmaceutical companies, including AstraZeneca, Lupin, Macleods Pharmaceuticals, Ajanta Pharma, and Primus Remedies, had challenged the DoP’s decision to fix the ceiling price for metoprolol MR formulations.
They argued that the pricing methodology adopted by the National Pharmaceutical Pricing Authority (NPPA) was flawed and discriminated against MR formulations.
AstraZeneca’s Argument
AstraZeneca, in particular, contended that the National List of Essential Medicines (NLEM) 2022 listed metoprolol 25 mg, 50 mg, 100 mg, and metoprolol modified release 100 mg, but did not include metoprolol modified release 25 mg and 50 mg.
The company argued that the NPPA had erred in combining both plain and MR formulations of metoprolol 25 mg and 50 mg tablets, resulting in an unfair pricing calculation.
NPPA’s Defense
The NPPA, however, defended its pricing methodology, stating that it followed a consistent approach for pricing both MR and conventional variants of drugs.
The authority explained that when an MR variant is specifically mentioned in a formulation, only the data for that variant is considered for price fixation.
However, in the absence of such a specific mention, both conventional and MR variants’ data can be used.
DoP’s Decision
After carefully considering the arguments from both sides, the DoP sided with the NPPA.
The review authority agreed with the NPPA’s assessment that the MR variants of metoprolol were an integral part of essential and lifesaving drugs and should remain under price control.
Moreover, the DoP noted that the market share for the MR formulations of metoprolol was significantly higher than that of the conventional formulations.
Deregulating the MR variants would have given pharmaceutical companies undue pricing power, potentially harming patients.
In conclusion, the DoP’s decision is a significant victory for consumers, as it ensures that the essential drug metoprolol remains affordable for a large segment of the population.
By upholding the ceiling price, the DoP has reaffirmed its commitment to regulating drug prices and protecting public health.
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.
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