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The Department of Pharmaceuticals (DoP) has rejected review applications from five companies including AstraZeneca and Lupin while upholding the ceiling price fixed for various strengths of modified release (MR) formulations of high blood pressure drug metoprolol.
AstraZeneca, Lupin, Macleods Pharmaceuticals, Ajanta Pharma, and Primus Remedies approached the DoP with separate review applications against the ceiling price fixation of the formulation, with similar arguments related to the price fixation of the extended or modified release format.
AstraZeneca, which approached the Department for its metoprolol 25 mg and 50 mg formulations, argued that the National List of Essential Medicines (NLEM) 2022 lists metoprolol 25 mg, 50 mg, 100 mg and metoprolol modified release 100 mg, but does not contain metoprolol modified release 25 mg ad 50 mg.
It alleged that while NPPA has notified separate ceiling prices for both metoprolol 100 mg tablets and modified release 100 mg tablets, while the price of modified release 25 and 50 mg were calculated equal to the conventional release formulation.
It argued that NPPA appears to have erred in combining both plain formulation and modified release formulations of metoprolol 25 mg and 50 mg tablets and requested the review authority to review the price revision of these two strengths of modified release tablets of the formulation and remove the ceiling prices for these products.
NPPA argued that the methodology approved and followed for pricing of modified release variant or conventional variant is that wherever MR variant is specifically mentioned in any formulation, the data of only MR variants may be considered for fixation of ceiling price. However, where MR variant is not specifically mentioned, data of conventional as well as MR variants may be considered for ceiling price fixation. This is in line with methodology of NLEM, 2015 also.
Similarly, where dispersible tablets, effervescent, soluble or tablets for direct application, etc., are specifically mentioned in any formulation, the data of only such variants may be considered. However, in absence of any variant being specifically mentioned, these variants may be considered along with conventional form, it added.
"The MR variants form an integral part of essential and lifesaving drugs and taking them out of price control is not the objective of SNCM (Standing National Committee on Medicines)," added NPPA.
It added that for metoprolol tablet 25 mg and 50 mg, plain and conventional moving annual turnover (MAT) is at Rs. 35.24 crore and Rs. 39.76 crore, respectively, while for the MR formulations, the same is Rs. 197.53 crore and Rs. 234.77 crore respectively. This means that in the 25 mg and 50 mg strengths, almost 84.86 per cent market share and 86.46 per cent market share, respectively, are for modified release tablet and if these forms are not considered to be scheduled as contented by the company, majority of the market will become deregulated, which is not the intent of NLEM, 2022.
Agreeing to the arguments of NPPA, the review authority upheld its ceiling price fixation and rejected the review applications.
It may be noted that the DoP has recently rejected the review application of Pfizer Ltd against ceiling price fixation of Wysolone DT, containing steroid drug prednisolone, with similar observations.
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