DoP rejects application challenging NPPA price fixation order on Metoprolol

Ajanta Pharma filed the review plea under Para 31 of the Drugs (Prices Control) Order, 2013 against the order issued on 06.01.2023 by the NPPA. The order fixed the ceiling price of Metoprolol Tablet 25mg and Metoprolol Tablet 50mg.

Following the submission, the Department of Pharmaceuticals sought clarification from NPPA, leading to a hearing on June 1, 2023, where both parties presented their arguments.

Ajanta Pharma contended that NPPA has erred in determining the ceiling price of the said drug and hence may be directed to revise the same.

The drugmaker challenged the impugned notification in respect of ceiling price fixation of Metoprolol Tablet 25mg and Metoprolol Tablet 50mg issued by NPPA as improper, misconceived as it has been carried out erroneously, arbitrarily, without jurisdiction by NPPA, in mechanical manner with wrongful inclusion of formulations manufactured by the Applicant, namely Met XL 25mg Tablet ER 20 (Metoprolol 25mg Tablet Extended Release) and Met XL 50mg Tablet ER 20 (Metoprolol 50mg Tablet Extended Release) having modified dosage, incremental innovation and novel drug delivery system.

Ajanta submitted that it made representation to NPPA on December 8, 2022 within stipulated time against draft version displayed on its website on December 1, 2022, in respect of calculation of Metoprolol 25mg Tablet for wrongfully including formulation Met XL 25mg Tablet ER 20 (Metoprolol 25mg Tablet Extended Release) and Metoprolol 50mg tablet for wrongful inclusion of Met XL50 mg Tablet ER 20 (Metoprolol 50mg Tablet Extended Release), respectively, for ceiling price fixation under revised Schedule-I of DPCO, 2013 as the said formulations manufactured by the firm are distinct, separate and different and cannot be equated with the plain conventional Tablets.

Sl. no.	Name of formulation	Scheduled	Dosage form and Strength	Unit	Ceiling Price in IQs.
8	Metoprolol		Modified Release Tablet 100 mg.	I Tablet	13.37
9	Metoprolol		Tablet 100 mg.	1 Tablet	9.93

Consequently, Metoprolol tablet in plain/ conventional dosage cannot be clubbed with modified release dosage as it would amount to be unreasonable, ultra vires, illegal, anomalous and not tenable.

Prior to aforesaid amendment of the DPCO, 2013 on 11 November 2022, earlier amendment in DPCO, 2013 was done via order dated 10^th March 2016 in Schedule-I on the basis NLEM, 2015 wherein Metoprolol tablet was listed at item no, the petitioner mentioned in its submission.

Additionally, it pointed out that in existing aforesaid Schedule-I of the DPCO 2013, Metoprolol 25mg and Metoprolol 50mg plain tablets and sustained release tablets were specified separately and as under:

Schedule-I National List of Medicines (NLEM) 2015

Section 12- Cardiovascular Medicines

12.1 Medicine used in Angina
	Medicine	Level of health care	Dosage form(s) and strength(s)
12.1.7	Metoprolol	P, S, T	Tablet 25mg Tablet 50mg SR Tablet 25mg SR Tablet 50mg

It claimed that NPPA had notified separate ceiling prices of Metoprolol formulations plain/conventional tablets and modified dosage sustained release (SR) vide SO. 1499 (E) dated 30.03.2022, as under-

Sl. No.	Name of Formulation	Dosage and strength	Unit	Ceiling price in Rs.
561	Metoprolol	Capsule 25mg	I Capsule	4.70
562	Metoprolol	Capsule 50mg	I Capsule	7.16
563	Metoprolol	SR Tablet 25mg	1 Tablet	4.47
564	Metoprolol	SR Tablet 50mg	1 Tablet	6.41
565	Metoprolol	Tablet 25mg	1 Tablet	3.46
566	Metoprolol	Tablet 50mg	1 Tablet	5.24

The National Pharmaceutical Pricing Authority (NPPA) has recognized that plain conventional Metoprolol tablets are distinct from sustained-release (SR) and extended-release (ER) formulations by setting separate ceiling prices for each, as outlined in Schedule-I of the National List of Essential Medicines (NLEM, 2015), the petitioner stated, adding that pricing for controlled-release formulations should only be considered if explicitly listed.

It referred to the Hon'ble Supreme Court, in a 2019 ruling, that acknowledged the DPCO's awareness of different drug delivery systems, noting that modifications in drug release can enhance stability, safety, and efficacy. The Court defined "sustained release" as a system that maintains a consistent rate of drug release over time. Additionally, the Delhi High Court ruled that price notifications for conventional tablets do not apply to controlled-release formulations.

The pharma firm claimed that it is suffering significant losses due to what it considers arbitrary price fixation in the notification dated January 6, 2023. Therefore, it requested the reviewing authority to withdraw this notification regarding Metoprolol 25mg and 50mg Extended Release formulations or amend it appropriately.

NPPA on the other hand argued that the instant review is not tenable as that the pricing methodology followed was appropriate. According to NPPA, if a modified release variant is not specifically mentioned, both conventional and modified release data could be included in the pricing calculations. This approach aligns with the methodology outlined in the National List of Essential Medicines (NLEM) 2015, which aims to ensure the availability of essential drugs.

The methodology approved and followed for the pricing of MR Variant/Conventional Variant by the Authority read;

"Wherever, MR variant is specifically mentioned in any formulation the data of only MR variants (CR, SR, XL, ER delayed release etc.) 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 DT/effervescent/soluble/MD, etc. is specifically mentioned in any formulation in any formulation the data of only such variants may be considered. However, in absence of any variant being specifically mentioned, the DT/ effervescent /soluble/MD may be considered along with conventional form.

It further said that the NLEM is prepared with the objective of satisfying the priority health care needs of the population. The list is made based on disease prevalence, efficacy, safety and comparative cost-effectiveness of the medicines. The aim behind formulating NLEM is to ensure that these medicines are available in adequate quantity, in appropriate dosage forms and strengths with assured quality. NLEM does recognize such innovations in drugs where substantial improvements, effectiveness and efficacy have been introduced either in terms of quality or in the delivery system or both. Accordingly, NLEM mentions such innovative drugs separately under different categories commonly named as Modified Release (MR) versions in the same list where such criteria are fulfilled. When the same is not mentioned separately, then all such varieties of such drugs for the specified dosages are considered to be part of variants appearing in the list. The objective of NLEM, inter alia, is to ensure availability of the essential drugs as well. This objective may be adversely affected by the exclusion of different variants from the NLEM based on criteria such as MR etc., as such exclusion may encourage essential drugs simply moving out of NLEM. This may not be in line with the spirit and purpose of including these drugs in the list of essential medicines in the first instance.

Subsequently, the Department upheld the action of NPPA fixing the ceiling price of Metoprolol Tablet 25mg and Metoprolol Tablet 50mg via order dated 06.01.2023. The Review Application under consideration was accordingly rejected.