DoP directs NPPA to examine ceiling price of Sun Pharma hypertension drug Diltiazem

The order came while disposing of Sun Pharma's plea which was filed based on the direction given by the Delhi High Court via an order dated 16.07.2019.

In its review pleas, the drugmaker contented;

The drug Diltiazem tablet was included in Schedule-I of DPCO 2013 as 30mg, 60mg and SR tablet 90mg, Injection 5mg/ml vide DoP‟s SO 701(E), dated 10.03.2016. The price of conventional Diltiazem 90 mg capsule was notified, but not for Diltiazem 90mg SR capsule. Therefore, the price of SR capsules was required to be fixed separately by considering the rate of similar products i.e. SR capsules only as per the procedure made in para 4, para 9 of DPCO.

"The NPPA has erroneously considered the PTR of the company‟s two formulations, viz. Angie CD 90 and Angizem DP 90 capsules as Rs 78.53 (against actual PTR 82.36), which is much lower than the applicable PTR of August 2015," the contention read.

Further, the company also sought to direct the NPPA to withdraw Demand Notice, dated 8.5.2019 on Angizem CD 90 capsules and Demand Notice dated 22.5.2019 on Angizem DP 90 capsules, as the prices for these two formulations have not been notified.

Responding to the contentions; NPPA stated that the grievance of the company is a factual statement and offered no comments. Moreover, while calculation of ceiling price, PTR of formulations other than immediate-release formulations were considered. Therefore, the price fixed by NPPA is also applicable to the products Angizem DP 90 capsules and Angizem CD 90 mg. of Sun Pharma Laboratories Ltd.

NPPA further elaborated that it considered the PTR as provided by Pharmatrac for the period of August 2015 while fixing the ceiling price vide SO 1687(E), dated 9.5.2016 and the company did not file a review petition regarding the PTR of their products at that time.

After hearing both the parties, the court noted that the drug Diltiazem tablet was included in the revised Schedule-I (NLEM 2015) of DPCO 2013 as 30mg, 60mg, and "SR tablet 90mg".

However, in the price notification SO 1687(E), dated 9.5.2016, the NPPA notified the ceiling price of Diltiazem capsule 90mg and the phrase "SR" was omitted in the price notification, whereas while fixing the ceiling price, the NPPA has considered the PTR and MAT value of only Sustained Release (SR) formulations (other than immediate-release formulations).

Further, on clarification from the NPPA about the omission of the words „SR‟ in the price notification SO 1687(E), dated 9.5.2016, the NPPA admitted that words "SR" were inadvertently omitted in the price notification.

The court noted;

"In view of the above, the NPPA has erred in notifying the ceiling price of Diltiazem capsule 90mg instead of SR Diltiazem 90mg capsule. Although it is a fact that the NPPA, while notifying the ceiling price of Diltiazem capsule 90mg, has considered the data of formulations other than immediate-release formulations and considered only SR formulations, the fact remains that the notification was issued for Diltiazem 90mg capsules and not for SR Diltiazem 90mg capsules. 4.4 Considering the above facts, it is proposed that the NPPA needs to be directed to examine the case afresh and pass appropriate orders in respect of the subject formulation at S.No.19 of SO 1687(E), dated 09.05.2016."

Examining the company's demand to withdraw Demand Notice, dated 8.5.2019 on Angizem CD 90 capsules and Demand Notice, dated 22.5.2019 on Angizem DP 90 capsules, the court was of the view that as the issue of Demand Notices for overcharging is within the purview of the NPPA, the same can also be examined by the NPPA as per provisions of the DPCO.

Subsequently, DoP held;

"The NPPA is hereby directed to examine the case afresh and pass appropriate orders in respect of the formulation Diltiazem 90mg capsule at S.No.19 of SO 1687(E), dated 09.05.2016, within a period of thirty days of the issue of this order."

"As the issue of overcharging is within the purview of the NPPA, the NPPA is further directed to examine the matter of Demand Notices issued for overcharging as per provisions of DPCO," it added.

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