The Department of Pharmaceuticals (DoP) has disposed of the review application filed by Sun Pharma Laboratories Limited against notification SO 1687(E), dated 09.05.2016 issued by the National Pharmaceutical Pricing Authority (NPPA), fixing the ceiling price of Diltiazem 90mg capsules. The company filed the review application based on the direction/Order, dated 16.07.2019 passed by High Court of Delhi disposing of the WP (C) 6549/2019 filed by the company
Sun Pharma had earlier filed the review application with the reviewing authority, under paragraph 31 of the Drugs Price Control Order (DPCO), 2013 against the NPPA notification SO 1687(E), dated 09.05.2016 for fixing the ceiling price of Diltiazem 90mg capsules.
The company stated that 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.
Further the company said the price of conventional Diltiazem 90 mg capsule was notified, but not for Diltiazem 90mg SR capsule. Therefore, the price of sustained release (SR) capsule 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 company also requested 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.
The NPPA has erroneously considered the PTR of company’s two formulations, viz. Angizem 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 company said.
During the examination of the case, the DoP noted that the drug Diltiazem tablet was included in 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).
On clarification from the NPPA about the omission of 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.
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, but the fact remains that the notification was issued for Diltiazem 90mg capsules and not for SR Diltiazem 90mg capsules, the DoP noted.
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.
“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,” the DoP in its order said.