Gujarat High Court
Sun Pharma Laboratories Limited vs National Pharmaceutical Pricing ... on 5 January, 2021
Author: Vipul M. Pancholi
Bench: Vipul M. Pancholi
C/SCA/1 6640/2020 ORDER IN THE HIGH COURT OF GUJARAT AT AHMEDABAD R/SPECIAL CIVIL APPLICATION NO. 16640 of 2020 SUN PHARMA LABORATORIES LIMITED Versus NATIONAL PHARMACEUTICAL PRICING AUTHORITY Appearance: MS MEGHA JANI(1028) for the Petitioner(s) No. 1 for the Respondent(s) No. 1,2 CORAM: HONOURABLE MR. JUSTICE VIPUL M. PANCHOLI Date : 05/01/2021 ORAL ORDER
Draft Amendment is allowed. Learned advocate for the petitioner to carry out the amendment, forthwith.
Heard learned advocate Ms.Megha Jani appearing for the petitioner.
It is submitted that the respondent No.1 issued a Notification S.O. 701 (E) on 10.03.2016 to include Diltiazem 30 mg tablet, 60 mg tablet, 90 mg sustained release (SR) tablet and 5 ml/mg injection as a Schedule-I, National List of Essential Medicines, 2015 formulation. Thereafter, on 29.03.2016, respondent No.1 fixed the ceiling price of Diltiazem 90 mg sustained release (SR) tablets by issuing Notification S.0O. No.1254(E). Thereafter, in May, 2016, respondent No.1 fixed the ceiling price of Diltiazem 90 mg conventional capsules by Notification S.0O. No.1687 (E). However, surprisingly, in September, 2017, the petitioner received a show-cause Page lof 4 Downloaded on : Thu Jan 07 00:27:55 IST 2021 C/SCA/1 6640/2020 ORDER notice from respondent No.1 alleging that batch number of BSR 2223 of Angizem DP was being sold by the petitioner for price of Rs.10.7 per capsule against notified ceiling price of Rs.8.91 per capsule and, thereby, overcharging customers for a particular period. Similar type of notice was received by the petitioner in April, 2018. The petitioner submitted its reply to the show-cause notice received by it. Thereafter, demand notice was issued by respondent No.1 alleging that the petitioner was liable to pay an overcharged amount along with interest. The petitioner challenged the same by filing a petition before the Delhi High Court. However, the _ said petition was disposed of by permitting the petitioner to file review before the competent authority. The petitioner preferred review application requesting the Department of Pharmaceuticals to direct respondent No.1 to fix a separate ceiling price for Diltiazem 90 mg sustained release (SR) capsules. The Department of Pharmaceutical passed an order in review whereby respondent No.1 was directed to examine the case afresh and pass appropriate orders in respect to Diltiazem 90 mg capsule and further directed to examine the matter of demand notices issued for overcharging to the petitioner.
It is submitted that now, respondent No.1 held 78°" meeting on 14.09.2020 wherein it was noted that ceiling price for conventional Diltiazem 90 mg capsule fixed by notification S.O. 1687 (E) was based on the data of sustained release (SR) variants and, Page 2of 4 Downloaded on : Thu Jan 07 00:27:55 IST 2021 C/SCA/1 6640/2020 ORDER therefore, the said notification was also applicable to all Diltiazem 90 mg sustained release (SR) capsules. Accordingly, review order dated 24.07.2020 was treated as closed. The petitioner, therefore, made representation to respondent No.2 and requested to direct respondent No.1 -- National Pharmaceutical Pricing Authority (NPPA) to rectify the mistake in the aforesaid notification as per the review order dated 24.07.2020 and thereafter pass appropriate orders. However, once again, on 24.11.2020, respondent No.1 in its 81°* meeting reiterated the decision taken in 78*" meeting.
Learned advocate for the petitioner has referred Schedule-I of the Drugs (Prices Control) Order, 2013 and more particularly, Item No.12.1.3 of the said Schedule. Thereafter, learned advocate has referred Explanation (1) given below Schedule-I. Learned advocate also referred the order dated 24.07.2020 passed by respondent No.2, by which, the review application filed by the petitioner came to be disposed of. Respondent No.2 has observed in Paragraphs-4.2 and 4.3 as under:-
"4.2 0On 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.
4.3 In view of the above, the NPPA has erred in notifying the ceiling price of Diltiazem capsule 90 mg instead of SR Diltiazem 90 mg capsule. Although it is fact that the NPPA, while Page 3o0f 4 Downloaded on : Thu Jan 07 00:27:55 IST 2021 C/SCA/1 6640/2020 ORDER notifying the ceiling price of Diltiazem capsule 90 mg, 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 90 mg capsules and not for _ SR Diltiazem 90 mg capsules."
It is submitted that in spite of the aforesaid observations, now in the impugned decisions taken by respondent No.1 on 14.09.2020 and 24.11.2020, it has been observed that ""...decided that review order no.31015/12/2019-Pricing dated 24.07.2020 be treated as closed...."
Considering the submissions canvassed by the learned advocate for the petitioner, issue Notice returnable on 22.02.2021.
Till the returnable date, there shall be ad-
interim relief in terms of Paragraphs-11(B) and (C).
(VIPUL M. PANCHOLI, J) piyush Page 4of 4 Downloaded on : Thu Jan 07 00:27:55 IST 2021