DoP orders NPPA to reassess price of Cipla’s Advent, Synclar and Azee drugs

Cipla submitted separate review applications for three drug formulations, challenging NPPA’s decisions on their price ceilings. The disputed products include Advent 1.2 gm Injection Powder – Amoxicillin 1000mg + Clavulanic Acid 200mg Synclar 125mg Dry Syrup – Clarithromycin 125mg per 5ml (30ml) Azee 250mg Tablet – Azithromycin 250mg (Pack of 6)

In each case, Cipla contended that errors in NPPA’s price fixation processes, specifically around pack sizes and pricing data, had resulted in inaccurately calculated ceiling prices for these drugs and requested re-calculations in line with DPCO provisions.

For Advent 1.2 gm Injection, Cipla argued that NPPA had incorrectly set the ceiling price based on outdated or incomplete data. Cipla provided evidence of an updated Price to Retailer (PTR) for Advent 1.2 gm, which was not reflected in the NPPA’s calculation. The company highlighted that their submissions, including Form-V and sales invoices, were in line with DPCO guidelines and established revised PTR at Rs. 111.52 per vial, whereas NPPA used Rs. 100.69, failing to account for pack size variation. Cipla also pointed out that the Pharmatrac database inaccurately recorded pack sizes, contributing to incorrect pricing.

In case of Synclar 125 mg Dry Syrup, Cipla argued that the NPPA did not revise the ceiling price accurately despite updated PTR information submitted in compliance with DPCO timelines. The company reported a PTR of Rs. 112.80 per 5 ml but found that the NPPA calculated the ceiling price based on Rs. 101.95 per 5 ml. Cipla noted that while they submitted updated information within the prescribed timelines, these were not integrated into the NPPA’s pricing calculation.

In context of Azee 250 mg Tablets, Cipla claimed that NPPA excluded their product from the ceiling price calculation due to outdated sales data, as reflected in the Pharmatrac database. The NPPA’s exclusion of Cipla’s Azee 250 mg tablet (pack of six) from its calculation of ceiling prices was based on zero recorded sales. However, Cipla confirmed that this SKU had been relaunched in March 2021, with updated PTR filings, and qualified for inclusion in NPPA’s data set. Cipla argued that the exclusion led to a misleading price ceiling for Azithromycin 250 mg tablets.

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In response, the NPPA emphasized adherence to the Drugs (Prices Control) Order (DPCO) 2013 regulations, explaining that the ceiling price calculation was based on the data available through the Pharmatrac database and the stipulated timeline for submission of Form-II and Form-V. NPPA contended that data entries were cross-referenced with Pharmatrac’s market data to ensure compliance with DPCO’s pricing regulations, and only brands meeting market share criteria were included. For the Azee tablet, the NPPA explained that data irregularities due to zero sales reporting in the database contributed to exclusion, despite Cipla’s reintroduction of the SKU.

To elaborate, for Advent 1.2 gm Injection Powder, NPPA clarified that under DPCO guidelines, manufacturers are allowed to revise prices annually in April, provided that they submit Form-II on time. However, NPPA noted differences in the pack sizes reported by Cipla, based on data from Pharmatrac, which impacted the ceiling price calculation.

In the case of Synclar 125mg Dry Syrup, NPPA acknowledged that Cipla had indeed filed Form-II and Form-V for the WPI-based revision on time. However, this timely submission had been overlooked during NPPA’s initial ceiling price calculations.

For Azee 250mg Tablet, NPPA confirmed that Cipla had submitted Form-II within the required timeframe. Nevertheless, Pharmatrac’s database failed to capture sales of the Azee 250mg Tablet (Pack of 6) during the assessment period, possibly due to initial recording issues. Following Cipla’s representation and additional documentation, Pharmatrac later validated that the product had been reintroduced in 2021, and NPPA recognized the need to include this updated data in its calculations.

The Department examined Cipla’s pricing issues across three drugs, and accordingly directed NPPA to make necessary corrections in line with DPCO guidelines. For Advent 1.2 gm Injection Powder, DoP noted inconsistencies between pack sizes in Pharmatrac’s database and Cipla’s submissions, instructing NPPA to re-evaluate the ceiling price based on Cipla’s documented PTR adjustments. It held;

“It is noted that M/S Cipla Limited filed two Form-Ils on 02.05.2022 i.e. one for Advent 1.2gm Inj Vial and one for Advent 1.2gm 20ml Inj claiming revised PTR of Rs. 111.52 for both. Company had also submitted two Form-Vs on 07.05.2022 in line with FormIIS. There is a difference in pack size as captured by Pharmatrac database and pack size reported by the Applicant in Form-Il. As the pack size reported in Form-Il was not reflected in Pharmatrac data, the price revision in pack sizes reported by the Applicant through Form-Il was not considered for price calculation. Therefore, in the present case, NPPA may relook into the issue and examine with respect to pack size as available in Pharmatrac and contention of the Applicant regarding pack size and revise the ceiling price on the basis of extant provisions of DPCO, 2013.”

“In the backdrop of these facts, the case is referred back to NPPA for re-examination and re-calculation of the prices of the subject formulation as per the extant provisions of DPCO, 2013.”

In the case of Synclar 125mg Dry Syrup, due to Cipla’s timely submission and NPPA’s confirmation of an oversight, the pharma department has sent the case back to NPPA, directing a recalculation that incorporates the updated PTR of Rs. 112.80. It said;

“It is noted that Forms-Il and Form-V were filed within stipulated time by M/S Cipla Limited. However, inadvertently, the same have not been considered in calculating the PTR. Accordingly, revisions may be carried out by NPPA in the P TR. NPPA may once again look out for all such possible errors in calculation of ceiling price.”

“In the backdrop of these facts, the case is being referred back to NPPA for recalculation of ceiling price for the formulation clarithromycin 125mg per 5ml as per extant provisions of DPCO, 2013.”

Finally, for Azee 250mg Tablet, the Department recognized the inaccuracies highlighted by NPPA and instructed a re-evaluation of the ceiling price using Pharmatrac’s corrected data, ensuring all adjustments are accurately reflected. It noted;

“NPPA’s has confirmed the filing of Form-Il by the applicant within the time limits prescribed under extant provisions of DPCO 2013. Further, anomalies in Phramatrac database and their requisite corrections as submitted by NPPA have also been noted. In view of these facts, the ceiling price of the formulation requires revision. NPPA may once again look for all such possible errors in calculation of ceiling price.”

“In the backdrop of these facts, the case is being referred back to NPPA for recalculation of ceiling price for the formulation Azithromycin 250mg tablet as per extant provisions of DPCO, 2013.”