NPPA Panel Fixes Retail Price Of Sachet containing Pantoprazole 40mg marketed by Alkem

The retail price of each sachet of 5gm finished formulation containing Pantoprazole 40mg manufactured and marketed by Alkem Laboratories has been set at Rs. 9.05 excluding GST.

This recommendation came during the 46th meeting of the Multidisciplinary Committee of Experts held on October 19, 2022, where the issue of retail price fixation of each sachet containing Pantoprazole Sodium Eq. to Pantoprazole 40mg (Sodium Bicarbonate as buffer) manufactured and marketed by Alkem Laboratories under Para 5 of the DPCO, 2013 was deliberated.

Pantoprazole is a first-generation proton pump inhibitor (PPI) used for the management of gastroesophageal reflux disease (GERD), for gastric protection to prevent recurrence of stomach ulcers or gastric damage from chronic use of NSAIDs, and for the treatment of pathological hypersecretory conditions including Zollinger-Ellison (ZE) Syndrome. It can also be found in quadruple regimens for the treatment of H. pylori infections along with other antibiotics including amoxicillin, clarithromycin, and metronidazole, for example. Its efficacy is considered similar to other medications within the PPI class, including omeprazole, esomeprazole, lansoprazole, dexlansoprazole, and rabeprazole.

Pantoprazole exerts its stomach acid-suppressing effects by preventing the final step in gastric acid production by covalently binding to the sulfhydryl groups of cysteines found on the (H+, K+)-ATPase enzyme at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion, irrespective of the stimulus. As the binding of pantoprazole to the (H+, K+)-ATPase enzyme is irreversible and a new enzyme needs to be expressed in order to resume acid secretion, pantoprazole's duration of antisecretory effect persists longer than 24 hours.

A sachet is a dosing unit that contains a solid pharmaceutical preparation in the form of a small packet or bag made from a flexible, often porous material.

At a recent Multidisciplinary Committee of Experts meeting, the panel noted that the matter was deliberated in the 45th meeting of the Multidisciplinary Committee of Experts held on September 13, 2022, where the retail price of Rs. 7.30 per tablet excluding GST calculated for Pantoprazole 40 mg tablet was extended to Sachet containing Pantoprazole Sodium Ed. to Pantoprazole 40 mg (Sodium Bicarbonate as buffer).

This was done because the Committee was of the opinion that there is no variation in the route of administration between tablet and sachet and that both the dosage forms can be considered similar from a therapeutic point of view.

In response to the above, the drug maker, Alkem Laboratories Limited, represented by letter dated 26.09.2022, stated that their formulation is different from conventional tablets in view of low-RH area, micronized Active Pharmaceutical Ingredient (API), special equipment used for the drying process of excipients, filling, sealing and nitrogen purging in sachets, special packing materials, benefits of pan insta technology etc.

In continuation with this, the matter was also placed before the Authority in its 102nd meeting held on 27.09.2022 in which the Authority noted the representation of Alkem Laboratories Ltd and decided that the matter be referred back to the Committee of Experts for examination of the representation.

Furthermore, Alkem Laboratories also submitted a letter dated 07.10.2022 and its e-mail dated 08.10.2022 requesting consideration of the equivalence of pantoprazole sachet with Omeprazole Sachet and the equivalence of Omeprazole Tab/Capsules with Pantoprazole Tab/Capsules for calculation of retail price.

Alkem Laboratories Ltd gave a presentation before the committee through Video Conference (VC) on their claim made vide representation dated 26.09.2022 & 08.10.2022 of their formulation.

In light of the presentation made by Alkem Laboratories, the Committee agreed that the formulation Pantoprazole powder for oral suspension may be useful in patients who have difficulty swallowing tablets, like patients with dysphagia, oesophageal strictures, recent radiation or chemotherapy.

The Committee further noted that the formulations "Pantoprazole" and "Omeprazole" are in the same therapeutic category and, accordingly, the retail price of Pantoprazole Sachet can be calculated based on the equivalent pricing structure/drug contents/dosage type and strength as that of Omeprazole. Therefore, the committee recommended the retail price of each sachet containing Pantoprazole Sodium Ed. to Pantoprazole 40mg (Sodium Bicarbonate as buffer) for Alkem Laboratories Ltd. (Manufacturer & Marketer) as below:

a. Application ceiling price of Omeprazole 20mg tablets as on November 2021 = Rs 4.94 per tablet excluding GST [SO.1330(E) dated 25.03.2021]