NPPA panel nod to15 percent hike in price of Otsuka Pharma 3 formulations

These three injectable formulations include Metronidazole Injection IP (0.5% w/v) 100ml, Mannitol Injection 20%, and Dextrose Injection (25% w/v) 100 ml, which have special features like self-collapsibility and self-seal ability, not having an air-vent and having no chance of contamination during manufacture / infusion / admixing levels.

This approval came in line with Otsuka Pharmaceuticals' application for a separate price under Para 11 (3) of the DPCO 2013 for the three injectable formulations listed above in non-glass packs with special features.

Otsuka Pharmaceutical India Private Limited (OPI) is a Joint Venture between Otsuka Pharmaceutical Factory, Inc., Japan and Mitsui & Co. Ltd., Japan for the Infusion Business in India and Emerging Markets which deals in infusion products across therapeutic segments, including infusion therapy, parenteral nutrition, anti-infectives, and plasma volume expanders. It offers injectables via various delivery systems, such as glass and plastic bottles (EURO Head & Nipple Head), ampoules, and non-PVC/PVC bags.

With respect to the Metronidazole Injection IP (0.5% w/v) 100ml, the Committee noted that it is a scheduled formulation whose ceiling price is fixed and the present applicable ceiling price is Rs.0.20 per ml excluding GST.

Further, the Committee observed that the formulation Metronidazole Injection IP (0.5% w/v) 100ml is the same as Metronidazole Injection 500mg/ml and is a scheduled formulation.

After observing the non-glass pack of Metronidazole Injection IP (0.5 percent w/v) 100ml of Otsuka Pharmaceuticals with special features such as Self Collapsibility and self-seal ability, not having an air-vent and having no chance of contamination during manufacture/ infusion/ admixing levels, the committee recommended,

"An increase of 15% over and above the ceiling present applicable ceiling price be allowed to M/s Otsuka Pharmaceuticals Pvt. Ltd for the product Metronidazole Injection IP (0.5% w/v) 100ml in non-glass having special features.

Accordingly, the Committee recommended the ceiling price of Rs. 0.23 per ml excluding GST for the formulation 'Metronidazole Injection IP (0.5% w/v) 100ml in non glass having special features' for 100 ml pack for M/s Otsuka Pharmaceuticals Pvt. Ltd.

The Committee also recommended that Wholesale Price Index (WPI), as applicable for scheduled formulation, on the ceiling price of Rs. 0.23 per ml excluding GST for the formulation 'Metronidazole Injection IP (0.5% w/v) in non-glass having special features' for 100 ml pack for M/s Otsuka Pharmaceuticals Pvt. Ltd."

Similarly, in the case of Mannitol Injection 20%, the Committee identified that Mannitol Injection 20% is a scheduled formulation with a predetermined ceiling price. The current applicable ceiling price, without GST, is Rs. 0.30 per ml.

The Committee also took note of Otsuka Pharmaceuticals' demonstration, indicating that the non-glass pack of Mannitol Injection 20 percent in the 100ml pack of Otsuka Pharmaceuticals has special features such as self-collapsibility and self-seal ability, not having an air-vent and having no chance of contamination during manufacture/ infusion/admixing levels.

In view of the above, the committee stated,

"The Committee deliberated upon the matter in detail and recommended that an increase of 15% over and above the ceiling present applicable ceiling price be allowed to M/s Otsuka Pharmaceuticals Pvt. Ltd for the product Mannitol Injection 20% in non-glass having special features for 100 ml pack.

Accordingly, the Committee recommended the ceiling price of Rs. 0.345 per ml excluding GST for the formulation 'Mannitol Injection 20% in non-glass having special features' for 100 ml pack' for M/s Otsuka Pharmaceuticals Pvt. Ltd.

The Committee also recommended that Wholesale Price Index (WPI), as applicable for scheduled formulation, on the ceiling price of Rs. 0.345 per ml excluding GST for the formulation 'Mannitol Injection 20% in non-glass having special features' for 100 ml pack for M/s Otsuka Pharmaceuticals Pvt. Ltd."

In a similar way, the committee reviewed the application for a separate price for Dextrose Injection (25 percent w/v) 100 ml in a non-glass pack with special features like (i) self-collapsibility and self-seal ability, (ii) not having an air-vent and (iii) having no chance of contamination during manufacture / infusion / admixing levels where the committee found that Glucose Injection 25 percent is a scheduled formulation with a fixed ceiling price.

The Committee observed the clarification provided by the Central Drugs Standard Control Organisation (COSCO) vide letter dated 13.08.2021 that Dextrose Injection 25% w/v and Glucose Injection 25% w/v are the same and the present applicable ceiling price of Glucose Injection 25% is Rs. 0.17 per ml excluding GST. Accordingly, the Committee concluded that Dextrose Injection 25% is a scheduled formulation .

Lastly, in light of the foregoing, in regards to the separate price of Dextrose Injection (25 percent w/v) 100 ml in the non-glass pack with special features committee proposed,

"The Committee deliberated upon the matter in detail and recommended that an increase of 15% over and above the ceiling present applicable ceiling price be allowed to M/s Otsuka Pharmaceuticals Pvt. Ltd for the product Dextrose Injection 25%% in non-glass having special features for 100 ml pack.

Accordingly, the Committee recommended the ceiling price of Rs. 0.195 per ml excluding GST for the formulation 'Dextrose Injection 25% in non-glass having special features' for 100 ml pack' for Mis Otsuka Pharmaceuticals Pvt. Ltd.

The Committee also recommended that Wholesale Price Index (WPI), as applicable for scheduled formulation, on the ceiling price of Rs. 0.195 per ml excluding GST for the formulation 'Dextrose Injection 25% in non-glass having special features' for 100 ml pack for M/s Otsuka Pharmaceuticals Pvt. Ltd."