NPPA Recommends 15% Rise In Ceiling Price For Otsuka’s 3 Formulations, Owing To Special Packing

New Delhi : An expert panel under the drug price regulator National Pharmaceutical Pricing Authority (NPPA) has recommended separate prices for Japanese pharma major Otsuka Pharmceuticals for its various injectable products, in non-glass packaging having special features.

A recently held multidisciplinary committee of experts in NPPA considered the application of Otsuka Pharma for a separate price for its special featured packaging. The company said that the non-glass pack of three injectable products have special features as self collapsibility and self-seal ability; not having air-vent; and having no chance of contamination during manufacturing/infusion/admixing levels.

The Committee, deliberating upon the application for a separate price under the relevant clause of Drug Price Control Order, 2013, recommended an increase of 15 per cent over and above the present applicable ceiling price to its antibiotic metronidazole injection IP (0.5% w/v) 100 ml in non glass having special features. The present ceiling price is Rs 0.20 per ml excluding Goods and Services Tax (GST), which is recommended to be Rs 0.23 per ml excluding GST.

It has also recommended that the wholesale price index, as applicable for scheduled formulation, on the ceiling price of Rs 0.23 per ml for the formulation.

Similarly for the scheduled formulation mannitol injection 20%, used to reduce intra-ocular pressure prior to ophthalmic procedures, in non-glass pack it has recommended a 15 per cent increase over and above the present applicable ceiling price for 100 ml pack. The mannitol injection 20% has a currently applicable ceiling price of Rs 0.30 per ml excluding GST.

The Committee observed that the non glass pack has special features as mentioned in the case of metronidazole injection. The ceiling price is now recommended to be of Rs 0.345 per mail excluding GST for 100 ml pack. The WPI is also applicable for the scheduled formulation on the new ceiling price.

The prices of dextrose injection (25% w/v) 100 ml in non-glass pack having special features, has also been recommended for a 15 per cent increase over and above the present applicable ceiling price. The committee observed the clarification provided by Central Drugs Standard Control Organisation (CDSCO) through letter dated August 13, 2021 that detrose injection 25% w/v and Glucose Injection 25% w/v, which is a scheduled formulation, are the same and the present applicable ceiling price of glucose injection 25% w/v is Rs 0.17 per ml excluding GST.

“Accordingly, the Committee concluded that dextrose injection 25% is a scheduled formulation. The committee also observed that the non-glass pack of dextrose injection 25% in 100 ml pack of Otsuka Pharmaceuticals Pvt Ltd have special features as (i) self collapsibility and self-seal ability, (ii) not having air-vent and (iii) having no chance of contamination during manufacture/infusion/admixing levels,” said the Committee in the 35th meeting held on August 18, 2021.

It has also recommended WPI as applicable for scheduled formulation, on the newly recommended ceiling price of Rs 0.195 per ml excluding GST.

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