NPPA Fixes Ceiling Price Of Disposable pen containing insulin glargine

This came in line with the decisions of 111th Authority meeting dated 29.03.2023, where the ceiling price of scheduled formulation, Disposable Pen containing Insulin Glargine, was discussed under Para 11 of Drugs (Prices Control) Order, 2013 (NLEM 2022).

The Authority noted that Insulin Glargine 100 IU/ml has been newly added under NLEM 2022.

The Authority also took note of the representations made by Sanofi India, the Organisation of Pharmaceutical Producers of India (OPPI), and US-India Strategic Partnership Forum (USISPF), with respect to consideration of vials, cartridges and disposable pens separately stating that only that vials constitute conventional form of injection and these only should be considered as scheduled formulation.

The representation further added that the cartridges and pens are novel drug delivery system and should not be included under ceiling unless specifically stated specifically or even if these are considered as scheduled, separate ceiling price may be fixed.

In reference to the above, the Authority deliberated the matter in detail and decided,

"As long as vials, cartridges and pens contain the scheduled formulation Insulin Glargine 100IU/ml, none of these (cartridge, pen, vial) can be considered outside the ceiling price as NLEM states only Insulin Glargine 100 IU /ml as a scheduled formulation. These are just different means of packaging/ delivery of the scheduled formulation."

Furthermore the authority added,

"Both cartridges and vial are multi dose and administered through device like injection/pen. Hence, these may not be treated as distinct. The disposable pen as claimed to be distinct from vial in terms of convenience, emergency use and better compliance and an innovative novel delivery system can be considered for separate pricing."

It was also noted by the Authority that sales of vials and cartridges are around 83% of the market while disposable pens have sales of 17%. The representation of a user of insulin was also brought to the notice of the Authority who has pointed to the considerable price difference between insulin sold in vials and through other delivery systems.

After due deliberations, it was stated,

"The authority decided to fix a single ceiling price for Insulin Glargine 100IU/ml vials and cartridges at Rs.181.45 per Ml under Para 4 of DPC0 2013.

The Authority also fixed the ceiling price of Insulin Glargine 100IU/ml pens at Rs.217.74 per ml for pen. This has been worked out by allowing additional 20% increase above the ceiling price of Insulin Glargine 100IU/ml vials and cartridges i.e. Rs. 151.45 per ml on account of incremental innovation/ novel drug delivery system in line with previous practice of the Authority.

It was decided to notify the prices of Insulin Glargine 100IU/ml pens under Para 11 (3) of DPCO 2013."

In accordance with the aforementioned decision, the NPPA recently notified

" In exercise of the powers conferred by sub paragraph (3) and (4) of paragraph 11, 14 and 16 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated 30th May, 2013 and S.O. 5249(E) dated 11thNovember, 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority has fixed the ceiling prices exclusive of goods and services tax applicable, if any, as specified in column (5) and increased by Wholesale Price Index (WPI) of 12.1218% under para 16 (1) of DPCO 2013 , with effect from 1.04.2023 as specified in column (6)of the table in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the dosage form & strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:

The notice further added,

a) The above mentioned ceiling prices as fixed under NLEM 2022 shall be effective from 1st April, 2023 after application of Wholesale Price Index (WPI) and as specified in column (6) above.

(b) All manufacturers of scheduled formulation, selling the branded or generic or both the versions of scheduled formulations at a price higher than the ceiling price (plus Goods and Services Tax as applicable) so fixed and notified by the Government, shall revise the prices of all such formulations downward not exceeding the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any and Sl. No. Name of the Scheduled Formulation Dosage form and strength Unit Ceiling Price Fixed under NLEM, 2022 (Rs.) Ceiling price (wef 1.4.2023 with WPI @ 12.1218%)\ (1) (2) (3) (4) (5) (6) 1 Pen containing Insulin Glargine Injection 100 IU/ml 1 ML 217.74 244.13 then they may further make corresponding increase in MRP (excluding GST) upto the level of WPI @12.1218% with effect from 1st April, 2023 not exceeding ceiling prices as specified in column (6) in the above table.

(c) All the existing manufacturers of above-mentioned scheduled formulations having MRPlower than the ceiling price specified in column (5) in the above table plus GST as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013 and they may further make corresponding increase in MRP upto the level of WPI @12.1218% with effect from 1st April, 2023.

(d) The manufacturers may add goods and services tax only if they have paid actually or if it is payable to the Government on the ceiling price mentioned in column (6) of the above said table.

(e) Information about the revision, if carried out, shall be forwarded to the Government in either electronic or physical form in Form-II within a period of fifteen days of such revision and non-submission of information under this sub-paragraph shall be construed as non revision of maximum retail price (MRP) and the concerned manufacturer shall be liable to deposit the amount charged over and above the prerevised maximum retail price (MRP), alongwith interest thereon from the date of overcharging.

(f) The ceiling price for a pack of the scheduled formulation shall be arrived at by the concerned manufacturer in accordance with the ceiling price specified in column (6) of the above table as per provisions contained in paragraph 11 of the Drugs (Prices Control) Order, 2013. The manufacturer shall issue a price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS and submit a copy to State Drug Controller and dealers.

(g) As per para 24(4) of DPCO 2013, every retailer and dealer shall display price list and the supplementary price list, if any, as furnished by the manufacturer, on a conspicuous part of the premises where he carries on business in a manner so as to be easily accessible to any person wishing to consult the same.

(h) Where an existing manufacturer of scheduled formulation with dosage or strength orboth as specified in the above table launches a new drug as per paragraph 2(1)(u) of the DPCO, 2013 such existing manufacturer shall apply for prior price approval of such new drug to the NPPA in Form I as specified under Schedule-II of the DPCO, 2013.

(i) The manufacturers of above said scheduled formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any manufacturer intending to discontinue production of above said scheduled formulation shall furnish information to the NPPA, in respect of discontinuation of production and / or import of scheduled formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.

(j) The manufacturers not complying with the ceiling price and notes specified hereinabove shall be liable to deposit the overcharged amount along with interest thereon under the provisions of the Drugs (Prices Control) Order, 2013 read with Essential Commodities Act, 1955.

(k) Consequent to the issue of ceiling price of such formulation as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued prior to the above said date of notification, stand(s) superseded.