NPPA revises ceiling price of anti Tuberculosis drug Isoniazid
New Delhi: Through a recent notice, after considering the Wholesale Price Index (WPI) at 0.00551% for the year 2024, the National Pharmaceutical Pricing Authority (NPPA) has revised the ceiling price of the antituberculous drug Isoniazid (INH) under para 31 of the Drugs (Prices Control) Order, 2013.
This matter was discussed in the 123rd Authority meeting dated 10th May 2024, where the expert panel revised the ceiling price of the Isoniazid from Rs 0.65 to Rs 0.73.
"Ceiling Price" refers to a price fixed by the Government for Scheduled Formulations in accordance with the provisions of the drugs (prices control) order, 2013. The ceiling Price is the Maximum Price to the Retailer (excluding Taxes, if any)for the given product.
Isoniazid (INH) is an antibiotic indicated in the first-line treatment of active Mycobacterium tuberculosis (TB) infection. Active TB infection can present as fever, chills, night sweats, cough, hemoptysis, and/or weight loss.
Isoniazid is used with other medications to treat active tuberculosis (TB) infections. It is also used alone to prevent active TB infections in people who may be infected with the bacteria (people with positive TB skin test). Isoniazid is an antibiotic and works by stopping the growth of bacteria. Isoniazid is an antibiotic used to treat mycobacterial infections; most commonly used in combination with other antimycobacterial agents for the treatment of active or latent tuberculosis.
Isoniazid is a prodrug and must be activated by bacterial catalase. Specifically, activation is associated with the reduction of the mycobacterial ferric KatG catalase-peroxidase by hydrazine and reaction with oxygen to form an oxy-ferrous enzyme complex. Once activated, isoniazid inhibits the synthesis of mycolic acids, an essential component of the bacterial cell wall. At therapeutic levels, isoniazid is bacteriocidal against actively growing intracellular and extracellular Mycobacterium tuberculosis organisms. Specifically, isoniazid inhibits InhA, the enoyl reductase from Mycobacterium tuberculosis, by forming a covalent adduct with the NAD cofactor. It is the INH-NAD adduct that acts as a slow, tight-binding competitive inhibitor of InhA.
The notice stated that in the implementation of directions of review order issued by the Department of Pharmaceuticals (DOP) under para 31 of Drugs (Prices Control) Order, 2013 vide order specified in column (7) of the table below and in the exercise of the powers conferred by paragraphs 4, 6, 10, 11, 14, 16, 17 and 18 of the Drugs (Prices Control) Order, 2013, read with S.O. 1394(E) dated the 30th May 2013 and S.O. 5249(E) dated 11th November 2022 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. No. and date specified in Column (8) of the table, the National Pharmaceutical Pricing Authority, has fixed/revised the price including WPI impact @0.00551% for the year 2024 as specified in column (6) of the table herein below as ceiling price exclusive of Goods and Services Tax applicable, if any, in respect of the Scheduled formulation 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:
Sl. No . | Medicine s | Dosage form & Strength | Unit | Ceilin g Price under NLEM, 2022 (Rs.) | Revised Ceiling price based on Review Order & considering WPI @0.00551 % (Rs.) | Review Order number and date | Existing SO number and date |
(1) | (2) | (3) | (4) | (5) | (6) | (7) | (8) |
1. | Isoniazid | Tablet 100 mg | 1 Tablet | 0.65 | 0.73 | 31015/75/2023 -Pricing dated 05.03.2024 | 1547(E) dated 26.03.202 4 (Sl. No. 353) |
The notification further added:
- All manufacturers of scheduled formulations, 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 (6) in the above table plus Goods and Services Tax as applicable, if any.
- All the existing manufacturers of above-mentioned scheduled formulations having MRP lower than the ceiling price specified in column (6) in the above table plus Goods and Services Tax as applicable, if any, shall continue to maintain the existing MRP in accordance with paragraph 13 (2) of the DPCO, 2013.
- 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.
- 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.
- As per para 24(4) of DPCO 2013, every retailer and dealer shall display the 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.
- Where an existing manufacturer of scheduled formulation with dosage or strength or both 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.
- The manufacturers of above said scheduled formulations shall furnish quarterly returns 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 before the intended date of discontinuation.
- 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.
- Consequent to the issue of ceiling prices of such formulations as specified in column (2) of the above table in this notification, the price order(s) fixing ceiling or retail price, if any, issued before the above-said date of notification, stand(s) superseded.
To view this notice click on the below link:
https://medicaldialogues.in/pdf_upload/9483b731bcddceae3ba3e787c7995f21-238780.pdf
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