These include formulations like Praziquantel, Sodium nitrite, Tacrolimus, TD Vaccine.
This came in 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. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, and in supersession of the item specified at Sl. No. 11 & 13 of the Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) S.O. 1214(E), dated 25th March 2020, in so far as it relates to formulation packs mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the prices as specified in column (5) 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. | Name of the Scheduled Formulation | Dosage form & Strength | Unit | Ceiling Price (Rs.) |
(1) | (2) | (3) | (4) | (5) |
1. | Praziquantel | Tablet 600 mg | Per tablet | 34.63 |
2. | Sodium nitrite | Injection 30 mg/ml | Per ml | 25.91 |
The notification in this regard added;
(a) All manufacturers of scheduled formulation, selling the branded or generic or both the versions of scheduled formulation 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 formulation downward not exceeding the ceiling price specified in column (5) in the above table plus goods and services tax as applicable, if any.
(b) All the existing manufacturers of above mentioned scheduled formulation having MRP lower than the ceiling price specified in column (5) 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.
(c) 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 (5) of the above said table.
(d) 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 (5) 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.
(e) 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.
(f) 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 (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.
(g) The manufacturers of above said scheduled formulation shall furnish quarterly return to the NPPA, in respect of production / import and sale of scheduled formulation 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.
(h) 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.
(i) 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.
Meanwhile, ceiling prices of another 6 formulations were fixed in 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. 701(E) dated 10th March, 2016 issued by the Government of India in the Ministry of Chemicals and Fertilizers, the National Pharmaceutical Pricing Authority (hereinafter referred as NPPA) hereby fixes the price as specified in column (5) 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. | Name of the Scheduled Formulation | Dosage form & Strength | Unit | Ceiling Price (Rs.) |
(1) | (2) | (3) | (4) | (5) |
1. | TD Vaccine | Each dose of 0.5ml contains: Diphtheria Toxoid ≤5Lf (≥ 2IU) Tetanus Toxoid ≥ 5Lf (≥ 40IU) | Each 0.5ml Pack | 18.69 |
2. | TD Vaccine | Each dose of 0.5ml contains: Diphtheria Toxoid ≤5Lf (≥ 2IU) Tetanus Toxoid ≥ 5Lf (≥ 40IU) | Each 5ml Pack | 175.59 |
3. | TD Vaccine | Each dose of 0.5ml contains: Diphtheria Toxoid ≤25Lf (≥ 30IU) Tetanus Toxoid ≥ 5Lf (≥ 40IU) | Each 0.5ml Pack | 16.02 |
4. | Tacrolimus | Tablet 0.5 mg | 1 Tablet | 18.68 |
5. | Tacrolimus | Tablet 1 mg | 1 Tablet | 34.31 |
6. | Tacrolimus | Tablet 2 mg | 1 Tablet | 67.77 |
NPPA further clarified;
(a) 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.
(b) All the existing manufacturers of above mentioned scheduled formulations having MRP lower than the ceiling price specified in column (5) 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.
(c) 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 (5) of the above said table.
(d) 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 (5) 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.
(e) 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.
(f) 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 (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.
(g) 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.
(h) 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.
(i) 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.
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