Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-03012024-251106
EXTRAORDINARY
PART II-Section 3-Sub-section (ii)
PUBLISHED BY AUTHORITY
No. 15]
NEW DELHI, MONDAY, JANUARY 1, 2024/PAUSHA 11, 1945
16 GI/2024
[PN/251/119/2023/F/F. No. 8(119)/2023/D.P./NPPA-Div.-II]
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 1st January, 2024
S.O. 15(E). In exercise of the powers conferred by paragraphs 5, 11 and 15 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, the National Pharmaceutical Pricing
Authority (hereinafter referred as NPPA), hereby fixes, the price as specified in column (6) of the table herein below
as the retail price, exclusive of Goods and Services Tax, if any, in relation to the formulation specified in the
corresponding entry in column (2) of the said Table with the strength, unit and name of manufacturer & marketing
company, as specified in the corresponding entries in columns (3), (4) and (5) thereof;
TABLE
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| SI. | Name of the | Strength | Unit | Manufacturer & | Retail Price |
| No. | Formulation / Brand | | | Marketing Company | (Rs.) |
| | Name | | | | |
+=====+===================================+==============================================================================================================================================================================================================================================================================================+================+=============================================================+================+
| (1) | (2) | (3) | (4) | (5) | (6) |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 1 | Bisoprolol Fumarate & | Each film coated tablet contains: | 1 Tablet | M/s Swiss Garnier | 6.74 |
| | Amlodipine tablet | Bisoprolol Fumarate IP 2.5mg | | Biotech Private Limited / | |
| | | Amlodipine Besylate IP Eq. to | | M/s Zydus Healthcare | |
| | | Amlodipine 5mg | | Limited | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 2 | Aceclofenac + | Each film coated tablet contains: | 1 Tablet | M/s Akums Drugs & | 8.00 |
| | Paracetamol + | Aceclofenac IP 100mg, | | Pharmaceuticals Ltd. | |
| | Serratiopeptidase Tablet | Paracetamol IP 325mg | | /M/s Apex Laboratories | |
| | | Serratiopeptidase IP 15mg (As enteric | | Private Limited | |
| | | coated granules eq. to 30000 enzyme | | | |
| | | activity unity of serratiopeptidase) | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 3 | Povidone Iodine Gargle | Composition: | 1 ml | M/s Stedman | 1.93 |
| | | Povidone Iodine Gargle | | Pharmaceuticals Pvt. Ltd. | |
| | | Povidone-Iodine IP 2% w/v (Available | | | |
| | | Iodine 0.2w/v) | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 4 | Amoxycillin + | Each film coated tablet contains: | 1 Tablet | M/s Theon | 40.03 |
| | Potassium Clavulanate Tablets IP | Amoxycillin Trihydrate IP eq. to | | Pharmaceuticals Ltd. / | |
| | | Amoxycillin 875mg | | M/s J.B. Chemicals & | |
| | | Potassium Clavulanate Diluted IP eq. to | | Pharmaceuticals Ltd. | |
| | | Clavulanic Acid 125mg | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 5 | Bilastine and Montelukast Tablets | Each film coated tablet contains: | 1 Tablet | M/s Ravenbhel | 13.02 |
| | | Montelukast Sodium IP Eq. to | | Healthcare Pvt. Ltd. / M/s | |
| | | Montelukast 10mg | | Cadila Pharmaceuticals | |
| | | Bilastine 20mg | | Ltd. | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 6 | Telmisartan and | Each film coated bilayered tablet | 1 Tablet | M/s Pure and Cure | 13.39 |
| | Metoprolol Succinate (ER) Tablet | contains: | | Healthcare Pvt. Ltd. / M/s | |
| | | Telmisartan IP 40mg | | La Renon Healthcare Pvt. | |
| | | Metoprolol Succinate IP 47.50mg eq. to | | Ltd. | |
| | | Metoprolol Tartrate 50mg (as extended | | | |
| | | release form) | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 7 | Metoprolol Succinate | Each film coated bilayered tablet | 1 Tablet | M/s Pure and Cure | 9.12 |
| | Extended Release & | contains:Metoprolol Succinate IP | | Healthcare Pvt. Ltd. / M/s | |
| | Cilnidipine Tablet | 23.75mg eq. to Metoprolol Tartrate IP | | Cipla Limited | |
| | | 25mg (As Extended release form) | | | |
| | | Cilnidipine IP 10mg | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 8 | Metoprolol Succinate | Each film coated bilayered tablet | 1 Tablet | M/s Pure and Cure | 10.21 |
| | Extended Release & | contains: | | Healthcare Pvt. Ltd. / M/s | |
| | Cilnidipine Tablet | Metoprolol Succinate IP 47.50mg eq. to | | Cipla Limited | |
| | | Metoprolol Tartrate 50mg (As Extended | | | |
| | | release form) | | | |
| | | Cilnidipine IP 10mg | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 9 | Trastuzumab 150mg | Combipack of Each pack contains: | 1 Vial | M/s Hetero Biopharma | 15817.49 |
| | | Vial-1 | | Limited/M/s Mankind | |
| | | Lyophilized Powder for concentrate for | | Pharma Limited | |
| | | solution for Intravenous Infusion, Multi | | | |
| | | use vial | | | |
| | | Composition: | | | |
| | | Trastuzumab (r-DNA Origin) IH | | | |
| | | (Active ingredient) 150mg, | | | |
| | | α,α-Trehalose Dihydrate USP (as | | | |
| | | Lyoprotectant) 136.2mg | | | |
| | | L-Histidine Hydrochloride | | | |
| | | Monohydrate EP (as buffering agent) | | | |
| | | 3.36mg | | | |
| | | L-Histidine USP (as buffering agent) | | | |
| | | 2.16mg | | | |
| | | Polysorbate 20 IP (as surfactant) 0.6mg | | | |
| | | Vial -2 | | | |
| | | Bacteriostatic Water for Injection 10 ml | | | |
| | | Single use vial | | | |
| | | Composition: | | | |
| | | Benzyl Alcohol IP 1.1% V/V Water for | | | |
| | | Injection | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 10 | Sucralfate, | Composition:Sucralfate IP 7.0% | Per Gram | M/s Stedman | 4.45 |
| | Metronidazole and | w/wMetronidazole IP 1.0% w/w | | Pharmaceuticals Pvt. Ltd. | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| | Lignocaine | Lignocaine Hydrochloride IP 4.0% | | | |
| | Hydrochloride Cream | w/wCream base q.s. | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 11 | Bisoprolol Fumarate | Each film coated tablet contains: | 1 Tablet | M/s Ravenbhel | 9.73 |
| | and Telmisartan Tablets | Bisoprolol Fumarate IP 2.5 mg | | Healthcare Pvt. Ltd. / M/s | |
| | | Telmisartan IP 40 mg | | La Renon Healthcare Pvt. | |
| | | | | Ltd. | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 12 | Bisoprolol Fumarate | Each film coated tablet contains: | 1 Tablet | M/s Ravenbhel | 11.22 |
| | and Telmisartan Tablets | Bisoprolol Fumarate IP 5 mg | | Healthcare Pvt. Ltd. / M/s | |
| | | Telmisartan IP 40 mg | | La Renon Healthcare Pvt. | |
| | | | | Ltd. | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 13 | Bisoprolol Fumarate | Each film coated bilayered tablet | 1 Tablet | M/s Mascot Health Series | 9.73 |
| | and Telmisartan Tablets | contains: | | Pvt. Ltd. / M/s Zydus | |
| | | Bisoprolol Fumarate IP 2.5 mg | | Healthcare Ltd. | |
| | | Telmisartan IP 40 mg | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 14 | Bisoprolol Fumarate | Each film coated bilayered tablet | 1 Tablet | M/s Mascot Health Series | 11.22 |
| | and Telmisartan Tablets | contains: | | Pvt. Ltd. / M/s Zydus | |
| | | Bisoprolol Fumarate IP 5 mg | | Healthcare Ltd. | |
| | | Telmisartan IP 40 mg | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 15 | Norethisterone Acetate | Each Film Coated Controlled Release | 1 Tablet | M/s Akums Drugs & | 15.80 |
| | Controlled Release Tablet | tablet contains: | | Pharmaceuticals Ltd. / | |
| | | Norethisterone Acetate BP 10mg | | M/s Group | |
| | | | | Pharmaceuticals Ltd. | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 16 | Sodium Alginate, | Each 5 ml contains: | 1 ml | M/s Skymap | 0.90 |
| | Sodium Bicarbonate & | Sodium Alginate IP 250mg | | Pharmaceuticals Pvt. Ltd. | |
| | Calcium Carbonate Oral Suspension | Sodium Bicarbonate IP 133.5mg | | | |
| | | Calcium Carbonate IP 80mg | | | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 17 | Sodium Alginate, | Each 5 ml contains: | 1 ml | M/s Skymap | 0.90 |
| | Sodium Bicarbonate & | Sodium Alginate IP 250mg | | Pharmaceuticals Pvt. Ltd. | |
| | Calcium Carbonate Oral Suspension | Sodium Bicarbonate IP 133.5mg | | / M/s Glensmith Labs | |
| | | Calcium Carbonate IP 80mg | | Pvt. Ltd. | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 18 | Sodium Alginate, | Each 5 ml contains: | 1 ml | M/s Skymap | 0.90 |
| | Sodium Bicarbonate & | Sodium Alginate IP 250mg | | Pharmaceuticals Pvt. Ltd. | |
| | Calcium Carbonate Oral Suspension | Sodium Bicarbonate IP 133.5mg | | / M/s Jagsonpal | |
| | | Calcium Carbonate IP 80mg | | Pharmaceuticals Ltd. | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
| 19 | Albendazole & | Each uncoated chewable tablet | 1 Tablet | M/s IBN Herbals (A unit | 24.63 |
| | Ivermectin Tablets | contains: | | of Curetech Formulation | |
| | | Albendazole IP 400mg | | (P) Ltd.) / M/s Indoco | |
| | | Ivermectin IP 6mg | | Remedies Limited | |
+-----+-----------------------------------+----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+----------------+-------------------------------------------------------------+----------------+
Note:
(a) The manufacturer of above-mentioned formulations i.e., "new drug" under paragraph 2(1)(u) of the DPCO,
2013 shall fix the retail price as specified in column (6) of the table hereinabove.
(b) The manufacturer may add Goods and Services Tax only if they have paid actually or it is payable to the
Government on the retail price mentioned in column (6) of the above said table.
(c) The retail price for a pack of the aforesaid formulation shall be arrived at by the concerned manufacturer in
accordance with the retail price specified in column (6) of the above table as per provisions contained in
paragraph 11 of the DPCO, 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.
(d) 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.
(e) The above mentioned retail price is applicable only to the individual manufacturer / marketer as mentioned
above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated
(f) In case the retail price of any of the aforesaid formulations is not complied with, as per instant price
notification and notes specified hereinabove, then the concerned manufacturer/marketing company shall be
liable to deposit the overcharged amount along with the interest thereon under the provisions of the DPCO,
2013 read with the Essential Commodities Act, 1955.
(g) Consequent to the fixation of retail price of such formulation as specified in column (2) of the above table
with the strength and name of Manufacturer & Marketing Companies specified in the corresponding entries
in Column (3) & (5) thereof, the price order(s) fixing the retail price of the formulation with specified
strength for that Manufacturer & Marketing Companies as specified in corresponding entries in Column (2),
(3) and (5) thereof, if any, issued prior to this notification, stand(s) superseded.
[PN/251/119/2023/F/F. No. 8(119)/2023/D.P./NPPA-Div.-II]
MAHAVEER SAINI, Dy. Director (Pricing)
CORRIGENDUM
New Delhi, the 1st January, 2024
S.O. 16(E).—In the National Pharmaceutical Pricing Authority's notification S.O. 5937(E), dated
19th December, 2022 relating to fixation of retail price, published in the Gazette of India, Extraordinary, the Entry at
Sl. No. 4 of the Table, both in Hindi & English version shall henceforth,
Instead of
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-----------------------------------+----------------+
| SI. | Name of the | Strength | Unit | Manufacturer & | Retail Price |
| No. | Formulation / Brand | | | Marketing Company | (Rs.) |
| | Name | | | | |
+=====+===================================+==========================================================================================================================================================================================+============+===================================+================+
| (1) | (2) | (3) | (4) | (5) | (6) |
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-----------------------------------+----------------+
| 4 | Ceftazidime and | Each vial contains: | Per Vial | M/s Cipla Limited | 2500.00 |
| | Avibactam powder for | Ceftazidime (pentahydrate) IP eq. to | | | |
| | concentrate for | Ceftazidime 2gm | | | |
| | solution for infusion | Avibactam Sodium eq. to Avibactam | | | |
| | | 0.5gm | | | |
| | | Sodium content approx. 148mg | | | |
| | | (6.4meq)/vial | | | |
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-----------------------------------+----------------+
To be read as follows:
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-----------------------------------+----------------+
| SI. | Name of the | Strength | Unit | Manufacturer & | Retail Price |
| No. | Formulation / Brand | | | Marketing Company | (Rs.) |
| | Name | | | | |
+=====+===================================+==========================================================================================================================================================================================+============+===================================+================+
| (1) | (2) | (3) | (4) | (5) | (6) |
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-----------------------------------+----------------+
| 4 | Ceftazidime and | Each vial contains: | Per Vial | M/s Cipla Limited | 1886.66 |
| | Avibactam powder for | Ceftazidime (pentahydrate) IP eq. to | | | |
| | concentrate for | Ceftazidime 2gm | | | |
| | solution for infusion | Avibactam Sodium eq. to Avibactam | | | |
| | | 0.5gm | | | |
| | | Sodium content approx. 148mg | | | |
| | | (6.4meq)/vial | | | |
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-----------------------------------+----------------+
All the notes and other contents mentioned in the original order S.O. 5937(E), dated 19th December, 2022
shall remain the same
[PN/251/119/2023/F/F. No. 8(119)/2023/D.P./NPPA-Div.-II]
MAHAVEER SAINI, Dy. Director
CORRIGENDUM
New Delhi, the 1st January, 2024
S.O. 17(E).—In the National Pharmaceutical Pricing Authority's notification S.O. 1434(E), dated
27th March, 2023 relating to fixation of retail price, published in the Gazette of India, Extraordinary, the Entry at
Sl. No. 23 of the Table, both in Hindi & English version shall henceforth,
Instead of
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-------------------------------------------------------------+----------------+
| SI. | Name of the | Strength | Unit | Manufacturer & | Retail Price |
| No. | Formulation / Brand | | | Marketing Company | (Rs.) |
| | Name | | | | |
+=====+===================================+==========================================================================================================================================================================================+============+=============================================================+================+
| (1) | (2) | (3) | (4) | (5) | (6) |
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-------------------------------------------------------------+----------------+
| 23 | Ceftazidime and | Each vial contains: | 1 ml | M/s BDR Pharmaceuticals | 3773.31 |
| | Avibactam powder for | Ceftazidime (as ceftazidime | | International Pvt. Ltd. / | |
| | concentrate for solution | Pentahydrate) IP 2gram | | M/s Wockhardt Limited | |
| | for infusion | Avibactam Sodium eq. to | | | |
| | | Avibactam 0.5gm | | | |
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-------------------------------------------------------------+----------------+
To be read as follows:
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-------------------------------------------------------------+----------------+
| SI. | Name of the | Strength | Unit | Manufacturer & | Retail Price |
| No. | Formulation / Brand | | | Marketing Company | (Rs.) |
| | Name | | | | |
+=====+===================================+==========================================================================================================================================================================================+============+=============================================================+================+
| (1) | (2) | (3) | (4) | (5) | (6) |
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-------------------------------------------------------------+----------------+
| 23 | Ceftazidime and | Each vial contains: | Per Vial | M/s BDR Pharmaceuticals | 1886.66 |
| | Avibactam powder for | Ceftazidime (as ceftazidime | | International Pvt. Ltd. / | |
| | concentrate for | Pentahydrate) IP 2gram | | M/s Wockhardt Limited | |
| | solution for infusion | Avibactam Sodium eq. to Avibactam | | | |
| | | 0.5gm | | | |
+-----+-----------------------------------+------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------+------------+-------------------------------------------------------------+----------------+
All the notes and other contents mentioned in the original order S.O. 1434(E), dated 27th March, 2023 shall
remain the same.
[PN/251/119/2023/F/F. No. 8(119)/2023/D.P./NPPA-Div.-II]
MAHAVEER SAINI, Dy. Director
Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064
and Published by the Controller of Publications, Delhi-110054.
MANOJ Digitally signed by MANOJ KUMAR VERMA KUMAR VERMA Date: 2024.01.03 18:30:46 +0530
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