MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 14th February, 2017
S.O. 442(E).—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 prices as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any, in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
| SR. No. | Name of the Scheduled Formulation |
Strength | Unit | Ceiling Price (Rs.) |
| (1) | (2) | (3) | (4) | (5) |
| 1. | Hydrochlorothiazide Tablet | Hydrochlorothiazide-50mg | 1 Tablet | 0.07679 |
| 2. | Zolpidem Capsule | Zolpidem-5mg | 1 Capsule | 6.83 |
| 3. | Phenytoin Oral Liquid | Phenytoin-30mg /5ml | 1 ML | 0.27 |
Note :
(a) 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 local taxes 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 local taxes 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 local taxes 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 local taxes 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.
[PN/173/4 1/20 17/F/F. No. 8(41)/20 17/D.P./NPPA-Div.-II]
BALJIT SINGH, Assistant Director
ORDER
New Delhi, the 14th February, 2017
S.O. 443(E).— 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 Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 644(E), dated 2nd March, 2016, 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, hereby fixes the price as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any in respect of the Scheduled formulations specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
| Sr. No. | Name of the Scheduled Formulation | Strength | Unit | Ceiling Price (Rs.) |
| (1) | (2) | (3) | (4) | (5) |
| 1. | Cefotaxime Powder for Injection | Cefotaxime-500mg | Each Pack | 19.04 |
| 2. | Cefotaxime Powder for Injection | Cefotaxime-250mg | Each Pack | 14.47 |
| 3. | Chloroquine Oral liquid | Chloroquine-50mg/5ml | 1 ML | 0.26 |
| 4. | Chloroquine Tablet | Chloroquine-150mg | 1 Tablet | 0.59 |
| 5. | Acetylsalicylic Acid Tablet | Acetylsalicylic Acid-75mg | 1 Tablet | 0.28 |
| 6. | Isosorbide-5-mononitrate Tablet | Isosorbide-5-mononitrate-10mg | 1 Tablet | 1.82 |
| 7. | Isosorbide-5-mononitrate Tablet | Isosorbide-5-mononitrate-20mg | 1 Tablet | 2.84 |
| 8. | Lignocaine Injection | Lignocaine-2% (Preservative free for IV use) | 1 ML | 0.90 |
| 9. | Water for Injection | Water for Injection | Each Pack (5ml) |
2.09 |
| 10. | Water for Injection | Water for Injection | Each Pack (10ml) |
2.17 |
| 11. | Ciprofloxacin Drops | Ciprofloxacin-0.3% | 1 ML | 1.41 |
| 12. | Povidone Iodine Solution | Povidone Iodine-10% | 1 Tablet | 0.66 |
| 13. | Co-trimoxazole [Sulphamethoxazole + Trimethoprim] Tablet | Co-trimoxazole [Sulphamethoxazole + Trimethoprim]-400mg+80mg | 1 Tablet | 0.48 |
| 14. | Co-trimoxazole [Sulphamethoxazole + Trimethoprim] Oral Liquid | Co-trimoxazole
[Sulphamethoxazole+ Trimethoprim]-200mg+40mg/5ml |
1 ML | 0.20 |
| 15. | Co-trimoxazole [Sulphamethoxazole + Trimethoprim] Tablet | Co-trimoxazole [Sulphamethoxazole + Trimethoprim]-800mg+160mg | 1 Tablet | 0.98 |
| 16. | Adenosine Injection | Adenosine-3mg/ml | 1 ML | 82.75 |
| 17. | Clomiphene Tablet | Clomiphene-100mg | 1 Tablet | 10.86 |
| 18. | Clomiphene Tablet | Clomiphene-50mg | 1 Tablet | 6.91 |
| 19. | Isoflurane Inhalation | Isoflurane | 1 ML | 9.30 |
| 20. | Gemcitabine Powder for Injection | Gemcitabine-200mg | Each Pack | 1069.33 |
| 21. | Cytosine arabinoside Powder for Injection | Cytosine arabinoside-1000mg | Each Pack | 953.51 |
| 22. | Metronidazole Injection | Metronidazole-500mg/100ml | 1 ML | 0.12039 |
| 23. | Ciprofloxacin Injection | Ciprofloxacin-200mg/100ml | 1 ML | 0.15659 |
| 24. | Amiodarone Injection | Amiodarone-50mg/ml | 1 ML | 18.19 |
| 25. | Phenobarbitone Oral Liquid | Phenobarbitone-20mg/5ml | 1 ML | 0.35 |
| 26. | Lignocaine + Adrenaline Injection | Lignocaine-2% + Adrenaline- 1 :200000(5mcg/ml) | 1 ML | 0.85 |
| 27. | Sodium bicarbonate Injection | Sodium bicarbonate-8.4% | 1 ML | 1.20 |
| 28. | Sodium bicarbonate Injection | Sodium bicarbonate-7.5% | 1 ML | 1.29 |
| 29. | Salbutamol Inhalation (MDI/DPI) | Salbutamol-100mcg/dose | Per Dose | 0.37 |
| 30. | Ispaghula Granules/ Husk/ Powder | Ispaghula | 1GM | 0.73 |
Note:
(a) 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 local taxes 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 local taxes 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 local taxes 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 local taxes 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 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 prior to the above said date of notification, stand(s) superseded.
[PN/173/4 1/2017/F/F. No. 8(41)/20 17/D.P./NPPA-Div.-II]
BALJIT SINGH, Assistant Director
ORDER
New Delhi, the 14th February, 2017
S.O. 444(E).— In implementation of directions given in line with review order issued vide letter No. 3 1015/72/2016-PI.I dated 06.10.2016 passed by the Department of Pharmaceuticals and in exercise of the powers conferred by paragraphs 4, 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 Order of the Government of India in the Ministry of Chemicals and Fertilizers (National Pharmaceutical Pricing Authority) No. S.O. 1951(E), dated 2nd June, 2016 regarding formulation pack mentioned in the table at Sl. No. 9 in so far as it relates to formulation pack mentioned in the table below, except in respect of things done or omitted to be done before such supersession, the National Pharmaceutical Pricing Authority, hereby fixes the price as specified in column (5) of the table herein below as ceiling price exclusive of local tax applicable, if any in respect of the Scheduled formulation specified in the corresponding entry in column (2) of the said Table with the strength and unit specified respectively in the corresponding entries in columns (3) and (4) thereof:
TABLE
| Sr. No. | Name of the Scheduled Formulation |
Strength | Unit | Ceiling Price (Rs.) |
| (1) | (2) | (3) | (4) | (5) |
| 1. | Propranolol Tablet | Propranolol-40mg | 1 Tablet | 2.56 |
Note :
(a) 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 local taxes 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 local taxes 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 local taxes 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 local taxes 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-IY 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 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 prior to the above said date of notification, stand(s) superseded.
[PN/173/4 1/2017/F/F. No. 8(41)/20 17/D.P./NPPA-Div.-II]
BALJIT SINGH, Assistant Director
ORDER
New Delhi, the 14th February, 2017
S.O. 445(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. 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 (6) of the table herein below as the retail price, exclusive of local taxes, 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 respectively, as specified in the corresponding entries in columns (3), (4) and (5) thereof;
TABLE
| Sr. No. | Name of the Scheduled Formulation / Brand Name |
Strength | Unit | Manufacturer & Marketing Company respectively |
Retail Price (Rs.) |
| (1) | (2) | (3) | (4) | (5) | (6) |
| 1. | Cyblex M 30 XR tablet | Each uncoated bilayered tablet contains:
Metformin HCL 500mg (as extended release) Gliclazide 30mg |
10 Tablets |
M/s Eris Life Sciences Pvt. Ltd. | 49.60 |
| 2. | Cyblex M 40 tablet | Each uncoated tablet contains:
Gliclazide 40mg Metformin HCl 500mg |
10 Tablets | M/s Eris Life Sciences Pvt. Ltd. | 45.40 |
| 3. | Cyblex M 60 XR tablet | Each uncoated bilayered tablet contains:
Gliclazide 60mg (as extended release) Metformin HCl 500mg (as extended release) |
10 Tablets | M/s Eris Life Sciences Pvt. Ltd. | 79.80 |
| 4. | Cyblex M 80 tablet | Each uncoated tablet contains:
Gliclazide 80mg Metformin HCl 500mg |
10 Tablets | M/s Eris Life Sciences Pvt. Ltd. | 50.93 |
| 5. | Cyblex MV 80.2 (0.2/500/80) tablet | Each uncoated tablet contains:
Metformin HCL 500mg Gliclazide 80mg Voglibose 0.2mg |
10 Tablets | M/s Eris Life Sciences Pvt. Ltd. | 113.70 |
| 6. | Cyblex MV 80.3 (0.3/500/80) tablet | Each uncoated tablet contains:
Metformin HCL 500mg Gliclazide 80mg Voglibose 0.3mg |
10 Tablets | M/s Eris Life Sciences Pvt. Ltd. | 115.80 |
Note:
(a) The manufacturers of above mentioned formulations i.e. “new drug” under paragraph 2(u) of the DPCO, 2013 shall fix the retail price as specified in column (6) of the table hereinabove.
(b) The manufacturers may add local taxes 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 manufacturers 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 manufacturers shall issue price list in Form–V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS.
(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 prices are applicable only to the manufacturer / marketeer as mentioned above for generic / any brand of the same composition / strength of the subject formulations, subject to fulfillment of all the applicable statutory requirements as laid down by the Govt. under relevant statutes/ rules, including manufacturing license permission from the Competent Authority i.e. the Central/State Licensing Authority, as may be applicable, by the concerned manufacturers/marketing companies.
(f) The concerned manufacturers of above said formulations shall furnish quarterly return to the NPPA, in respect of production / import and sale of product in Form-III of Schedule-II of the DPCO, 2013 through Manufacturers, in case intending to discontinue above said formulations, shall furnish information to the NPPA, in respect of discontinuation of the production and / or import of above said formulation in Form-IV of Schedule-II of the DPCO, 2013 at least six months prior to the intended date of discontinuation.
(g) 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.
(h) Consequent to the issue of retail price of the aforesaid formulations as specified in column (2) of the above mentioned table in this notification, the price order(s) if any, issued for concerned manufacturer / marketer prior to the above said date of notification, stand(s) superseded.
[PN/173/4 1/2017/F/F. No. 8(41)/20 17/D.P./NPPA-Div.-II]
BALJIT SINGH, Assistant Director
