(Published in Part II, Section 3, Sub Section (ii) of the
Gazette of India Extraordinary)
Government of India
Ministry of Chemicals and Fertilizers
Department of Pharmaceuticals
(National Pharmaceuticals Pricing Authority)
New Delhi, the 17th August, 2016
ORDER
S.O.2732(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
Sl. No. | Name of the Scheduled Formulation / Brand Name | Strength | Unit | Manufacturer & Marketing Company respectively | Retail Price (Rs.) |
---|---|---|---|---|---|
(1) | (2) | (3) | (4) | (5) | (6) |
1 | Amlodipine + Metoprolol Tablet (Starpress-AM XL 25) |
Each uncoated bilayerd tablet contains: Amlodipine Besylate eq. to Amlodipine-5mg Metoprolol Succinate-23.75mg eq. to Metoprolol Tartrate-25mg (as extended release form) |
1 Tablet | M/s Tristar Formulations Pvt. Ltd. & M/s Lupin Ltd. |
4.80 |
2 | Amlodipine + Metoprolol Tablet (Amlodac M25) |
Each uncoated bilayered tablet contains: Amlodipine Besylate eq. to Amlodipine-5mg Metoprolol Succinate-23.75mg eq. to Metoprolol Tartrate-25mg (as extended release) |
1 Tablet | M/s German Remedies Ltd. | 4.80 |
3 | Glimepiride Tablet (Glucoryl 4mg) |
Each film coated tablet contains: Glimepiride-4mg |
1 Tablet | M/s Savi Pharma & M/s Alkem Lab. Ltd. |
6.00 |
4 | r-Hu Erythropoietin (r-HuEPO) Injection (Renocrit 4000) |
Each pre-filled syringe contains: r-Hu Erythropoietin (r-HuEPO)-4000 IU |
Each Pack | M/s Cadila Healthcare Ltd. | 1237.23 |
5 | Zoledronic Acid infusion | Each 100ml contains: Zoledronic Acid-4mg |
Each Pack | M/s Cadila Healthcare Ltd. | 3609.13 |
6 | Doxorubicin HCl Pegylated Liposomal Injection |
Each ml contains: Doxorubicin HCl Pegylated Liposomal-2mg |
1 ml | M/s Emcure Pharmaceuticals Ltd. | 723.93 |
7 | Telmisartan+ Chlorthalidone Tablet |
Each uncoated bilayered tablet contains: Telmisartan-40mg Chlorthalidone-6.25mg |
1 Tablet | M/s Windlas Biotech Ltd. & M/s Emcure Pharmaceuticals Ltd. |
7.73 |
8 | Metformin HCl SR+ Voglibose+ Glimepiride Tablet |
Each uncoated bilayered tablet contains: Metformin HCl-500mg (in sustained release form) Voglibose-0.2mg Glimepiride-2mg |
10 Tablets | M/s Inventia Healthcare Pvt. Ltd. & M/s Jubilant Life Sciences Ltd. |
90.48 |
9 | Metformin HCl SR+ Voglibose+ Glimepiride Tablet |
Each uncoated bilayered tablet contains: Metformin HCl-500mg (in sustained release form) Voglibose-0.2mg Glimepiride-1mg |
10 Tablets | M/s Inventia Healthcare Pvt. Ltd. & M/s Jubilant Life Sciences Ltd. |
71.43 |
10 | Paroxetine HCl+ Clonazepam Capsule (Clonotril P 25mg) |
Each hard gelatin capsule contains: Paroxetine HCl (as Hemihydrate) eq. to Paroxetine-25mg (as enteric coated controlled release tablet) Clonazepam-0.5mg (as immediate release tablet) |
1 Capsule | M/s Torrent Pharmaceuticals Ltd. | 12.50 |
11 | Paroxetine HCl+ Clonazepam Capsule (Clonotril P 12.5mg) |
Each hard gelatin capsule contains: Paroxetine HCl (as Hemihydrate) eq. to Paroxetine-12.5mg (as enteric coated controlled release tablet) Clonazepam-0.5mg (as immediate release tablet) |
1 Capsule | M/s Torrent Pharmaceuticals Ltd. | 10.27 |
12 | Phenylephrine HCl+ Chlorpheniramine Maleate+Paracetamol+ Sodium Citrate+ Menthol Syrup (Sudin Kid +) |
Each 5ml contains: Phenylephrine HCl-5mg Chlorpheniramine Maleate-0.5mg Paracetamol-125mg Sodium Citrate-60mg Menthol-1mg |
1 ml | M/s Enicar Pharmaceuticals Pvt. Ltd. & M/s Group Pharmaceuticals Ltd. |
0.59 |
13 | Phenylephrine HCl+ Chlorpheniramine Maleate+Paracetamol+ Sodium Citrate+ Menthol Syrup (Nablok-New) |
Each 5ml contains: Phenylephrine HCl-5mg Chlorpheniramine Maleate-0.5mg Paracetamol-125mg Sodium Citrate-60mg Menthol-1mg |
1 ml | M/s Pharma Force Lab. & M/s Lifestar Pharma Pvt. Ltd. |
0.59 |
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 a price list in Form-V from date of Notification as per paragraph 24 of the DPCO, 2013 to NPPA through IPDMS.
(d) The above mentioned retail price is applicable only to the individual manufacturers/marketeers as mentioned above i.e. who have applied for the same by submitting Form-I for price fixation / revision as stipulated under DPCO, 2013 and 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.
(e) 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 IPDMS. 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.
(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 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 / marketeer prior to the above said date of notification, stand(s) superseded.
PN/167/35/2016/F
No. 8(35)/2016/D.P./NPPA-Div.II
(BALJIT SINGH)
Assistant Director
National Pharmaceutical Pricing Authority
Last Page Updated: 05-01-2019
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