Executive Summary & Key Takeaways
Executive Summary:
This order issued by the National Pharmaceutical Pricing Authority (NPPA) fixes the retail prices of various scheduled formulations, as specified in the attached table, effective May 31, 2019. It outlines the responsibilities of manufacturers, retailers, and dealers concerning these prices, including the issuance and display of price lists. Previous price orders for the listed formulations are superseded by this notification.
Key Points / Main Content:
* **Price Fixation:**
* Retail prices for specific formulations are fixed as listed in column 6 of the table, exclusive of GST.
* Manufacturers of new drugs under DPCO, 2013, paragraph 2u, must adhere to the retail prices specified.
* **GST Application:**
* Manufacturers may add GST if it is actually paid or payable to the government on the retail price.
* **Retail Price Calculation:**
* Manufacturers must determine the retail price for packs of formulations based on the specified retail price in column 6, following DPCO, 2013, paragraph 11.
* **Price List Issuance:**
* Manufacturers must issue a price list in Form V to the NPPA via IPDMS and provide copies to State Drug Controllers and dealers, as per DPCO, 2013, paragraph 24.
* **Price List Display:**
* Retailers and dealers must display the price list and supplementary list, if any, provided by the manufacturer in a visible location, as per DPCO, 2013, paragraph 24(4).
* **Applicability:**
* The retail prices apply only to the manufacturers/marketers who submitted Form I for price fixation/revision under DPCO, 2013.
* Compliance with statutory requirements, including manufacturing license permissions, is mandatory.
* **Non-Compliance:**
* Manufacturers/marketers failing to comply with the price notification must deposit the overcharged amount with interest under the Essential Commodities Act, 1955, and DPCO, 2013.
* **Supersession:**
* This order supersedes any prior price orders for the formulations listed in column 2 of the table.
Impact Analysis:
* Manufacturers:
* Impact: Required to adhere to the fixed retail prices, issue price lists, and comply with all statutory requirements.
* Action Required: Fix retail prices as specified, issue price lists in Form V, and ensure compliance with DPCO, 2013.
* Retailers and Dealers:
* Impact: Must display price lists and supplementary lists as provided by manufacturers.
* Action Required: Display the manufacturer-provided price lists conspicuously on their premises.
* Consumers:
* Impact: Benefit from regulated retail prices for the specified formulations.
* Action Required: Be aware of the fixed prices and report any discrepancies.
Key Entities Referenced
New Delhi : The capital of India, where the order was issued.
National Pharmaceutical Pricing Authority : A government regulatory agency in India that fixes and revises prices of pharmaceutical products. Referred to as NPPA.
Drugs Prices Control Order, 2013 : A legal order issued by the Government of India to regulate the prices of drugs.
Ministry of Chemicals and Fertilizers : A ministry of the Government of India responsible for the development and regulation of the chemical and fertilizer industries.
Essential Commodities Act, 1955 : An act of the Parliament of India that ensures the supply of essential commodities.
IPDMS : An online system through which manufacturers are required to submit price lists to the NPPA.
State Drug Controller : A regulatory authority at the state level responsible for the control and regulation of drugs.
Goods and Services Tax : An indirect tax levied on the supply of goods and services in India.
See Full Document Text
jftLVªh laö Mhö ,yö&33004@99 REGD. NO. D. L.-33004/99
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EXTRAORDINARY
Hkkx II—[k.M 3—mi&[k.M (ii)
PART II—Section 3—Sub-section (ii)
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PUBLISHED BY AUTHORITY
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No. 1696] NEW DELHI, FRIDAY, MAY 31, 2019/JYAISTHA 10, 1941
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[dka- la- 199@67/2019@,Q@Qk- la- 8¼67½@2019@Mhih@,uihih,&fMoh--II]
izlsuthr nkl] lgk;d funs'kd
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 31st May, 2019
S.O. 1894(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 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
Sl. Name of the Strength Unit Manufacturer & Retail
No. Formulation / Brand Marketing Company Price
Name (Rs.)
(1) (2) (3) (4) (5) (6)
1. Alpha Lipoic + Each soft gelatine capsule contains: M/s Olive Healthcare / 15.66
Methylcobalamin + Alpha Lipoic Acid USP 200 mg, M/s Zydus Healthcare
Inositol USP + Folic Methylcobalamin 1500 mcg, Limited
Acid + Benfotiamine + Inositol USP NF 100 mg, Folic Acid IP 1
Chromium 1.5mg, Benfotiamine 150 mg, Chromium Capsule
Polynicotinate + Polynicotinate 200 mcg, Pyridoxine
Pyridoxine Hydrochloride IP 3 mg
Hydrochloride Capsule
2. Voveran 1ml AQ Each 1ml glass ampoule contains: 21.92
Per 1ml M/s Nitin Life Sciences /
Injection Diclofenac Sodium IP 75mg,
Pack M/s Novartis India Limited
Water for Injection
3. Diclofenac + Each Hard Gelatin capsule contains: 12.61
M/s Akums Drugs &
Thiocolchicoside Diclofenac Sodium IP 50mg (As Enteric 1
Pharmaceuticals Ltd. / M/s
Capsule coated tablet) Capsule
Novartis India Limited
Thiocolchicoside 4mg
4. Diclofenac + Each Hard Gelatin capsule contains: 18.91
M/s Akums Drugs &
Thiocolchicoside Diclofenac Sodium IP 50mg (As Enteric 1
Pharmaceuticals Ltd. / M/s
Capsule coated tablet) Capsule
Novartis India Limited
Thiocolchicoside 8mg
5. Amoxycillin + Each film coated tablet contains: 30.75
M/s Theon
Clavulanic Acid Tablet Amoxycillin Trihydrate IP eq. to
Pharmaceuticals Ltd. / M/s
(UNIMOX CV 1000) Amoxycillin 875mg, 1 Tablet
Macmillon
Potassium Clavulanate Diluted IP eq. to
Pharmaceuticals Limited
Clavulanic Acid 125mg
6. Glimepiride + Each uncoated bilayered tablet contains: 11.80
M/s Theon
Metformin + Voglibose Glimepiride IP 2mg,
Pharmaceuticals Limited /
Tablet Metformin Hydrochloride IP 500mg (As 1 Tablet
M/s Indoco Remedies
Sustained Release form),
Limited
Voglibose IP 0.2mg¹Hkkx IIµ[k.M 3(ii)º Hkkjr dk jkti=k % vlk/kj.k 5
7. Erythropoietin + Each 1.0ml contains: 6490.00
Human Albumin + Erythropoietin Concentrated Solution IP
Sodium Chloride + 40000IU
Sodium Phosphate + Human Albumin IP 2.50mg,
M/s Serum Institute of
Sodium Dihydrogen Sodium Chloride IP 7.80mg, Per Vial
India Pvt. Ltd.
Phosphate Sodium Phosphate IP 2.20mg
Monohydrate Injection Sodium Dihydrogen Phosphate
(Repoitin 40000) Monohydrate B. P. 0.96mg
Water for Injection IP q.s.
8. Amlodipine + Each film coated bilayered Tablet contains: 5.51
Metoprolol Tablet Amlodipine Besilate eq. to Amlodipine M/s Pure & Cure
(Amlosafe MT 25mg) 5mg, Healthcare Pvt. Ltd. / M/s
1 Tablet
Metoprolol Succinate 23.75mg eq. to Aristo Pharmaceuticals
Metoprolol Tartrate 25mg (As Prolonged Pvt. Ltd.
Release)
9. Rabeprazole + Each capsule contains: 8.24
Domperidone Capsule Rabeprazole Sodium IP 20mg (as enteric
1 M/s Inventia Healthcare
(Instek D Capsule) coated pellets),
Capsule Limited
Domperidone IP 30mg (as sustained release
pellets)
10. Pantoprazole + Each hard gelatin capsule contains: 8.007
Domperidone Capsule Pantoprazole Sodium IP (as Pantoprazole
(Domelong P Capsule) Sodium Sesquihydrate) eq. to Pantoprazole 1 M/s Inventia Healthcare
40mg (as Gastro-resistant pellets) Capsule Limited
Domperidone IP 30mg (as Prolonged
release pellets)
11. Metformin + Voglibose Each uncoated bilayered tablet contains: M/s Inventia Healthcare 6.76
Tablet (Proglutrol V Metformin Hydrochloride IP 500mg (in Pvt. Ltd.
1 Tablet
0.2) Sustained release form),
Voglibose IP 0.2mg
12. Metformin + Voglibose Each uncoated bilayered tablet contains: M/s Inventia Healthcare 8.56
Tablet (Proglutrol V Metformin Hydrochloride IP 500mg (in Pvt. Ltd.
1 Tablet
0.3) Sustained release form),
Voglibose IP 0.3mg
13. Metformin + Each uncoated bilayered tablet contains: M/s Inventia Healthcare 5.13
Glimepiride Tablet Metformin Hydrochloride IP 500mg (in Pvt. Ltd.
1 Tablet
(Proglutrol G1) prolonged release form),
Glimepiride IP 1mg
14. Metformin + Each uncoated bilayered tablet contains: M/s Inventia Healthcare 6.76
Glimepiride Tablet Metformin Hydrochloride IP 500mg (in Pvt. Ltd.
1 Tablet
(Proglutrol G2) prolonged release form),
Glimepiride IP 2mg
15. Metformin + Each uncoated bilayered tablet contains: M/s Inventia Healthcare 6.47
Glimepiride Tablet Metformin Hydrochloride IP 1000mg (in Pvt. Ltd.
1 Tablet
(Proglutrol G1 Forte) prolonged release form),
Glimepiride IP 1mg
16. Metformin + Each uncoated bilayered tablet contains: M/s Inventia Healthcare 8.75
Glimepiride Tablet Metformin Hydrochloride IP 1000mg (in Pvt. Ltd.
1 Tablet
(Proglutrol G2 Forte) prolonged release form),
Glimepiride IP 2mg
17. Pantoprazole Sodium + Each hard gelatine capsules contains: M/s Vidhyasha 16.72
Itopride Hydrochloride Pantoprazole Sodium IP eq. to Pantoprazole Pharmaceuticals / M/s
1
Capsules (PANZO-IT) 40mg (as enteric coated pellets), Macmillon
Capsule
Itopride Hydrochloride 150mg (as sustained Pharmaceuticals Limited
release pellets)
18. Atorvastatin Tablet Each film coated tablet contains: 27.54
M/s Unison
(TORVASON -80) Atorvastatin Calcium IP eq. to Atorvastatin 1 Tablet
Pharmaceuticals Pvt. Ltd.
80mg6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
Note:
(a) The manufacturer 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 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 under
DPCO, 2013 and subject to fulfilment 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 manufacturer/marketing companies.
(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 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/199/67/2019/F /F. No. 8(67)/2019/D.P./NPPA-Div.-II]
PRASENJIT DAS, Asst. 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.