Executive Summary:
This document, issued by the National Pharmaceutical Pricing Authority, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, concerns the price regulation of certain scheduled drug formulations. It fixes ceiling prices for specified formulations and retail prices for others, superseding previous orders. The order is effective as of May 11, 2017, and requires manufacturers to comply with the new pricing and reporting requirements.
Key Points / Main Content:
Ceiling Price Fixation:
* Ceiling prices are fixed for scheduled formulations as specified in the tables, exclusive of local taxes.
* Manufacturers selling above the ceiling price plus local taxes must revise prices downward.
* Manufacturers with existing MRP lower than the ceiling price plus local taxes shall maintain the existing MRP.
* Ceiling price for a pack shall be determined as per paragraph 11 of the Drugs Prices Control Order (DPCO), 2013.
Retail Price Fixation:
* Retail prices are fixed for specific formulations, exclusive of local taxes, as specified in the table.
* The retail price is applicable only to manufacturers/marketers who applied for price fixation/revision by submitting Form I.
General Compliance:
* Manufacturers must issue a price list in Form V to NPPA through IPDMS, and submit a copy to State Drug Controller and dealers.
* Retailers and dealers must display the price list and supplementary price list conspicuously.
* Manufacturers launching new drugs must apply for prior price approval to the NPPA in Form I.
* Manufacturers must furnish quarterly returns in Form III and provide information on discontinuation of production/import in Form IV to the NPPA.
* Non-compliance with ceiling/retail prices will result in liability to deposit the overcharged amount with interest.
* Previous price orders that conflict with this notification are superseded.
Impact Analysis:
Manufacturers:
* Impact: Manufacturers are required to adhere to the fixed ceiling and retail prices, revise existing prices if necessary, and comply with reporting requirements.
* Action Required: Revise prices, issue price lists, submit quarterly returns, and apply for price approval for new drugs.
Retailers and Dealers:
* Impact: Retailers and dealers must display the updated price lists and ensure they sell formulations at or below the ceiling/retail price.
* Action Required: Display price lists and supplementary price lists conspicuously.
National Pharmaceutical Pricing Authority (NPPA):
* Impact: Responsible for enforcing the order, monitoring compliance, and processing price approvals.
* Action Required: Monitor price compliance, review quarterly returns, and process applications for price approvals.
Key Entities Referenced
Ministry of Chemicals and Fertilizers: The government ministry responsible for the Department of Pharmaceuticals and the National Pharmaceutical Pricing Authority.
Department of Pharmaceuticals: A department within the Ministry of Chemicals and Fertilizers that issues review orders related to drug pricing.
National Pharmaceutical Pricing Authority (NPPA): The regulatory body responsible for fixing and revising drug prices in India, ensuring availability and affordability.
Drugs Prices Control Order, 2013 (DPCO, 2013): A legal framework that empowers the NPPA to regulate the prices of essential medicines.
Essential Commodities Act, 1955: An act to provide, in the interests of the general public, for the control of the production, supply and distribution of, and trade and commerce in, certain commodities.
New Delhi: The location where the orders were issued by the Department of Pharmaceuticals.
Dicyclomine Injection: A scheduled formulation whose ceiling price is being fixed by the NPPA.
Erythromycin Estolate Tablet: A scheduled formulation whose ceiling price is being fixed by the NPPA.
REGD. NO. D. L.-33004/99
EXTRAORDINARY
II— — (ii)
PART II—Section 3—Sub-section (ii)
PUBLISHED BY AUTHORITY
1348]
No. 1348] NEW DELHI, THURSDAY, MAY 11, 2017/VAISAKHA 21, 1939
ubZ fnYyh] 11 ebZ] 2017
I
4, 10, 11,
14, 16,
( ) ( )
( )
(1) (2) (3) (4) (5)
1. 3.01
2. 1.95
3098GI/2017 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
(5)
(2)
(5)
V
(4)
II I
II III
II IV
[ / -II]
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
NATIONAL PHARMACEUTICAL PRICING AUTHORITY
ORDER
New Delhi, the 11th May, 2017
S.O. 1525(E).—In implementation of directions given in line with review orders issued by the Department of
Pharmaceuticals (DOP) vide letters no. 31015/99/2016-PI.I dated 05.04.2017 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 issuedII (ii) 3
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.
3431(E), dated 10th November, 2016 at (Sl. No. 17) & S.O. 1039(E) dated 1st April, 2017 at (Sl. No. 208) regarding
formulation packs mentioned in the table 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 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:
TABLE
Sl. No. Name of the Scheduled Dosage form & Strength Unit Ceiling Price
Formulation
(Rs.)
(1) (2) (3) (4) (5)
1. Dicyclomine Injection 10 mg/ml 1 ML 3.01
(1ML & 2 ML Pack)
2. Dicyclomine Injection 10 mg/ml 1 ML 1.95
(10ML & 30 ML Pack)
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/177/45/2017/F/F. No. 8(45)/2017/D.P./NPPA-Div.-II]
BALJIT SINGH, Astt. Director4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
ubZ fnYyh] 11 ebZ] 2017
I
,
4, 10, 11, 14, 16,
( )
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(1) (2) (3) (4) (5)
1. 1 3.02
2. 1 5.86
3. 1 0.53
4. 1 1.31
(5)
(2)
(5)
V
(4)II (ii) 5
II
I
II III
II IV
[ / -II]
ORDER
New Delhi, the 11th May, 2017
S.O. 1526(E).—In implementation of directions given in line with review orders issued by the Department of
Pharmaceuticals (DOP) vide letters no. 31015/20/2015-PI.I dated 30.08.2016 (Erythromycin Estolate Tablet 250mg &
500mg, Erythromycin Estolate Syrup 125mg/5ml & Chloroquine Phosphate Injection 40mg/ml) passed by the
Department of Pharmaceuticals under para 31 of Drugs (Prices Control) Order, 2013 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. 834(E) dated 25th March, 2015 at (Sl. No. 4, 5, 3 & 1)
& No. S.O. 644(E) dated 2nd March, 2016 at (Sl. No. 205, 206, 204 & 115) (Erythromycin Estolate Tablet 250mg &
500mg, Erythromycin Estolate Syrup 125mg/5ml & Chloroquine Phosphate Injection 40mg/ml) regarding formulation
packs mentioned in the table 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 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:
TABLE
Sl. No. Name of the Formulation Dosage form & Strength Unit Ceiling Price
(Rs.)
(1) (2) (3) (4) (5)
1 Erythromycin Estolate Tablet 250mg 1 Tablet 3.02
2 Erythromycin Estolate Tablet 500mg 1 Tablet 5.86
3 Erythromycin Estolate Syrup 125 mg/5 ml 1 ML 0.53
4 Chloroquine Phosphate Injection 40 mg/ml 1 ML 1.31
(64.5mg eq. to 40mg
chloroquine)6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
Note:
(a) All manufacturers of formulations, selling the branded or generic or both the versions of 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 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 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 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 formulations shall furnish quarterly return to the NPPA, in respect of
production/import and sale of formulations in Form-III of Schedule-II of the DPCO, 2013 through IPDMS. Any
manufacturer intending to discontinue production of above said formulation shall furnish information to the NPPA,
in respect of discontinuation of production and/or import of 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/177/45/2017/F/F. No. 8(45)/2017/D.P./NPPA-Div.-II]
BALJIT SINGH, Astt. Director
ubZ fnYyh] 11 ebZ] 2017
,II (ii) 7
(1) (2) (3) (4) (5) (6)
1. 8.00
40
(
) 75
(6)
V
(4)
I
II III
II IV
[ / -II]8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
ORDER
New Delhi, the 11th May, 2017
S.O. 1527(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. Name of the Scheduled Strength Unit Manufacturer & Marketing Retail
No. Formulation/Brand Company respectively Price
Name (Rs.)
(1) (2) (3) (4) (5) (6)
1. P-PPi-L capsules Each hard gelatin capsule 1 Capsule M/s Akums Drugs & 8.00
contains: Pharmaceuticals Ltd./ M/s Blue
Cross Lab. Pvt. Ltd.
Pantoprazole sodium eq. to
Pantoprazole 40mg (as gastro
resistant tablet)
Levosulpiride 75mg (as
uncoated sustained release
tablet)
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 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 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.
(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 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.
(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.II (ii) 9
(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/176/44/2017/F/F. No. 8(44)/2017/D.P./NPPA-Div.-II]
BALJIT SINGH, Astt. 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.