Date: 2022-04-18Category: Extra OrdinaryState: Union GovernmentCountry: India
Retail fixation of 15 new drugs and ceiling price fixation of 1 scheduled formulation based on the decision taken in the 96th Authority meeting held on 24.03.2022
Okay, I will analyze the provided government policy text and generate the requested informative report, focusing on the aspects outlined in the instructions and tailoring the content based on whether it seems to represent a new policy or an amendment.
**Report on Pharmaceutical Pricing Policy**
**1. Executive Summary:**
The document provided constitutes a notification from the National Pharmaceutical Pricing Authority (NPPA), likely as an *amendment* or *update* to the existing Drugs Prices Control Order (DPCO) 2013. The core purpose is to fix or revise the retail/ceiling prices of specific pharmaceutical formulations, as detailed in the tables included in the document. The key findings indicate specific price adjustments for various drugs, along with reiteration of compliance requirements for manufacturers and retailers regarding pricing and reporting. This report analyzes the key provisions and implications of this notification.
**2. Introduction:**
This report aims to provide an informative overview and analysis of the NPPA notification dated April 18, 2022, concerning pharmaceutical pricing. The analysis is based solely on the content of the provided text and focuses on understanding the policy's objectives, key provisions, target audience, and potential impact.
**3. Policy Overview:**
* **Amendment to:** Drugs Prices Control Order (DPCO) 2013, read with S.O. 1394E dated the 30th May, 2013 and S. O. 701E dated 10th March, 2016.
* **Core Objective(s):**
* Fixing or revising the retail/ceiling prices of scheduled pharmaceutical formulations.
* Ensuring the availability of essential medicines at regulated prices.
* Enforcing compliance with pricing regulations among manufacturers and retailers.
**4. Background and Rationale:**
The notification appears to be an amendment to the DPCO 2013 to adjust the prices of certain drugs, likely in response to factors such as:
* Changes in input costs for pharmaceutical manufacturing.
* The need to ensure continued availability of essential medicines.
* Periodic review and adjustment of drug prices under the DPCO framework.
* Introduction of new drugs under paragraph 2u of the DPCO, 2013
The inclusion of specific drug formulations and their revised prices suggests a targeted approach to price regulation based on market conditions and the essentiality of the medicines.
**5. Key Provisions / Changes:**
This section details the specific changes introduced by the amendment text:
* **Specific Price Fixation:** The core change is the fixing or revising of retail prices for specific pharmaceutical formulations. This is presented in tabular format, listing the:
* Name of the Formulation.
* Strength and Unit.
* Manufacturer / Marketing Company.
* Retail Price (in Rupees).
* **Example Changes (Based on the Tables):**
* Metformin extended release Teneligliptin: Retail price fixed at Rs. 7.14 per tablet for Ms Associated Biotech/Ms Dales Laboratories
* Dapagliflozin Metformin: Retail price fixed at Rs. 10.70 per tablet for Ms Exemed Pharmaceuticals/Ms Emcure Pharmaceuticals Limited.
* **Compliance Requirements:** The notification reiterates the manufacturers' responsibility to:
* Adhere to the fixed retail prices.
* Issue price lists in Form V to NPPA, State Drug Controllers, and dealers.
* Display price lists conspicuously in their business premises.
* **Clarifications on GST:** Manufacturers are allowed to add Goods and Services Tax (GST) to the retail price only if they have actually paid it or it is payable to the government.
* **New Drug Introduction:** 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 ScheduleII of the DPCO, 2013.
* **Reporting Requirements:** 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 FormIII of ScheduleII of the DPCO, 2013 through IPDMS.
**6. Target Audience and Stakeholders:**
The primary target audience and stakeholders directly affected by this notification include:
* Pharmaceutical manufacturers of the listed formulations.
* Marketing companies associated with these formulations.
* Retailers and distributors of the listed drugs.
* Consumers who purchase these medications.
* State Drug Controllers.
**7. Implementation Aspects (Inferred):**
* **Responsible Agency:** The National Pharmaceutical Pricing Authority (NPPA) is the responsible agency for implementing and enforcing this notification.
* **Timelines:** The notification is effective from the date of issue (April 18, 2022). Manufacturers are expected to adjust their prices and issue revised price lists promptly.
* **Procedures:**
* Manufacturers must submit price lists to the NPPA through the IPDMS (Integrated Pharma Database Management System).
* Retailers must display price lists in their premises.
* Quarterly reports on production, import and sale of scheduled formulations to be submitted by manufacturer in FormIII of ScheduleII of the DPCO, 2013 through IPDMS
* For discontinuation of production and or import of scheduled formulation, manufacturers must furnish information to the NPPA in FormIV of ScheduleII of the DPCO, 2013 at least six months prior to the intended date of discontinuation.
* **Enforcement:** Non-compliance with the pricing regulations may result in penalties, including the deposit of overcharged amounts with interest, as per the DPCO 2013 and the Essential Commodities Act, 1955.
**8. Expected Outcomes / Impact of Changes:**
The intended outcomes of these specific price adjustments and compliance measures likely include:
* Ensuring that the listed essential medicines are available to consumers at regulated and affordable prices.
* Promoting fair competition and preventing profiteering in the pharmaceutical market.
* Improving transparency and accountability in drug pricing.
* Provide opportunity for existing manufacturer to apply for price approval for new drug launched as per paragraph 2 u of the DPCO, 2013.
**9. Conclusion:**
The NPPA notification serves as an important instrument for regulating pharmaceutical prices and ensuring the availability of essential medicines at affordable rates. The detailed price adjustments and compliance requirements outlined in the notification underscore the government's commitment to monitoring and controlling drug prices in the interest of public health. Manufacturers and retailers must comply with these regulations to avoid penalties. The changes represent an active management of drug pricing within the existing regulatory framework of the DPCO 2013.
Key Entities Referenced
NEW DELHI: Location of publication.
APRIL 18, 2022: Date of publication.
Ministry of Chemicals and Fertilizers: The Indian government ministry that issued the notification through the Department of Pharmaceuticals.
Department of Pharmaceuticals: A department under the Ministry of Chemicals and Fertilizers.
National Pharmaceutical Pricing Authority: A regulatory agency in India that fixes prices of pharmaceutical products, referred to as NPPA.
Drugs Prices Control Order, 2013: An order issued by the Government of India to regulate prices of drugs, referred to as DPCO 2013.
Government of India: The governing authority that issued the mentioned orders and notifications.
Essential Commodities Act, 1955: An act of the Parliament of India which seeks to ensure the delivery of certain commodities to consumers at fair prices.
Metformin: Medication mentioned in the table.
Teneligliptin: Medication mentioned in the table.
Dapagliflozin: Medication mentioned in the table.
Human Normal Immunoglobulin: Medication mentioned in the table.
Medroxyprogesterone Acetate: Medication mentioned in the table.
Glycopyrrolate: Medication mentioned in the table.
Formoterol Fumarate: Medication mentioned in the table.
Budesonide: Medication mentioned in the table.
Folic Acid: Medication mentioned in the table.
Pyridoxine Hydrochloride: Medication mentioned in the table.
Methylcobalamin: Medication mentioned in the table.
Vitamin D3: Medication mentioned in the table.
Framycetin: Medication mentioned in the table.
रिज(cid:7021)(cid:7069)ी स.ं डी.एल.- 33004/99 REGD. No. D. L.-33004/99
सी.जी.-डी.एल.-अ.-18042022-235178
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CG-DL-E-18042022-235178
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असाधारण
EXTRAORDINARY
भाग II—ख(cid:7003) ड 3—उप-ख(cid:7003)ड (ii)
PART II—Section 3—Sub-section (ii)
(cid:7079)ािधकार स े(cid:7079)कािशत
PUBLISHED BY AUTHORITY
स.ं 1744] नई (cid:7408)द(cid:7016)ली, सोमवार, अ(cid:7079)ैल 18, 2022/च(cid:7074)ै 28, 1944
No. 1744] NEW DELHI, MONDAY, APRIL 18, 2022/CHAITRA 28, 1944
रसायन और उव(cid:6981)रक मं(cid:7074)ालय
(औषध िवभाग)
(रा(cid:7398)ीय औषध म(cid:7016)ू य िनधा(cid:6981)रण (cid:7079)ािधकरण)
आदशे
नई (cid:7408)द(cid:7016)ली, 18 अ(cid:7079)ैल, 2022
का.आ. 1833(अ).—भारत सरकार के रसायन और उव(cid:6981)रक म(cid:7074)ं ालय (cid:7367)ारा जारी का. आ. 1394 (अ) तारीख 30 मई, 2013
और का. आ. 701(अ) तारीख 10 माच(cid:6981), 2016 के साथ प(cid:7407)ठत औषध (क(cid:7409)मत िनयं(cid:7074)ण) आदशे , 2013 के पैरा 5,11 और 15 (cid:7367)ारा (cid:7079)द(cid:7275)
शि(cid:7334)य(cid:7298) का (cid:7079)योग करते (cid:7263)ए, रा(cid:7398)ीय औषध मू(cid:7016)य िनधा(cid:6981)रण (cid:7079)ािधकरण (िजसको संि(cid:6979)(cid:7385) (cid:7272)प म(cid:7286) एनपीपीए कहा जाता ह)ै नीचे क(cid:7409) सारणी
के (cid:7021)तंभ (6) म(cid:7286) िविन(cid:7416)द(cid:7397)(cid:6981) खुदरा मू(cid:7016)य को उ(cid:7334) सारणी के (cid:7021)तंभ (3), (4) और (5) म(cid:7286) त(cid:7004)(cid:7021)थानी (cid:7079)िवि(cid:7397)य(cid:7298) म(cid:7286) िविन(cid:7416)द(cid:7397)(cid:6981) (cid:7079)बलता, इकाई
(यूिनट) और िविनमा(cid:6981)ता और िवपणन कंपिनय(cid:7298) के नाम सिहत (cid:7021)तंभ (2) म(cid:7286) क(cid:7409) त(cid:7004)(cid:7021)थानी (cid:7079)िवि(cid:7397) म(cid:7286) स े(cid:7079)(cid:7004)येक क(cid:7409),व(cid:7021)तु एवं सेवा कर, य(cid:7408)द
कोई ह,ै को छोड़कर अिधकतम खुदरा मू(cid:7016)य के (cid:7272)प म(cid:7286) िनयत करती है ।
तािलका
(cid:7059)ं िविन(cid:7414)मि(cid:6981)त का (cid:7079)बलता इकाई िविनमात(cid:6981) ा और िवपणन कंपनी खुदरा
स ं नाम/(cid:7081)ाडं का नाम मू(cid:7016)य
((cid:7272).)
(1) (2) (3) (4) (5) (6)
1. मेटफो(cid:7414)म(cid:6981)न (ए(cid:6989)सट(cid:7286)डेड - (cid:7079)(cid:7004)येक अिलिपत बाइलेयड(cid:6981) गोली म(cid:7286): 1 गोली मैसस(cid:6981) एसोिसएटेड बायोटेक / 7.14
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड आईपी 500 मैसस(cid:6981) ड(cid:7016)े स लेबोरेटरीज
(cid:7407)रलीज़) + टेनेि(cid:6991)लि(cid:7009)टन
िमली(cid:7061)ाम (ए(cid:6989)सट(cid:7286)डेड -(cid:7407)रलीज़ के (cid:7272)प म(cid:7286))
2703 GI/2022 (1)2 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
(cid:7059)ं िविन(cid:7414)मि(cid:6981)त का (cid:7079)बलता इकाई िविनमात(cid:6981) ा और िवपणन कंपनी खुदरा
स ं नाम/(cid:7081)ाडं का नाम मू(cid:7016)य
((cid:7272).)
(1) (2) (3) (4) (5) (6)
गोली टेनेि(cid:6991)लि(cid:7009)टन हाइ(cid:7071)ो(cid:7081)ोमाइड हाइ(cid:7071)ेट
टेनेिलि(cid:6991)लि(cid:7009)टन 20 िमली(cid:7061)ाम के बराबर
2. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत गोली म(cid:7286): 1 गोली मैसस(cid:6981) ए(cid:6989)सीमेड 10.70
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न (cid:7079)ोपेनेिडयोल फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स / मैसस(cid:6981)
हाइ(cid:7071)ो(cid:6989)लोराइड मोनोहाइ(cid:7071)ेट डैपाि(cid:6991)ल(cid:7010)लोिज़न 10 एम(cid:6989)योर फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स
ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़ िलिमटेड
िमली(cid:7061)ाम के बराबर,
गोली
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड आईपी
1000 िमली(cid:7061)ाम (ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के
(cid:7272)प म(cid:7286))
3. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत बाईलेयड(cid:6981) गोली म(cid:7286): 1 गोली मैसस(cid:6981) िसनोकेम फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स 7.97
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न (cid:7079)ोपेनेिडयोल िलिमटेड / मैसस(cid:6981) नैटको फामा(cid:6981)
हाइ(cid:7071)ो(cid:6989)लोराइड मोनोहाइ(cid:7071)ेट डैपाि(cid:6991)ल(cid:7010)लोिज़न 10 िलिमटेड
(ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़ के
िमली(cid:7061)ाम के बराबर,
(cid:7272)प म(cid:7286)) गोली
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड आईपी
1000 िमली(cid:7061)ाम (ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के
(cid:7272)प म(cid:7286))
4. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत बाईलेयड(cid:6981) गोली म(cid:7286): 1 गोली मैसस(cid:6981) िसनोकेम फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स 10.70
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न (cid:7079)ोपेनेिडयोल िल. / मैसस(cid:6981) एप(cid:6989)े स
हाइ(cid:7071)ो(cid:6989)लोराइड मोनोहाइ(cid:7071)ेट डैपाि(cid:6991)ल(cid:7010)लोिज़न 10 लैबोरेटो(cid:7407)रज (cid:7079)ा. िलिमटेड
(ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़ के
िमली(cid:7061)ाम के बराबर,
(cid:7272)प म(cid:7286)) गोली
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड आईपी
1000 िमली(cid:7061)ाम (ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के
(cid:7272)प म(cid:7286))
5. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत गोली म(cid:7286): 1 गोली मैसस(cid:6981) ए(cid:6989)सीमेड 9.18
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न (cid:7079)ोपेनेिडयोल फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स / मैसस(cid:6981)
हाइ(cid:7071)ो(cid:6989)लोराइड मोनोहाइ(cid:7071)ेट डैपाि(cid:6991)ल(cid:7010)लोिज़न 10 एम(cid:6989)योर फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स
ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़ िलिमटेड
िमली(cid:7061)ाम के बराबर,
गोली
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड आईपी 500
िमली(cid:7061)ाम (ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के (cid:7272)प म(cid:7286))
6. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत बाईलेयड(cid:6981) गोली म(cid:7286): 1 गोली मैसस(cid:6981) िसनोकेम फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स 7.30
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न (cid:7079)ोपेनेिडयोल िलिमटेड / मैसस(cid:6981) नैटको फामा(cid:6981)
हाइ(cid:7071)ो(cid:6989)लोराइड मोनोहाइ(cid:7071)ेट डैपाि(cid:6991)ल(cid:7010)लोिज़न 10 िलिमटेड
(ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़ के
िमली(cid:7061)ाम के बराबर,
(cid:7272)प म(cid:7286)) गोली
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड आईपी 500
िमली(cid:7061)ाम (ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के (cid:7272)प म(cid:7286))
7. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत बाईलेयर गोली म(cid:7286): 1 गोली मैसस(cid:6981) िसनोकेम फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स 9.18
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न (cid:7079)ोपेनेिडयोल िलिमटेड / मैसस(cid:6981) एप(cid:6989)े स
हाइ(cid:7071)ो(cid:6989)लोराइड मोनोहाइ(cid:7071)ेट डैपाि(cid:6991)ल(cid:7010)लोिज़न 10 लैबोरेटो(cid:7407)रज (cid:7079)ा. िलिमटेड
(ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़ के
िमली(cid:7061)ाम के बराबर,
(cid:7272)प म(cid:7286)) गोली
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड आईपी 500
िमली(cid:7061)ाम (ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के (cid:7272)प म(cid:7286))
8. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत गोली म(cid:7286): 1 गोली मैसस(cid:6981) ए(cid:6989)सीमेड 7.29
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न (cid:7079)ोपेनेिडयोल फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स / मैसस(cid:6981)[भाग II—ख(cid:7003) ड 3(ii)] भारत का राजप(cid:7074) : असाधारण 3
(cid:7059)ं िविन(cid:7414)मि(cid:6981)त का (cid:7079)बलता इकाई िविनमात(cid:6981) ा और िवपणन कंपनी खुदरा
स ं नाम/(cid:7081)ाडं का नाम मू(cid:7016)य
((cid:7272).)
(1) (2) (3) (4) (5) (6)
हाइ(cid:7071)ो(cid:6989)लोराइड मोनोहाइ(cid:7071)ेट डैपाि(cid:6991)ल(cid:7010)लोिज़न 5 एम(cid:6989)योर फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स
ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़ िमली(cid:7061)ाम के बराबर, िलिमटेड
गोली
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड आईपी
1000 िमली(cid:7061)ाम (ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के
(cid:7272)प म(cid:7286))
9. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत गोली म(cid:7286): 1 गोली मैसस(cid:6981) एमएसएन लैबोरेटो(cid:7407)रज 7.29
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न 5 िमली(cid:7061)ाम, (cid:7079)ा. िल. / मैसस(cid:6981) यूएसवी
हाइ(cid:7071)ो(cid:6989)लोराइड िलिमटेड
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड
ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़
आईपी/यूएसपी 1000 िमली(cid:7061)ाम
गोली
(ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के (cid:7272)प म(cid:7286))
10. डैपाि(cid:6991)ल(cid:7010)लोिज़न + (cid:7079)(cid:7004)येक (cid:7408)फ(cid:7016)म-लेिपत गोली म(cid:7286): 1 गोली मैसस(cid:6981) एमएसएन लैबोरेटो(cid:7407)रज 6.16
मेटफो(cid:7414)म(cid:6981)न डपै ाि(cid:6991)ल(cid:7010)लोिज़न 5 िमली(cid:7061)ाम, (cid:7079)ा. िल. / मैसस(cid:6981) यूएसवी
हाइ(cid:7071)ो(cid:6989)लोराइड िलिमटेड
मेटफो(cid:7414)म(cid:6981)न हाइ(cid:7071)ो(cid:6989)लोराइड
ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज़
आईपी/यूएसपी 500 िमली(cid:7061)ाम
गोली
(ए(cid:6989)सट(cid:7286)डेड (cid:7407)रलीज के (cid:7272)प म(cid:7286))
11. (cid:7022)युमन नोम(cid:6981)ल (cid:7079)(cid:7004)येक वाईल म(cid:7286): (cid:7079)ित 1 मैसस(cid:6981) इंटास फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स
इ(cid:7013)युनो(cid:6991)लोबुिलन कुल (cid:7079)ोटीन 50 (cid:7061)ाम/ली, िमली िलिमटेड
आईपी 5% (आईजी
इ(cid:7013)युनो(cid:6991)लोबुिलन एम 6 (cid:7061)ाम / ली, (10
एम एं(cid:7407)रचेड)
इ(cid:7013)युनो(cid:6991)लोबुिलन ए 6 (cid:7061)ाम / ली, िमली
वाईल के
इ(cid:7013)युनो(cid:6991)लोबुिलन जी 38 (cid:7061)ाम / ली,
177.8
िलए)
(cid:6991)लूकोज मोनोहाइ(cid:7071)ेट ((cid:7021)टे(cid:7011)लाईजर) 27.5
5
(cid:7061)ाम / ली,
सोिडयम (cid:6989)लोराइड 4.56 (cid:7061)ाम / ली,
इंज(cid:6989)े शन के िलए पानी (cid:6989)यू. एस.
िड(cid:7021)(cid:7069)ी(cid:7011)यूटर आईजी जी सब(cid:6989)लास 62%
आईजी जी 1,27% आईजी जी 2, 1%
आईजी जी 3,10% आईजी जी 4
12. म(cid:7071)े ो(cid:6989)सी(cid:7079)ोजे(cid:7021)टेरोन (cid:7079)(cid:7004)येक अिलिपत स(cid:7021)ट(cid:7286)ड (cid:7407)रलीज़ गोली म(cid:7286): 1 गोली मसै स(cid:6981) िसनोकेम फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स 14.04
एसीटेट स(cid:7021)ट(cid:7286)ड (cid:7407)रलीज म(cid:7071)े ो(cid:6989)सी(cid:7079)ोजे(cid:7021)टेरोन एसीटेट आईपी 30 िलिमटेड / मैसस(cid:6981) सीरम
गोली इं(cid:7021)टी(cid:7351)ूट ऑफ इंिडया (cid:7079)ा.
िमली(cid:7061)ाम
िलिमटेड
13. म(cid:7071)े ो(cid:6989)सी(cid:7079)ोजे(cid:7021)टेरोन (cid:7079)(cid:7004)येक अिलिपत स(cid:7021)ट(cid:7286)ड (cid:7407)रलीज़ गोली म(cid:7286): 1 गोली मैसस(cid:6981) िसनोकेम फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स 14.04
एसीटेट एसआर गोली म(cid:7071)े ो(cid:6989)सी(cid:7079)ोजे(cid:7021)टेरोन एसीटेट आईपी 30 िलिमटेड / मैसस(cid:6981) टोर(cid:7286)ट
फामा(cid:6981)(cid:7021)यु(cid:7407)टक(cid:7016)स िलिमटेड
िमली(cid:7061)ाम
14. (cid:6991)लाइको(cid:7079)ाइरोलेट + (cid:7079)(cid:7004)येक ए(cid:6989)चुएशन डेलीवस(cid:6981): 1 मैसस(cid:6981) ज़ाईडस ह(cid:7016)े थकेयर िल. 8.63
फॉम(cid:7299)टेरोल (cid:7010)यूमरेट + (cid:6991)लाइको(cid:7079)ाइरोलेट आईपी 9 एमसीजी एमडीआई
बुडसे ोनाइड इनहेलेशन
फॉम(cid:7299)टेरोल (cid:7010)यूमरेट डाइहाइ(cid:7071)ेट आईपी
फॉम(cid:7299)टेरोल (cid:7010)यूमरेट 4.8 एमसीजी के
बराबर
बुडसे ोनाइड आईपी 160 एमसीजी
15. फोिलक एिसड, (cid:7079)(cid:7004)येक अिलिपत माउथ िडसॉ(cid:7410)(cid:7016)वंग गोली 1 गोली मैसस(cid:6981) यूिनसन फामा(cid:6981)(cid:7021)यू(cid:7407)टक(cid:7016)स 6.70
म(cid:7286): (cid:7079)ा.िल.
पाइ(cid:7407)रडोि(cid:6989)सन4 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
(cid:7059)ं िविन(cid:7414)मि(cid:6981)त का (cid:7079)बलता इकाई िविनमात(cid:6981) ा और िवपणन कंपनी खुदरा
स ं नाम/(cid:7081)ाडं का नाम मू(cid:7016)य
((cid:7272).)
(1) (2) (3) (4) (5) (6)
हाइ(cid:7071)ो(cid:6989)लोराइड, फोिलक एिसड आईपी 5 िम.(cid:7061)ा.
िमथाइलकोबालािमन पाइ(cid:7407)रडोि(cid:6989)सन हाइ(cid:7071)ो(cid:6989)लोराइड आईपी
और िवटािमन डी3 3 िम.(cid:7061)ा.
गोली िमथाइलकोबालािमन आईपी 1500
एमसीजी
िवटािमन डी3 आईपी 1000 आईयू
%
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mi;qZDr nh xbZ lkj.kh ds LrHa k ¼6½ esa fofufnZ"V [kqnjk ewY; fu/kkZfjr djsaxsA
¼[k½ vxj fuekZrkvksa u s mi;qZD`r lkj.kh ds LraHk (6) esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS
;k ;g ns; gS rks os oLrq ,o a lsok dj dks tksM+ ldrs gSaA
¼x½ vkS"k/k ¼ewY; fu;=a .k½ vkns'k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr fuekZrkvksa dks mi;qZDr lkj.kh ds LrHa k
¼6½ esa fofufnZ"V [kqnjk ewY; ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, [kqnjk ewY; fu/kkZfjr djsaA fuekZrk vkS"k/k
¼ewY; fu;=a .k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ V esa vf/klwpuk dh rkjh[k ls ,d ewY; lwph ,uihih, dks
vkbZihMh,e,l ds ek/;e ls tkjh djsa rFkk mldh dkih jkT; vkS"kf/k fu;=a dksa vkSj fofuekZrk forjdksa dks tkjh djsaA
¼?k½ vkS"k/k ¼ewY; fu;=a .k½ vkn's k] 2013 ds 24 (4) ds mica/kksa ds vuqlkj izR;ds QqVdj fodzsrk vkSj forjd fofuekZrk }kjk
fn, x, :i ea s ,sls ifjlj] tgk a dkjckj dks bl izdkj fd;k tk jgk gS fd mlls ijke'kZ ds bPNqd fdlh O;fDr ds fy,
igqap vklku gks] ogk a mlds fdlh lgtn`’; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks laiznf'kZr djxs kA
¼M-½ mi;qZDr xSj vf/kdre dher ¼[kqnjk ewY;½ dsoy mi;ZqDr fuekZrk@foi.ku ds fy, ykxw gS tSlk fd mUgkaus s vkS"k/k
¼ewY; fu;=a .k½ vkns'k] 2013 ds rgr vuqc) ewY; fu/kkZj.k@la'kk/s ku ds fy, QkWeZ I ij tek fd;k x;k Fkk vkSj ljdkj
}kjk fu/kkZfjr lHkh ykxw oS/kkfud vko';drkvksa dh iwfrZ ds v/khu izklafxd fof/k;ksa@fu;eksa ds vUrxZr tSlk fd
dsUnzh;@jkT; ykblsflax vkWFkksfjVh ds l{ke izkf/kdkjh }kjk esU;wQsDpfjax ykblsal eatwjh ds rgr lacaf/kr fofufeZr
fuekZrk@foi.ku dEifu;ka tks vuqikyu djrh gaAS
¼p½ fofuekZrk ;k foi.ku dEiuh] mijksDr fofufeZfr;ksa vkSj fofufnZ"V 'krks± dk ikyu ugh a djrh gSa rks os vko';d oLrq,¡
vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvks] 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizHkkfjr jkf'k dk s tek djus ds
fy, nk;h gkaxs sA
¼N½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V fofufeZfr;ksa ds iSdksa dh [kqnjk ewY;
fu;r gksu s ds ifj.kkeLo#i] vkns'k tks fd bl vkns'k ls iwoZ tkjh gq, gS] Lor% gh fujLr gks tk;saxsA
[कां. सं. /228/96/2022/एफ/ फा.स.ं8(96)/2022/डी.पी./एनपीपीए-डी.वी.-II]
izlsuthr nkl] mi funs'kd
MINISTRY OF CHEMICALS AND FERTILIZERS
(Department of Pharmaceuticals)
(NATIONAL PHARMACEUTICAL PRICING AUTHORITY)
ORDER
New Delhi, the 18th April, 2022
S.O. 1833(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[भाग II—ख(cid:7003) ड 3(ii)] भारत का राजप(cid:7074) : असाधारण 5
(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. Metformin (extended- Each uncoated bilayered tablet 1 Tablet M/s Associated
release) + Teneligliptin contains: Biotech / M/s Dales
Tablet Metformin Hydrochloride IP Laboratories
7.14
500mg (as Extended-Release)
Teneligliptin Hydrobromide
hydrate eq. to Teneligliptin
20mg
2. Dapagliflozin + Each film-coated tablet 1 Tablet M/s Exemed 10.70
Metformin contains: Pharmaceuticals / M/s
Hydrochloride Dapagliflozin Propanediol Emcure
Extended release Monohydrate eq. to Pharmaceuticals
Tablet Dapagliflozin 10mg, Limited
Metformin Hydrochloride IP
1000mg (As Extended release
form)
3. Dapagliflozin + Each film-coated bilayered 1 Tablet M/s Synokem
Metformin tablet contains: Pharmaceuticals Ltd. /
Hydrochloride (As Dapagliflozin Propanediol M/s Natco Pharma Ltd.
Extended release form) Monohydrate eq. to
7.97
Tablet Dapagliflozin 10mg,
Metformin Hydrochloride IP
1000mg (As Extended release
form)
4. Dapagliflozin + Each film-coated bilayered 1 Tablet M/s Synokem
Metformin tablet contains: Pharmaceuticals Ltd. /
Hydrochloride (As Dapagliflozin Propanediol M/s Apex Laboratories
Extended release form) Monohydrate eq. to Private Limited
10.70
Tablet Dapagliflozin 10mg,
Metformin Hydrochloride IP
1000mg (As Extended release
form)
5. Dapagliflozin + Each film-coated tablet 1 Tablet M/s Exemed 9.18
Metformin contains: Pharmaceuticals / M/s
Hydrochloride Dapagliflozin Propanediol Emcure
Extended release Monohydrate eq. to Pharmaceuticals
Tablet Dapagliflozin 10mg, Limited
Metformin Hydrochloride IP
500mg (As Extended release
form)
6. Dapagliflozin + Each film-coated bilayered 1 Tablet M/s Synokem
Metformin tablet contains: Pharmaceuticals Ltd. /
Hydrochloride (As Dapagliflozin Propanediol M/s Natco Pharma Ltd.
7.30
Extended release form) Monohydrate eq. to
Tablet Dapagliflozin 10mg,6 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
Sl. Name of the Strength Unit Manufacturer & Retail
No. Formulation / Brand Marketing Company Price
Name (Rs.)
(1) (2) (3) (4) (5) (6)
Metformin Hydrochloride IP
500mg (As Extended release
form)
7. Dapagliflozin + Each film-coated bilayer tablet 1 Tablet M/s Synokem
Metformin contains: Pharmaceuticals Ltd. /
Hydrochloride (As Dapagliflozin Propanediol M/s Apex Laboratories
Extended release form) Monohydrate eq. to Private Limited
Tablet Dapagliflozin 10mg, 9.18
Metformin Hydrochloride IP
500mg (As extended release
form)
8. Dapagliflozin + Each film-coated tablet 1 Tablet M/s Exemed 7.29
Metformin contains: Pharmaceuticals / M/s
Hydrochloride Dapagliflozin Propanediol Emcure
Extended release Monohydrate eq. to Pharmaceuticals
Tablet Dapagliflozin 5mg, Limited
Metformin Hydrochloride IP
1000mg (As extended release
form)
9. Dapagliflozin + Each film-coated tablet 1 Tablet M/s MSN Laboratories
Metformin contains: Pvt. Ltd. / M/s USV
Hydrochloride Dapagliflozin 5mg, Limited
7.29
Extended release Metformin Hydrochloride
Tablet IP/USP 1000mg (As extended
release form)
10. Dapagliflozin + Each film-coated tablet 1 Tablet M/s MSN Laboratories 6.16
Metformin contains: Pvt. Ltd. / M/s USV
Hydrochloride Dapagliflozin 5mg, Limited
Extended release Metformin Hydrochloride
Tablet IP/USP 500mg (As extended
release form)
11. Human Normal Each vial contains: Per 1 ml M/s Intas
Immunoglobulin for Total Protein 50 g/L, (for 10 ml Pharmaceuticals Ltd
Intravenous use IP 5% Immunoglobulin M 6g/L, vial)
(Ig M Enriched) Immunoglobulin A 6g/L,
Immunoglobulin G 38g/L,
Glucose Monohydrate (as 177.85
stabilizer) 27.5g/L,
Sodium Chloride 4.56g/L, Water
for injection q. s.
Distribution of Ig G subclass is
approx.
62%IgG1,27%IgG2,1%IgG3,10
%IgG4
12. Medroxyprogesterone Each uncoated sustained 1 Tablet M/s Synokem
Acetate sustained release tablet contains: Pharmaceuticals Ltd. / 14.04
release Tablet Medroxyprogesterone Acetate IP M/s Serum Institute of
30mg India Pvt. Ltd.
13. Medroxyprogesterone Each uncoated sustained 1 Tablet M/s Synokem
Acetate SR Tablet release tablet contains: Pharmaceuticals[भाग II—ख(cid:7003) ड 3(ii)] भारत का राजप(cid:7074) : असाधारण 7
Sl. Name of the Strength Unit Manufacturer & Retail
No. Formulation / Brand Marketing Company Price
Name (Rs.)
(1) (2) (3) (4) (5) (6)
Medroxyprogesterone Acetate IP Limited / M/s Torrent
30mg Pharmaceuticals Ltd. 14.04
14. Glycopyrrolate + Each actuation delivers: 1 MDI M/s Zydus Healthcare
Formoterol Fumarate + Glycopyrrolate IP 9mcg Ltd. 8.63
Budesonide Inhalation Formoterol Fumarate Dihydrate
IP eq. to Formoterol Fumarate
4.8mcg
Budesonide IP 160mcg
15. Folic Acid, Pyridoxine Each uncoated mouth 1 tablet M/s Unison
Hydrochloride, dissolving tablet contains: Pharmaceuticals Pvt.
Methylcobalamin & Folic Acid IP 5mg Ltd.
Vitamin D3 Tablet Pyridoxine Hydrochloride IP
3mg
Methylcobalamin IP 1500mcg 6.70
Vitamin D3 IP 1000 IU
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/228/96/2022/F/F. No. 8(96)/2022/D.P./NPPA-Div.-II]
PRASENJIT DAS, Dy. Director
ubZ fnYyh] 18 vçSy] 2022
.—Hkkjr ljdkj ds jlk;u vkSj moZjd ea=ky; }kjk tkjh dk- vk- 1394¼v½ rkjh[k 30
ebZ] 2013 vkSj dk-vk- 701¼v½ rkjh[k 10 ekpZ] 2016 ds lkFk ifBr vkS"k/k ¼dher fu;a=.k½ vkns'k] 2013 ds iSjk8 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
4, 6, 10, 11, 14, 16, 17 vkSj 18 }kjk iznRr 'kfDr;ksa dk iz;ksx djrs gq, vkSj Hkkjr ljdkj esa jlk;u ,oa
moZjd ea=ky; ¼jk"Vªh; vkS"k/k ewY; fu/kkZj.k izkf/kdj.k½ ds dk- vk- 1503¼v½ fnukad 30 ekpZ] 2022 ¼Ø- la- 6½ ds
vkns'k ds vf/kØe.k esa tgka rd mldk laca/k uhps dh lkj.kh ds fofufeZfr iSd ls gS] mu ckrksa ds flok;
vf/kØkUr djrs gq, ftUgsa ,sls vf/kØe.k ds iwoZ fd;k x;k gS ;k djus dk yksi fd;k x;k gS] jk”Vªh; vkS"k/k
ewY; fu/kkZj.k izkf/kdj.k uhps dh lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher dks mDr lkj.kh ds LraHk ¼3½
vkSj ¼4½ esa Øe'k% rRLFkkuh izfof"V;ksa esa fofufnZ"V [kqjkd :i ,oa izcyrk vkSj bdkbZ lfgr ml lkj.kh ds LraHk
¼2½ esa dh rRLFkkuh izfof”V esa fofufnZ"V vuqlwfpr fofufeZfr;ksa esa ls izR;sd dh] oLrq ,oa lsok dj] ;fn dksbZ gS]
dks NksM+dj vf/kdre dher ds :i esa fu;r djrh gS%
(1) (2) (3) (4) (5)
1. (cid:293)ेमीसे(cid:465)टन (cid:272)(cid:551)म 0.5% 1 (cid:274)ाम 1.19
¼d½ ljdkj }kjk bl izdkj fu;r dh xbZ vkSj vf/klwfpr dh xbZ vf/kdre dher ¼/ku oLrq ,o a lsok dj] tks ykx w gksa½
ls vf/kd dher ij vuqlwfpr fofufeZfr;ksa ds czkaMsM ;k tsusfjd ;k nksuksa :ikarjksa dks csp jgs vuqlwfpr fofufeZfr;ksa
ds lHkh fofuekZrk] mi;qZDr lkj.kh ds LraHk (5) ea s of.kZr vf/kdre dher ¼/ku oLrq ,o a lsok dj] tks ykxw gka½s ls
vf/kd lHkh ,slh fofufeZr;ksa dh dher dk v/kkseq[kh iqujh{k.k djsaxAs
¼[k½ lHkh ekStwnk fuekZrkvksa dks mi;qZDr dfFkr vuqlwfpr fofufeZfr;ksa ds vf/kdre [kqnjk dher mi;qZDr lkj.kh ds LraHk
¼5½ esa fofufnZ"V vf/kdre dher oLrq ,oa lsok dj lfgr ls de gS rks] tgka dgh Hkh ykxw gks] vkS"k/k ¼ewY; fu;=a .k½
vkns'k] 2013 ds iSjkxzkQ 13(2) ds vuqlkj mldks ekStwnk vf/kdre [kqnjk dher dks cuk, j[kuk gksxkA
¼x½ vxj fuekZrkvksa us mi;qZDr lkj.kh ds LraHk (5) esa of.kZr vf/kdre dher ij ljdkj dks okLro esa Hkqxrku fd;k gS
;k ;g ns; gS rks os oLrq ,o a lsok dj dks tksM+ ldrs gSaA
¼?k½ vkS"k/k ¼ewY; fu;=a .k½ vkn's k] 2013 ds iSjkxzkQ 11 esa fn, x, izko/kkuksa ds rgr lEcfU/kr fuekZrkvksa dks mi;qZDr
lkj.kh ds LraHk ¼5½ esa fofufnZ"V vf/kdre dher ds vk/kkj ij vuqlwfpr fofufeZfr;ksa ds iSdksa ds fy, vf/kdre
dher fu/kkZfjr djsaA fuekZrk vkS"k/k ¼ewY; fu;=a .k½ vkns'k] 2013 ds iSjkxzkQ 24 ds rgr QkWeZ&V esa vf/klwpuk dh
rkjh[k ls vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih, dks ,d ewY; lwph tkjh djsa rFkk mldh dkWih jkT; vkS"kf/k
fu;a=dksa vkSj fofuekZrk forjdksa dks tkjh djsaA
¼M+½ vkS"k/k ¼ewY; fu;=a .k½ vkns'k] 2013 ds iSjk 24(4) ds mic/a kksa ds vuqlkj izR;sd QqVdj foØsrk vkSj forjd fofuekZrk
}kjk fn, x, :i esa ,sls ifjlj] tgk a dkjksckj dks bl izdkj fd;k tk jgk gS fd mlls ijke'kZ ds bPNqd fdlh
O;fDr ds fy, igqap vklku gks] ogka mlds fdlh lgtn`'; Hkkx ij dher lwph vkSj iwjd lwph] ;fn dksbZ gks] dks
laiznf'kZr djxs kA
¼p½ mi;qZDr lkj.kh esa ;Fkk&fofufnZ"V [kqnjk ;k izcyrk ;k nksuksa ds lkFk vuqlwfpr fofufeZfr dk dksbZ ekStwnk fofuekZrk
vkS"k/k ewY; fu;=a .k vkns'k] 2013 ds iSjk 2¼;w½ ds vuqlkj dksbZ ubZ vkS"kf/k dks ykap djrk gS rk s ,sls ekStwnk
fofuekZrk dh vkS"k/k ¼ewY; fu;=a .k½ vkns'k 2013 dh vuqlwph&II ds varxZr ;Fkk&fofufnZ"V QkeZ&I esa ,uihih, dk s
,slh ubZ vkS"kf/k ds iwoZ ewY; vuqeksnu gsrq vkosnu djuk gkxs kA
¼N½ mi;qZDr vuqlwfpr fofufeZfr;kas dh mRiknu@vk;kr vkSj fcØh ds lEcU/k esa fuekZrkvksa dks vkS"k/k ¼eYw ; fu;=a .k½
vkns'k] 2013 ds lwph II ds QkWeZ III dks vkbZihMh,e,l ds ek/;e ls Hkjdj ,uihih, dk s gj frekgh dh fjiksVZ izLrqr
djsxkA mi;qZDr vuqlwfpr fofufeZfr;ksa ds fuekZ.k dk s dksbZ fuekrZ k mRiknu cUn djus dk bPNqd gks rks bldh lwpuk
,uihih, dks voxr djk;xs kA blds lEcU/k esa vxj vuqlwfpr fofufeZfr;ksa ds mRiknu vkSj vk;kr dks cUn djus[भाग II—ख(cid:7003) ड 3(ii)] भारत का राजप(cid:7074) : असाधारण 9
dk bPNqd gS rks cUn dju s dh frfFk ls N% eghu s igys vuqlwph II ds QkWeZ IV esa Hkjdj ,uihih, dks izLrqr djsxkA
¼Tk½ fofuekZrk ;k foi.ku dEiuh] mijksDr dfFkr lkj.kh esa n'kkZ;s vf/kdre ewY; vkSj 'krks± dk ikyu ugha djrh gSa rks os
vko';d oLrq,¡ vf/kfu;e] 1955 ds lkFk ifBr Mhihlhvk]s 2013 ds izko/kkuksa ds v/khu C;kt lfgr vf/kizHkkfjr jkf'k
dks tek djus ds fy, mRrjnk;h gksaxAs
¼>½ bl vkns'k esa mijksDr lkj.kh ds LraHk ¼2½ esa dh rRLFkkuh izfof"V esa fofufnZ"V ,ls h fofufeZfr;ksa ds iSdksa dh vf/kdre
dher fu;r gksu s ds ifj.kkeLo#i] vf/kdre ;k [kqnjk ewY; fu/kkZfjr vkns'k ;fn dksbZ gk]s tks fd bl vkn's k ls iwoZ
tkjh gq, gS] Lor% gh vf/kØe.k gk s tk;saxsA
[कां. सं. /228/96/2022/एफ/ फा.स.ं8(96)/2022/डी.पी./एनपीपीए-डी.वी.-II]
izlsuthr nkl] mi funs'kd
ORDER
New Delhi, the 18th April, 2022
S.O. 1834(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) at Sl. No. 6 of SO 1503(E) dated 30th March, 2022 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 (hereinafter referred as NPPA) hereby fixes the price as specified in column (5) of
the table herein below as ceiling price exclusive of goods and services 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 Dosage form & Strength Unit Ceiling
Scheduled Formulation Price (Rs.)
(1) (2) (3) (4) (5)
1. Framycetin Cream 0.5% 1 GM 1.19
Note:
(a) All manufacturers of scheduled formulation, selling the branded or generic or both the versions of scheduled
formulations at a price higher than the ceiling price (plus Goods and Services Tax 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 goods and services tax 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 goods and services tax 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 goods and services tax 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 scheduled10 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(ii)]
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/228/96/2022/F/F. No. 8(96)/2022/D.P./NPPA-Div.-II]
PRASENJIT DAS, 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.