SlideShare a Scribd company logo
1 of 4
Download to read offline
Compiled by-Shamon Ahmad, M.Pharma (Q.A) Chandigarh Group of Colleges, Landran,
Mohali(Punjab India)email-shmmon@gmail.com on Date-25/12/2012

Drugs Price Control Order (DPCO) 1995
The Drugs Price Control Order (DPCO), 1995 is an order issued by the Government of India
under Section 3 of the Essential Commodities Act, 1955 to regulate the prices of drugs. The
Order inter alia provides the list of price controlled drugs, procedures for fixation of prices of
drugs, method of implementation of prices fixed by Government and penalties for contravention
of provisions among other things. Drugs and formulations have been subjected to price control
for more than three decades now. The economic reforms initiated by the Government of India in
July 1991, trickled down to the Pharmaceutical Industry only in 1994 and that too partially. Price
control in a large number of industries has already been abolished.

Objectives of Drug Policy
As per the changes in Drug Policy, 1986 announced in September, 1994, the main objectives of
the Drug Policy are as under :
•
•
•
•

Providing abundant quanity, at reasonable prices of essential and life saving and
medicines of good quality.
Strengthening the quality control system over drugs and medicies production and
promoting the rational use of drugs in the country.
Creating an environment friendly to channelising new investment into the pharmaceutical
industry with an objective to boost cost-effective production with economic sizes and
introducing new technologies and new drugs.
Strengthening the indigenous capability for production of drugs.

About NPPA
For the purpose of implementing provisions of DPCO, powers of the Government have been
vested in the National Pharmaceutical Pricing Authority (NPPA). Drugs are essential for health of
the society. Drugs have been declared as essential and accordingly put under the Essential
Commodities Act. Only 74 out of 500 commonly used bulk drugs are kept under statutory price
control. All formulations containing these bulk drugs either in a single or combination form fall
under the price control category. However, the prices of other drugs can be regulated, if
warranted in public interest.
The NPPA was established on 29th August 1997 as an independent body of experts following the
Cabinet Committee’s decision in September 1994 while reviewing the Drug Policy. The
Authority, inter alia, has been entrusted with the task of fixation/revision of prices of
pharmaceutical products (bulk drugs and formulations), enforcement of provisions of the Drugs
(Prices Control) Order and monitoring the prices of controlled and decontrolled drugs in the
country.

Features of DPCO;
The essentail features of DPCO covers the following questions:
•

•
•
•
•
•

How are the prices of drugs and medicines in the controlled category regulated? There
are two prices for this fixed by the NPPA as per the provisions of DPCO Ceiling and
DPCONon Ceiling Price .
Ceiling Price is the single maximum selling price fixed that is applicable throughout the
country in the case of each bulk drug, which is under price control.
Non-Ceiling Price fixed by NPPA are specific to a particular pack size of scheduled
Ceiling
formulation of a particular company.
Whether NPPA has any role to regulate prices of non-scheduled drugs (drugs not under
non scheduled
direct price control)?
What margins are allowed to a Wholesaler and a Retailer as per DPCO, 1995?

FORM OF APPLICATION FOR APPROVAL OR REVISION OF
PRICE OF SCHEDULED FORMULATIONS.
1. Name of the Formulation.
2. Name of the Manufacturer.
3. Address of Registered/Head Office/ Administrative Office.
4. Address of the Factory.
5. Composition as per label claim and approved by Drug Control Authorities.
6. Drug Control Authority Permission Number and Date (copy to be enclosed).
(copy
7. Number and date of Industrial Licence/Small Scale Industry Registration/ Industrial
Entrepreneure Memorandum acknowledgement (copy to be enclosed).
8. Date of Commencement of Production.
9. Type of formulation: •

•
•

Type [Plain/ Coated Tablets, Multi layered sustained release/ Soft/ Hard/ Printed
Multi-layered
capsules (without/ with/ sealing band) / sterile/ non-sterile Liquid/ Powder/ Ointment/
non sterile
Cream etc.];
In case of Tablets please furnish average weight of 100 Tablets;
In case of Capsules please furnish size of capsule.
e

10. Type of packing [Aluminium/ Paper/ Cellophane/ Strips/ Blister/ Vials/ Ampoules/ White
Colour Bottles/ Tins/ Jars/ with/ without dropper/ cutting blades/ catch cover etc.].
11. Size of packs [10's/ 100's/ etc; 1ml/ 2ml/ 10 ml/ etc.; 5 gms/ 10 gms/ etc.].,
12. Number of Packs sold during the last accounting year and details of other packs of the same
formulation with their retail prices.
13. Break-up of Retail Price :Details

Existing Price if any*
(Rs./Pack)

Now Claimed
(Rs./Pack)

(a) Material Cost (as per S.No. 14d);
(b) Conversion Cost (as per norms);
(c) Packing Material Costs (as per S.No. 15 or
as per norms);
(d) Packing Charges;
(e) Ex-factory Cost (a to d);
(f) MAPE 100% on (e) above;
(g) Excise Duty;
(h) Retail Price (R.P.) (e+f+g).

* Existing Retail Price Approval Letter No. and Date - copy to be enclosed.

14. Material Cost
•
•
•

Batch Size (Nos./Litres/Kgs./etc);
No. of packs that can be theoretically obtained from the batch size as in (a) above;
Material Cost for the batch size as in (a) above;

S.No. Name of the
Material

Unit Theoretical
Quantity

Actual
Total
Overages (4+5) Quantity

Rate/Unit Cost for the
Batch(6 x 7)

(1)

(3) (4)

(5)

(7)

(2)

Imported
1.
2.
3.
etc.
Indigenous
1.
2.
3.
etc.
Total ................................................... :
Add: Process loss as per norms ..............% :
Total Material Cost ................................. :
Total Material Cost
Material Cost per Pack = -----------------------------

(6)

(8)
Theoretical No. of Packs

15. Packing Material Costs:Packs of .......................................
Batch Size : ..................... Tablets/Gms/etc. each
S.No.

Name of the
Packing Material

Unit Rate per
Unit (Rs.)

Qty. Required
per Batch

Value of Packing
Materials/Batch
(Nos/Kgs etc)(Rs.)

(1)

(2)

(3)

(5)

(6)

(4)

Imported
1.
2.
3.
etc.
Indigenous
1.
2.
3.
etc.

Total ................................................... :
Add: Process loss as per norms ..............% :
Total Packing Material Cost ................................. :
Total Packing Material Cost
Packing Material Cost per Pack = ----------------------------------------No. of Packs as per Batch size

More Related Content

What's hot

Drug Price control order 2013
Drug Price control order 2013Drug Price control order 2013
Drug Price control order 2013Ramkrishna Bannai
 
National pharmaceutical pricing athourity (nppa)
National pharmaceutical pricing athourity (nppa)National pharmaceutical pricing athourity (nppa)
National pharmaceutical pricing athourity (nppa)bdvfgbdhg
 
Drug and price control order
Drug and price control orderDrug and price control order
Drug and price control orderSajalChowdhury4
 
Drug Price Control Order -2013
Drug Price Control Order -2013Drug Price Control Order -2013
Drug Price Control Order -2013Ganesh Shevalkar
 
Drug pricing in international markets
Drug pricing in international marketsDrug pricing in international markets
Drug pricing in international marketsPreeti Gulati
 
The drugs (prices control) order,
The drugs (prices control) order,The drugs (prices control) order,
The drugs (prices control) order,Sharon Vijayanand
 
National pharmaceutical pricing authority
National pharmaceutical pricing authority National pharmaceutical pricing authority
National pharmaceutical pricing authority TiyaPatel2
 
Nppa,gst& its impact
Nppa,gst& its impactNppa,gst& its impact
Nppa,gst& its impactRituJain142
 
Drug and price controle order
Drug and price controle orderDrug and price controle order
Drug and price controle orderShubham Sharma
 
Compendium of Notified Ceiling Prices of Scheduled Drugs - 2015
Compendium of Notified Ceiling Prices of Scheduled Drugs - 2015 Compendium of Notified Ceiling Prices of Scheduled Drugs - 2015
Compendium of Notified Ceiling Prices of Scheduled Drugs - 2015 Anup Soans
 
Pakistan Drug Pricing Policy
Pakistan Drug Pricing PolicyPakistan Drug Pricing Policy
Pakistan Drug Pricing PolicyCepal & Co.
 
National pharmaceutical pricing authority with drugs price control order (dpc...
National pharmaceutical pricing authority with drugs price control order (dpc...National pharmaceutical pricing authority with drugs price control order (dpc...
National pharmaceutical pricing authority with drugs price control order (dpc...Tushar Morankar
 
pharmaceutical policy - 2002
 pharmaceutical policy - 2002 pharmaceutical policy - 2002
pharmaceutical policy - 2002Suvarta Maru
 
History of price regulation in India
History of price regulation in IndiaHistory of price regulation in India
History of price regulation in IndiaRavish Yadav
 
Priscription drug user free act......sn
Priscription drug user free act......snPriscription drug user free act......sn
Priscription drug user free act......snbdvfgbdhg
 

What's hot (20)

Drug Price control order 2013
Drug Price control order 2013Drug Price control order 2013
Drug Price control order 2013
 
National pharmaceutical pricing athourity (nppa)
National pharmaceutical pricing athourity (nppa)National pharmaceutical pricing athourity (nppa)
National pharmaceutical pricing athourity (nppa)
 
Drug and price control order
Drug and price control orderDrug and price control order
Drug and price control order
 
Drug Price Control Order -2013
Drug Price Control Order -2013Drug Price Control Order -2013
Drug Price Control Order -2013
 
Drug pricing in international markets
Drug pricing in international marketsDrug pricing in international markets
Drug pricing in international markets
 
Dpco as per pci
Dpco as per pciDpco as per pci
Dpco as per pci
 
The drugs (prices control) order,
The drugs (prices control) order,The drugs (prices control) order,
The drugs (prices control) order,
 
National pharmaceutical pricing authority
National pharmaceutical pricing authority National pharmaceutical pricing authority
National pharmaceutical pricing authority
 
Nppa,gst& its impact
Nppa,gst& its impactNppa,gst& its impact
Nppa,gst& its impact
 
Drug and price controle order
Drug and price controle orderDrug and price controle order
Drug and price controle order
 
Compendium of Notified Ceiling Prices of Scheduled Drugs - 2015
Compendium of Notified Ceiling Prices of Scheduled Drugs - 2015 Compendium of Notified Ceiling Prices of Scheduled Drugs - 2015
Compendium of Notified Ceiling Prices of Scheduled Drugs - 2015
 
Pakistan Drug Pricing Policy
Pakistan Drug Pricing PolicyPakistan Drug Pricing Policy
Pakistan Drug Pricing Policy
 
Drug pricing policy india
Drug pricing policy indiaDrug pricing policy india
Drug pricing policy india
 
Ska
SkaSka
Ska
 
National pharmaceutical pricing authority with drugs price control order (dpc...
National pharmaceutical pricing authority with drugs price control order (dpc...National pharmaceutical pricing authority with drugs price control order (dpc...
National pharmaceutical pricing authority with drugs price control order (dpc...
 
pharmaceutical policy - 2002
 pharmaceutical policy - 2002 pharmaceutical policy - 2002
pharmaceutical policy - 2002
 
History of price regulation in India
History of price regulation in IndiaHistory of price regulation in India
History of price regulation in India
 
New drug policy 1994
New drug policy 1994New drug policy 1994
New drug policy 1994
 
Drug price
Drug priceDrug price
Drug price
 
Priscription drug user free act......sn
Priscription drug user free act......snPriscription drug user free act......sn
Priscription drug user free act......sn
 

Viewers also liked

Pharmaceutical pricing and reimbursement usa
Pharmaceutical pricing and reimbursement usaPharmaceutical pricing and reimbursement usa
Pharmaceutical pricing and reimbursement usaNeha Kalal
 
Chapter 4 drug cosmetic stability
Chapter 4   drug cosmetic stabilityChapter 4   drug cosmetic stability
Chapter 4 drug cosmetic stabilityMalou Mojares
 
Pharmaceutical Waste Treatment and Disposal Practices
Pharmaceutical Waste Treatment and Disposal PracticesPharmaceutical Waste Treatment and Disposal Practices
Pharmaceutical Waste Treatment and Disposal Practicesrekhac86
 
Biological Drugs – practical considerations for handling and storage
Biological Drugs – practical considerations for handling and storageBiological Drugs – practical considerations for handling and storage
Biological Drugs – practical considerations for handling and storagePharmaxo
 
Blister & strip packaging
Blister & strip packaging Blister & strip packaging
Blister & strip packaging Anil Pethe
 
PHARMACEUTICAL WASTE MANAGEMENT IN INDIA
PHARMACEUTICAL WASTE MANAGEMENT IN INDIAPHARMACEUTICAL WASTE MANAGEMENT IN INDIA
PHARMACEUTICAL WASTE MANAGEMENT IN INDIAAakashdeep Raval
 
Hospital waste management
Hospital waste management Hospital waste management
Hospital waste management Nikhil Bansal
 
Organization of hospital pharmacy slides.
Organization of hospital pharmacy slides.Organization of hospital pharmacy slides.
Organization of hospital pharmacy slides.Artham Yadhav RX
 
Health care Waste management
Health care Waste managementHealth care Waste management
Health care Waste managementUjwal Gautam
 
physical plant and its equipments (hospital pharmacy)
physical plant and its equipments (hospital pharmacy)physical plant and its equipments (hospital pharmacy)
physical plant and its equipments (hospital pharmacy)rida abid
 
Drug distribution in hospital pharmacy
Drug distribution in hospital pharmacyDrug distribution in hospital pharmacy
Drug distribution in hospital pharmacyRaju Sanghvi
 
PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.
PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.
PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.Akshay Joshi
 
Product & Pricing Strategies
Product & Pricing StrategiesProduct & Pricing Strategies
Product & Pricing Strategiesguest082e19
 

Viewers also liked (20)

Hospital waste
Hospital waste Hospital waste
Hospital waste
 
Pharmaceutical pricing and reimbursement usa
Pharmaceutical pricing and reimbursement usaPharmaceutical pricing and reimbursement usa
Pharmaceutical pricing and reimbursement usa
 
Chapter 4 drug cosmetic stability
Chapter 4   drug cosmetic stabilityChapter 4   drug cosmetic stability
Chapter 4 drug cosmetic stability
 
Pharmaceutical Waste Treatment and Disposal Practices
Pharmaceutical Waste Treatment and Disposal PracticesPharmaceutical Waste Treatment and Disposal Practices
Pharmaceutical Waste Treatment and Disposal Practices
 
Basics of Prescription
Basics of PrescriptionBasics of Prescription
Basics of Prescription
 
Biological Drugs – practical considerations for handling and storage
Biological Drugs – practical considerations for handling and storageBiological Drugs – practical considerations for handling and storage
Biological Drugs – practical considerations for handling and storage
 
Good storage practice
Good storage practiceGood storage practice
Good storage practice
 
Blister & strip packaging
Blister & strip packaging Blister & strip packaging
Blister & strip packaging
 
PHARMACEUTICAL WASTE MANAGEMENT IN INDIA
PHARMACEUTICAL WASTE MANAGEMENT IN INDIAPHARMACEUTICAL WASTE MANAGEMENT IN INDIA
PHARMACEUTICAL WASTE MANAGEMENT IN INDIA
 
Hospital waste management
Hospital waste management Hospital waste management
Hospital waste management
 
Hospital pharmacy slides.
Hospital pharmacy slides.Hospital pharmacy slides.
Hospital pharmacy slides.
 
Organization of hospital pharmacy slides.
Organization of hospital pharmacy slides.Organization of hospital pharmacy slides.
Organization of hospital pharmacy slides.
 
Health care Waste management
Health care Waste managementHealth care Waste management
Health care Waste management
 
physical plant and its equipments (hospital pharmacy)
physical plant and its equipments (hospital pharmacy)physical plant and its equipments (hospital pharmacy)
physical plant and its equipments (hospital pharmacy)
 
Drug Storage & Maintenance
Drug Storage & MaintenanceDrug Storage & Maintenance
Drug Storage & Maintenance
 
Hospital waste management
Hospital waste managementHospital waste management
Hospital waste management
 
Drug distribution in hospital pharmacy
Drug distribution in hospital pharmacyDrug distribution in hospital pharmacy
Drug distribution in hospital pharmacy
 
PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.
PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.
PACKAGING OF TABLETS: TYPES, MATERIALS AND QC.
 
Product & Pricing Strategies
Product & Pricing StrategiesProduct & Pricing Strategies
Product & Pricing Strategies
 
Blister packing
Blister packingBlister packing
Blister packing
 

Similar to Drug price pdf

National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...Dr. Ambekar Abdul Wahid
 
drugpricecontrolorder(dpco)and national.pptx
drugpricecontrolorder(dpco)and national.pptxdrugpricecontrolorder(dpco)and national.pptx
drugpricecontrolorder(dpco)and national.pptxmathihadassa
 
NATIONAL PHARMACEUTICAL PRICING AUTHORITY.pptx
NATIONAL PHARMACEUTICAL PRICING AUTHORITY.pptxNATIONAL PHARMACEUTICAL PRICING AUTHORITY.pptx
NATIONAL PHARMACEUTICAL PRICING AUTHORITY.pptxJagat Pal Yadav
 
National Pharmaceutical Pricing Authority-WPS Office.pptx
National Pharmaceutical Pricing Authority-WPS Office.pptxNational Pharmaceutical Pricing Authority-WPS Office.pptx
National Pharmaceutical Pricing Authority-WPS Office.pptxSudipta Roy
 
National pharmaceutical pricing authority.pdf
National pharmaceutical pricing authority.pdfNational pharmaceutical pricing authority.pdf
National pharmaceutical pricing authority.pdfDarshanpatel609504
 
National Pharmaceutical Pricing Authority and DPCO 2013
National Pharmaceutical Pricing Authority and DPCO 2013National Pharmaceutical Pricing Authority and DPCO 2013
National Pharmaceutical Pricing Authority and DPCO 2013Ashish Chaudhari
 
Drug Price Control Order
Drug Price Control OrderDrug Price Control Order
Drug Price Control OrderIshitaDhingra1
 
NATIONAL PRICING AUTHORITY (1).ppt
NATIONAL PRICING AUTHORITY (1).pptNATIONAL PRICING AUTHORITY (1).ppt
NATIONAL PRICING AUTHORITY (1).pptDinesh150434
 
wwwww9. Drug Price control Order & National Drug Policy (2).pdf
wwwww9. Drug Price control Order & National Drug Policy (2).pdfwwwww9. Drug Price control Order & National Drug Policy (2).pdf
wwwww9. Drug Price control Order & National Drug Policy (2).pdfkusumAkki1
 
drugpricecontrolorder.pptx
drugpricecontrolorder.pptxdrugpricecontrolorder.pptx
drugpricecontrolorder.pptxIfraAzhar
 
patent-access-drugs
patent-access-drugspatent-access-drugs
patent-access-drugsRakhi Gupta
 
RPG Blizzard Case Study - RPGLS | Phase 2
RPG Blizzard Case Study - RPGLS | Phase 2RPG Blizzard Case Study - RPGLS | Phase 2
RPG Blizzard Case Study - RPGLS | Phase 2Himanshu Lohani
 
Drug Regulations in India Dr Surinder Singh.pdf
Drug Regulations in India Dr Surinder Singh.pdfDrug Regulations in India Dr Surinder Singh.pdf
Drug Regulations in India Dr Surinder Singh.pdfwasimankhan
 
pros & cons Of Pharmaceutical Industry In INDIA-2011
pros & cons Of Pharmaceutical Industry In INDIA-2011pros & cons Of Pharmaceutical Industry In INDIA-2011
pros & cons Of Pharmaceutical Industry In INDIA-2011Raghava Reddy
 
DRUG PRICE CONTROLE ORDER OR NATIONAL PHARMACEUTICAL PRICING AUTHORITY
DRUG PRICE CONTROLE ORDER OR NATIONAL PHARMACEUTICAL PRICING AUTHORITYDRUG PRICE CONTROLE ORDER OR NATIONAL PHARMACEUTICAL PRICING AUTHORITY
DRUG PRICE CONTROLE ORDER OR NATIONAL PHARMACEUTICAL PRICING AUTHORITYGAMPA kumar
 
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )JAYACHANDRA AKUTHOTA
 
National Pharmaceutical Pricing Authority
National Pharmaceutical Pricing AuthorityNational Pharmaceutical Pricing Authority
National Pharmaceutical Pricing AuthorityP.N.DESHMUKH
 

Similar to Drug price pdf (20)

National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...
 
NPPA-WPS Office.pptx
NPPA-WPS Office.pptxNPPA-WPS Office.pptx
NPPA-WPS Office.pptx
 
drugpricecontrolorder(dpco)and national.pptx
drugpricecontrolorder(dpco)and national.pptxdrugpricecontrolorder(dpco)and national.pptx
drugpricecontrolorder(dpco)and national.pptx
 
DPCO.pptx
DPCO.pptxDPCO.pptx
DPCO.pptx
 
NATIONAL PHARMACEUTICAL PRICING AUTHORITY.pptx
NATIONAL PHARMACEUTICAL PRICING AUTHORITY.pptxNATIONAL PHARMACEUTICAL PRICING AUTHORITY.pptx
NATIONAL PHARMACEUTICAL PRICING AUTHORITY.pptx
 
National Pharmaceutical Pricing Authority-WPS Office.pptx
National Pharmaceutical Pricing Authority-WPS Office.pptxNational Pharmaceutical Pricing Authority-WPS Office.pptx
National Pharmaceutical Pricing Authority-WPS Office.pptx
 
National pharmaceutical pricing authority.pdf
National pharmaceutical pricing authority.pdfNational pharmaceutical pricing authority.pdf
National pharmaceutical pricing authority.pdf
 
National Pharmaceutical Pricing Authority and DPCO 2013
National Pharmaceutical Pricing Authority and DPCO 2013National Pharmaceutical Pricing Authority and DPCO 2013
National Pharmaceutical Pricing Authority and DPCO 2013
 
Drug Price Control Order
Drug Price Control OrderDrug Price Control Order
Drug Price Control Order
 
Nppa
NppaNppa
Nppa
 
NATIONAL PRICING AUTHORITY (1).ppt
NATIONAL PRICING AUTHORITY (1).pptNATIONAL PRICING AUTHORITY (1).ppt
NATIONAL PRICING AUTHORITY (1).ppt
 
wwwww9. Drug Price control Order & National Drug Policy (2).pdf
wwwww9. Drug Price control Order & National Drug Policy (2).pdfwwwww9. Drug Price control Order & National Drug Policy (2).pdf
wwwww9. Drug Price control Order & National Drug Policy (2).pdf
 
drugpricecontrolorder.pptx
drugpricecontrolorder.pptxdrugpricecontrolorder.pptx
drugpricecontrolorder.pptx
 
patent-access-drugs
patent-access-drugspatent-access-drugs
patent-access-drugs
 
RPG Blizzard Case Study - RPGLS | Phase 2
RPG Blizzard Case Study - RPGLS | Phase 2RPG Blizzard Case Study - RPGLS | Phase 2
RPG Blizzard Case Study - RPGLS | Phase 2
 
Drug Regulations in India Dr Surinder Singh.pdf
Drug Regulations in India Dr Surinder Singh.pdfDrug Regulations in India Dr Surinder Singh.pdf
Drug Regulations in India Dr Surinder Singh.pdf
 
pros & cons Of Pharmaceutical Industry In INDIA-2011
pros & cons Of Pharmaceutical Industry In INDIA-2011pros & cons Of Pharmaceutical Industry In INDIA-2011
pros & cons Of Pharmaceutical Industry In INDIA-2011
 
DRUG PRICE CONTROLE ORDER OR NATIONAL PHARMACEUTICAL PRICING AUTHORITY
DRUG PRICE CONTROLE ORDER OR NATIONAL PHARMACEUTICAL PRICING AUTHORITYDRUG PRICE CONTROLE ORDER OR NATIONAL PHARMACEUTICAL PRICING AUTHORITY
DRUG PRICE CONTROLE ORDER OR NATIONAL PHARMACEUTICAL PRICING AUTHORITY
 
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
REGULATORY AFFAIRS ( IP-2 / UNIT 3 )
 
National Pharmaceutical Pricing Authority
National Pharmaceutical Pricing AuthorityNational Pharmaceutical Pricing Authority
National Pharmaceutical Pricing Authority
 

More from Chandigarh College of Pharmacy (13)

Drug export rule trims gatt sadc wto
Drug export rule trims gatt sadc wtoDrug export rule trims gatt sadc wto
Drug export rule trims gatt sadc wto
 
Biochemical analysis techniques
Biochemical analysis techniquesBiochemical analysis techniques
Biochemical analysis techniques
 
Bioassay
BioassayBioassay
Bioassay
 
Solublity detemination
Solublity deteminationSolublity detemination
Solublity detemination
 
Tabletnproduction and coating system
Tabletnproduction and coating systemTabletnproduction and coating system
Tabletnproduction and coating system
 
Disolution best
Disolution bestDisolution best
Disolution best
 
TRIPS
TRIPSTRIPS
TRIPS
 
ISO 9000 pdf
ISO 9000 pdfISO 9000 pdf
ISO 9000 pdf
 
GCP ppdf
GCP ppdfGCP ppdf
GCP ppdf
 
Drug Regulatory Affairs pdf
Drug Regulatory Affairs pdfDrug Regulatory Affairs pdf
Drug Regulatory Affairs pdf
 
Bio burden
Bio burdenBio burden
Bio burden
 
Industrial hazard pdf
Industrial hazard pdfIndustrial hazard pdf
Industrial hazard pdf
 
Pharmacovigilance pdf
Pharmacovigilance pdfPharmacovigilance pdf
Pharmacovigilance pdf
 

Recently uploaded

Fundamentals Welcome and Inclusive DEIB
Fundamentals Welcome and  Inclusive DEIBFundamentals Welcome and  Inclusive DEIB
Fundamentals Welcome and Inclusive DEIBGregory DeShields
 
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...ssuserf63bd7
 
WSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfWSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfJamesConcepcion7
 
MEP Plans in Construction of Building and Industrial Projects 2024
MEP Plans in Construction of Building and Industrial Projects 2024MEP Plans in Construction of Building and Industrial Projects 2024
MEP Plans in Construction of Building and Industrial Projects 2024Chandresh Chudasama
 
Rakhi sets symbolizing the bond of love.pptx
Rakhi sets symbolizing the bond of love.pptxRakhi sets symbolizing the bond of love.pptx
Rakhi sets symbolizing the bond of love.pptxRakhi Bazaar
 
digital marketing , introduction of digital marketing
digital marketing , introduction of digital marketingdigital marketing , introduction of digital marketing
digital marketing , introduction of digital marketingrajputmeenakshi733
 
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...Hector Del Castillo, CPM, CPMM
 
Roman Kyslyi: Використання та побудова LLM агентів (UA)
Roman Kyslyi: Використання та побудова LLM агентів (UA)Roman Kyslyi: Використання та побудова LLM агентів (UA)
Roman Kyslyi: Використання та побудова LLM агентів (UA)Lviv Startup Club
 
Implementing Exponential Accelerators.pptx
Implementing Exponential Accelerators.pptxImplementing Exponential Accelerators.pptx
Implementing Exponential Accelerators.pptxRich Reba
 
Interoperability and ecosystems: Assembling the industrial metaverse
Interoperability and ecosystems:  Assembling the industrial metaverseInteroperability and ecosystems:  Assembling the industrial metaverse
Interoperability and ecosystems: Assembling the industrial metaverseSiemens
 
NAB Show Exhibitor List 2024 - Exhibitors Data
NAB Show Exhibitor List 2024 - Exhibitors DataNAB Show Exhibitor List 2024 - Exhibitors Data
NAB Show Exhibitor List 2024 - Exhibitors DataExhibitors Data
 
Planetary and Vedic Yagyas Bring Positive Impacts in Life
Planetary and Vedic Yagyas Bring Positive Impacts in LifePlanetary and Vedic Yagyas Bring Positive Impacts in Life
Planetary and Vedic Yagyas Bring Positive Impacts in LifeBhavana Pujan Kendra
 
5-Step Framework to Convert Any Business into a Wealth Generation Machine.pdf
5-Step Framework to Convert Any Business into a Wealth Generation Machine.pdf5-Step Framework to Convert Any Business into a Wealth Generation Machine.pdf
5-Step Framework to Convert Any Business into a Wealth Generation Machine.pdfSherl Simon
 
Healthcare Feb. & Mar. Healthcare Newsletter
Healthcare Feb. & Mar. Healthcare NewsletterHealthcare Feb. & Mar. Healthcare Newsletter
Healthcare Feb. & Mar. Healthcare NewsletterJamesConcepcion7
 
Data Analytics Strategy Toolkit and Templates
Data Analytics Strategy Toolkit and TemplatesData Analytics Strategy Toolkit and Templates
Data Analytics Strategy Toolkit and TemplatesAurelien Domont, MBA
 
Darshan Hiranandani (Son of Niranjan Hiranandani).pdf
Darshan Hiranandani (Son of Niranjan Hiranandani).pdfDarshan Hiranandani (Son of Niranjan Hiranandani).pdf
Darshan Hiranandani (Son of Niranjan Hiranandani).pdfShashank Mehta
 
1911 Gold Corporate Presentation Apr 2024.pdf
1911 Gold Corporate Presentation Apr 2024.pdf1911 Gold Corporate Presentation Apr 2024.pdf
1911 Gold Corporate Presentation Apr 2024.pdfShaun Heinrichs
 
Types of Cyberattacks - ASG I.T. Consulting.pdf
Types of Cyberattacks - ASG I.T. Consulting.pdfTypes of Cyberattacks - ASG I.T. Consulting.pdf
Types of Cyberattacks - ASG I.T. Consulting.pdfASGITConsulting
 
Exploring Elite Translation Services in Your Vicinity
Exploring Elite Translation Services in Your VicinityExploring Elite Translation Services in Your Vicinity
Exploring Elite Translation Services in Your VicinityThe Spanish Group
 
trending-flavors-and-ingredients-in-salty-snacks-us-2024_Redacted-V2.pdf
trending-flavors-and-ingredients-in-salty-snacks-us-2024_Redacted-V2.pdftrending-flavors-and-ingredients-in-salty-snacks-us-2024_Redacted-V2.pdf
trending-flavors-and-ingredients-in-salty-snacks-us-2024_Redacted-V2.pdfMintel Group
 

Recently uploaded (20)

Fundamentals Welcome and Inclusive DEIB
Fundamentals Welcome and  Inclusive DEIBFundamentals Welcome and  Inclusive DEIB
Fundamentals Welcome and Inclusive DEIB
 
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
Intermediate Accounting, Volume 2, 13th Canadian Edition by Donald E. Kieso t...
 
WSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdfWSMM Technology February.March Newsletter_vF.pdf
WSMM Technology February.March Newsletter_vF.pdf
 
MEP Plans in Construction of Building and Industrial Projects 2024
MEP Plans in Construction of Building and Industrial Projects 2024MEP Plans in Construction of Building and Industrial Projects 2024
MEP Plans in Construction of Building and Industrial Projects 2024
 
Rakhi sets symbolizing the bond of love.pptx
Rakhi sets symbolizing the bond of love.pptxRakhi sets symbolizing the bond of love.pptx
Rakhi sets symbolizing the bond of love.pptx
 
digital marketing , introduction of digital marketing
digital marketing , introduction of digital marketingdigital marketing , introduction of digital marketing
digital marketing , introduction of digital marketing
 
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
How Generative AI Is Transforming Your Business | Byond Growth Insights | Apr...
 
Roman Kyslyi: Використання та побудова LLM агентів (UA)
Roman Kyslyi: Використання та побудова LLM агентів (UA)Roman Kyslyi: Використання та побудова LLM агентів (UA)
Roman Kyslyi: Використання та побудова LLM агентів (UA)
 
Implementing Exponential Accelerators.pptx
Implementing Exponential Accelerators.pptxImplementing Exponential Accelerators.pptx
Implementing Exponential Accelerators.pptx
 
Interoperability and ecosystems: Assembling the industrial metaverse
Interoperability and ecosystems:  Assembling the industrial metaverseInteroperability and ecosystems:  Assembling the industrial metaverse
Interoperability and ecosystems: Assembling the industrial metaverse
 
NAB Show Exhibitor List 2024 - Exhibitors Data
NAB Show Exhibitor List 2024 - Exhibitors DataNAB Show Exhibitor List 2024 - Exhibitors Data
NAB Show Exhibitor List 2024 - Exhibitors Data
 
Planetary and Vedic Yagyas Bring Positive Impacts in Life
Planetary and Vedic Yagyas Bring Positive Impacts in LifePlanetary and Vedic Yagyas Bring Positive Impacts in Life
Planetary and Vedic Yagyas Bring Positive Impacts in Life
 
5-Step Framework to Convert Any Business into a Wealth Generation Machine.pdf
5-Step Framework to Convert Any Business into a Wealth Generation Machine.pdf5-Step Framework to Convert Any Business into a Wealth Generation Machine.pdf
5-Step Framework to Convert Any Business into a Wealth Generation Machine.pdf
 
Healthcare Feb. & Mar. Healthcare Newsletter
Healthcare Feb. & Mar. Healthcare NewsletterHealthcare Feb. & Mar. Healthcare Newsletter
Healthcare Feb. & Mar. Healthcare Newsletter
 
Data Analytics Strategy Toolkit and Templates
Data Analytics Strategy Toolkit and TemplatesData Analytics Strategy Toolkit and Templates
Data Analytics Strategy Toolkit and Templates
 
Darshan Hiranandani (Son of Niranjan Hiranandani).pdf
Darshan Hiranandani (Son of Niranjan Hiranandani).pdfDarshan Hiranandani (Son of Niranjan Hiranandani).pdf
Darshan Hiranandani (Son of Niranjan Hiranandani).pdf
 
1911 Gold Corporate Presentation Apr 2024.pdf
1911 Gold Corporate Presentation Apr 2024.pdf1911 Gold Corporate Presentation Apr 2024.pdf
1911 Gold Corporate Presentation Apr 2024.pdf
 
Types of Cyberattacks - ASG I.T. Consulting.pdf
Types of Cyberattacks - ASG I.T. Consulting.pdfTypes of Cyberattacks - ASG I.T. Consulting.pdf
Types of Cyberattacks - ASG I.T. Consulting.pdf
 
Exploring Elite Translation Services in Your Vicinity
Exploring Elite Translation Services in Your VicinityExploring Elite Translation Services in Your Vicinity
Exploring Elite Translation Services in Your Vicinity
 
trending-flavors-and-ingredients-in-salty-snacks-us-2024_Redacted-V2.pdf
trending-flavors-and-ingredients-in-salty-snacks-us-2024_Redacted-V2.pdftrending-flavors-and-ingredients-in-salty-snacks-us-2024_Redacted-V2.pdf
trending-flavors-and-ingredients-in-salty-snacks-us-2024_Redacted-V2.pdf
 

Drug price pdf

  • 1. Compiled by-Shamon Ahmad, M.Pharma (Q.A) Chandigarh Group of Colleges, Landran, Mohali(Punjab India)email-shmmon@gmail.com on Date-25/12/2012 Drugs Price Control Order (DPCO) 1995 The Drugs Price Control Order (DPCO), 1995 is an order issued by the Government of India under Section 3 of the Essential Commodities Act, 1955 to regulate the prices of drugs. The Order inter alia provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by Government and penalties for contravention of provisions among other things. Drugs and formulations have been subjected to price control for more than three decades now. The economic reforms initiated by the Government of India in July 1991, trickled down to the Pharmaceutical Industry only in 1994 and that too partially. Price control in a large number of industries has already been abolished. Objectives of Drug Policy As per the changes in Drug Policy, 1986 announced in September, 1994, the main objectives of the Drug Policy are as under : • • • • Providing abundant quanity, at reasonable prices of essential and life saving and medicines of good quality. Strengthening the quality control system over drugs and medicies production and promoting the rational use of drugs in the country. Creating an environment friendly to channelising new investment into the pharmaceutical industry with an objective to boost cost-effective production with economic sizes and introducing new technologies and new drugs. Strengthening the indigenous capability for production of drugs. About NPPA For the purpose of implementing provisions of DPCO, powers of the Government have been vested in the National Pharmaceutical Pricing Authority (NPPA). Drugs are essential for health of the society. Drugs have been declared as essential and accordingly put under the Essential Commodities Act. Only 74 out of 500 commonly used bulk drugs are kept under statutory price control. All formulations containing these bulk drugs either in a single or combination form fall under the price control category. However, the prices of other drugs can be regulated, if warranted in public interest. The NPPA was established on 29th August 1997 as an independent body of experts following the Cabinet Committee’s decision in September 1994 while reviewing the Drug Policy. The Authority, inter alia, has been entrusted with the task of fixation/revision of prices of pharmaceutical products (bulk drugs and formulations), enforcement of provisions of the Drugs (Prices Control) Order and monitoring the prices of controlled and decontrolled drugs in the country. Features of DPCO;
  • 2. The essentail features of DPCO covers the following questions: • • • • • • How are the prices of drugs and medicines in the controlled category regulated? There are two prices for this fixed by the NPPA as per the provisions of DPCO Ceiling and DPCONon Ceiling Price . Ceiling Price is the single maximum selling price fixed that is applicable throughout the country in the case of each bulk drug, which is under price control. Non-Ceiling Price fixed by NPPA are specific to a particular pack size of scheduled Ceiling formulation of a particular company. Whether NPPA has any role to regulate prices of non-scheduled drugs (drugs not under non scheduled direct price control)? What margins are allowed to a Wholesaler and a Retailer as per DPCO, 1995? FORM OF APPLICATION FOR APPROVAL OR REVISION OF PRICE OF SCHEDULED FORMULATIONS. 1. Name of the Formulation. 2. Name of the Manufacturer. 3. Address of Registered/Head Office/ Administrative Office. 4. Address of the Factory. 5. Composition as per label claim and approved by Drug Control Authorities. 6. Drug Control Authority Permission Number and Date (copy to be enclosed). (copy 7. Number and date of Industrial Licence/Small Scale Industry Registration/ Industrial Entrepreneure Memorandum acknowledgement (copy to be enclosed). 8. Date of Commencement of Production. 9. Type of formulation: • • • Type [Plain/ Coated Tablets, Multi layered sustained release/ Soft/ Hard/ Printed Multi-layered capsules (without/ with/ sealing band) / sterile/ non-sterile Liquid/ Powder/ Ointment/ non sterile Cream etc.]; In case of Tablets please furnish average weight of 100 Tablets; In case of Capsules please furnish size of capsule. e 10. Type of packing [Aluminium/ Paper/ Cellophane/ Strips/ Blister/ Vials/ Ampoules/ White Colour Bottles/ Tins/ Jars/ with/ without dropper/ cutting blades/ catch cover etc.]. 11. Size of packs [10's/ 100's/ etc; 1ml/ 2ml/ 10 ml/ etc.; 5 gms/ 10 gms/ etc.]., 12. Number of Packs sold during the last accounting year and details of other packs of the same formulation with their retail prices.
  • 3. 13. Break-up of Retail Price :Details Existing Price if any* (Rs./Pack) Now Claimed (Rs./Pack) (a) Material Cost (as per S.No. 14d); (b) Conversion Cost (as per norms); (c) Packing Material Costs (as per S.No. 15 or as per norms); (d) Packing Charges; (e) Ex-factory Cost (a to d); (f) MAPE 100% on (e) above; (g) Excise Duty; (h) Retail Price (R.P.) (e+f+g). * Existing Retail Price Approval Letter No. and Date - copy to be enclosed. 14. Material Cost • • • Batch Size (Nos./Litres/Kgs./etc); No. of packs that can be theoretically obtained from the batch size as in (a) above; Material Cost for the batch size as in (a) above; S.No. Name of the Material Unit Theoretical Quantity Actual Total Overages (4+5) Quantity Rate/Unit Cost for the Batch(6 x 7) (1) (3) (4) (5) (7) (2) Imported 1. 2. 3. etc. Indigenous 1. 2. 3. etc. Total ................................................... : Add: Process loss as per norms ..............% : Total Material Cost ................................. : Total Material Cost Material Cost per Pack = ----------------------------- (6) (8)
  • 4. Theoretical No. of Packs 15. Packing Material Costs:Packs of ....................................... Batch Size : ..................... Tablets/Gms/etc. each S.No. Name of the Packing Material Unit Rate per Unit (Rs.) Qty. Required per Batch Value of Packing Materials/Batch (Nos/Kgs etc)(Rs.) (1) (2) (3) (5) (6) (4) Imported 1. 2. 3. etc. Indigenous 1. 2. 3. etc. Total ................................................... : Add: Process loss as per norms ..............% : Total Packing Material Cost ................................. : Total Packing Material Cost Packing Material Cost per Pack = ----------------------------------------No. of Packs as per Batch size