The document discusses India's Drug Price Control Order (DPCO) which allows the government to regulate prices of essential drugs. The objectives of the DPCO are to ensure adequate production and supply of drugs at fair prices through equal distribution. It defines key terms like bulk drugs, formulations, and ceiling prices. The DPCO specifies how maximum retail prices are calculated and requires manufacturers to provide drug cost information to the government annually. It also outlines penalties for violating the order, such as increasing prices without approval or selling drugs in unlabeled split quantities.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
National pharmaceutical pricing authority with drugs price control order (dpc...Tushar Morankar
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified
strengths and dosages under NLEM 2011.
Main Features of the DPCO 2013
• The new order will bring 348 drugs & their 652 formulations under price control.
• The new policy uses a market-based pricing mechanism against the earlier proposed cost-plus method. The ceiling price would be calculated by taking the simple average of prices of all brands of a drug with a market share of 1% or more.
This presentation is related to the drug price control order in India. It will give an idea to the readers how the prices have been fixed for the formulations. How the price has been calculated for scheduled formulations.
This act gives an idea about the constitution and functions of PCI. Brief about Education Regulation in India. Registration procedure for the pharmacist in India.
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified strengths and dosages under NLEM 2011.
National pharmaceutical pricing authority with drugs price control order (dpc...Tushar Morankar
The government has notified the DPCO 2013 under the Essential Commodities Act, 1955, which will give power to the NPPA (National Pharmaceutical Pricing Authority (NPPA )to regulate prices of 348 essential drugs along with their specified
strengths and dosages under NLEM 2011.
Main Features of the DPCO 2013
• The new order will bring 348 drugs & their 652 formulations under price control.
• The new policy uses a market-based pricing mechanism against the earlier proposed cost-plus method. The ceiling price would be calculated by taking the simple average of prices of all brands of a drug with a market share of 1% or more.
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These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
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-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
The drug price control order (DPCO) is an order issued by
the government under the Essential Commodities Act which
enables it to fix the prices of some essential bulk drugs and
their formulations
The origin of this control dates back to 1970 when for the
first time the government placed limits on profitability of
pharmaceutical companies.
Drugs and Magic Remedies (Objectionable Advertisements), 1954 Act,1954 Sagar Savale
An Act to control the advertisement of drugs in certain cases, to prohibit the advertisement for certain purposes of remedies alleged to possess magic qualities and to provide for matters connected therewith. This act is not unconstitutional, because it does not interferes with private business and also it does not impose unreasonable restrictions.
Medicinal and toilet preparations act and rules,1955Ganesh Shevalkar
It is an Act with provision for levy and collection of excise duties on medicinal and toilet preparations containing alcohol, opium, Indian hemp (cannabis) or other narcotic drugs.
These presentation describes the rules and regulations for the manufacture of drugs and grant of license. Loan License and Repacking License is also described. These presentation is the part of series Drugs & Cosmetics Act.
State pharmacy council and joint state pharmacy council:
Under the Pharmacy Act each Sate Govt. is required to constitute a state pharmacy council for the maintenance of register of Pharmacists of the State and to monitor their professional activities.
Two or more states can also enter into an agreement to form a Joint State Pharmacy Council.
At the end of the 19th century and early 20 century use of Allopathy system increases
Drugs of natural origin: Veg, mineral oil and animals
At that time, profit became main motive than service
Overdose of quinine.A Central law to control drugs and pharmacy profession.
The prevention of cruelty to animals act 1960Shaik Rasheed
This presentation give the complete information regarding the The Prevention of Cruelty to Animals Act 1960 including the definitions, composition of IAEC, Breeding and stocking of animals, experiments, offences and penalties.
A presentation aimed at providing information with regards to the Pharmacy Act, 1948.
-INTRODUCTION
-HISTORY OF THE ACT
-PHARMACY COUNCIL OF INDIA
-STATE PHARMACY COUNCIL
-SPECIAL PROVISIONS OF THE ACT
-OFFENCES AND PENALTIES
-CONCLUSION
-REFERENCES
The drug price control order (DPCO) is an order issued by
the government under the Essential Commodities Act which
enables it to fix the prices of some essential bulk drugs and
their formulations
The origin of this control dates back to 1970 when for the
first time the government placed limits on profitability of
pharmaceutical companies.
NPPA is an organization of the Government of India which was established, inter alia, to fix/ revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country, under the Drugs (Prices Control) Order, 1995. The organization is also entrusted with the task of recovering amounts overcharged by manufacturers for the controlled drugs from the consumers. It also monitors the prices of decontrolled drugs in order to keep them at reasonable levels.
Drug Price Control Orders (DPCO) are issued by the Government, in exercise of the powers conferred under section 3 of the Essential Commodities Act, 1955, for enabling the Government to declare a ceiling price for essential and life saving medicines (as per a prescribed formula) so as to ensure that these medicines are available at a reasonable price to the general public. The latest Drug Price Control Order (DPCO-2013) was issued on 15.05.2013.
Price controls are applicable to what is generally known as “Scheduled drugs” or “Scheduled formulations” that is, those medicines which are listed out in the Schedule I of Drug Price Control Order (DPCO), issued by the Government of India from time to time[1]. (It may be noted that the use of the word “Scheduled drugs” is a legacy of the DPCO-1995[2]. The latest DPCO 2013 only uses the word “Scheduled formulation” to refer to medicines in its first schedule since some of the bulk drugs when used as a single ingredient also act as a formulation. Hence, generally these medicines are referred even now as “scheduled drugs” from the perspective of price regulation). Since 2013, scheduled formulations consist of the “Essential Medicines” declared so by the Government through its National List of Essential Medicines (NLEM)[3]. In fact, Schedule I of DPCO-2013 is the NLEM-2011 list. Thus, NLEM forms the basis of deciding which medicines should come under price control via DPCO. Any formulation based on combination of any one of these drugs appearing under NLEM can be subject to price fixation. In the earlier DPCOs (those prior to DPCO-2013), NLEM was not taken into consideration for price fixation or price monitoring[4]. Further, in the earlier DPCOs, only the bulk drugs were mentioned in Schedule-I[5] and prices wfixed by the Government for both bulk drug as well as formulations based on any of these bulk drugs.
All matters relating to NPPA including its functions of price control and monitoring.
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Policy 2002,and National List of Essential Medicines (NLEM).
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...Dr. Ambekar Abdul Wahid
Introduction to NPPA, The Drug Regulatory System in India, NPPA Activities and Responsibility's, Function and Organization of NPPA, Introduction to DPCO 2013, Salient features of DPCO 2013, Prices of Bulk Drug, Retail price of Formulations, Pricing of Scheduled Formulations, Various Schedules related to DPCO Act and Amendments.
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1. DRUG AND PRICE CONTROL
ORDER
SAJAL KUMAR CHOWDHURY
B.PHARM
4TH YEAR
2. INTRODUCTION
The drug price control order (DPCO) is an order issued by
the government under the Essential Commodities Act which
enables it to fix the prices of some essential bulk drugs and
their formulations
The origin of this control dates back to 1970 when for the
first time the government placed limits on profitability of
pharmaceutical companies.
3. OBJECTIVES
To achieve adequate production
To regulate equal distribution
To maintain and increase supply of bulk drugs and formulations
To make these available at fair prices.
4. DEFINATION
BULK DRUGS:-
It means any pharmaceutical, chemical and biological or plant product conforming
to pharmacopoeia standards specified in D & C Act, 1940.
CEILING PRICE:-
Price fixed by government for scheduled formulation.
FORMULATION:-
Medicine processed out or containing one or more bulk drugs with/without
pharmaceutical aid for internal/external use for/in diagnosis, treatment, mitigation
or prevention of disease in human/animals.(not include ayurvedic, sidhha , unani ,
tibbi and homeopathic system of medicine.)
5. DRUGS:-
Substance intended to be used for or in the diagnosis, treatment, or prevention of
any disease or disorder in human or animal.
RETAIL PRICE:-
Retail price of drugs fixed in accordance with previsions of DPCO 1995 and
include celling price.
SCHDULED/NOSCHEDULED BULK DRUGS:-
It means bulk drugs specified/not specified in first schedule.
Distributor, dealer, retailer, wholesaler, pre tax return, sale turnover.
6. PRICE OF BLUCK DRUGS
Government has power to fix the maximum sale price.
While fixing the sale price government shall take into following considerations:-
Post-tax return of 14% on net worth.
Return of 22%on capital employed.
On the basic stage of production, post tax return of 18% on net worth or26% on
capital employed.
15 days for new bulk drug production
Manufacturer fill detail in from-1 for revision of sale price and government will
respond within 4 months.
Manufacture will submit information in form I and II with in 30 days`
7. INFORMATION REQUIRED FROM
MANUFACTURER TO THE GOVERNMENT
For the both scheduled and non-scheduled bulk drugs
List of drugs produced with cost in form 1 and 2
respectively.
But for scheduled bulk drugs it should given by 30th
September every year
8. RETAIL PRICE OF FORMULATION
Formula for calculation:--
R.P= (M.C+C.C+P.M+P.C.) x (1+ MAPE/100)+ED.
Where, R.P= Retail price
M.C= material cost
C.C= conversion cost
P.M= packaging material cost
P.C= packing charges
E.D= excise duty
MAPE= maximum allowable post manufacturing expenses
9. WITHOUT APROVAL OF
GOVERNMENT
Manufacturer should not increased retail price of
drug.
Manufacturer should not marketed new
formulation.
No person shall sell imported scheduled
formulation.
10. CONTROL OF SALE PRICES OF
BULK DRUG AND FORMULATION
No person or retailer shall sale the drug /
formulation to any customer at increasing price
specified In current price list indicated on container
label.
11. SALE OF SPLIT QUANTITY OF
FORMULATION
No dealer shall sell the loose quantity of formulation
At price exceeding pro –rata prices of formulation plus 5%.
12. OFFENCES OF PENALTIES
Shall be punishable with imprisonment for one year and
also liable to find
In the case of any other order with imprisonment for not
less than three months but which may extend to seven
years and also liable to fine.
Retail price not to exceed or local taxes extra
13. REFENCES
A text book of Forensic Pharmacy , B.M. Mithal, Vallabh
Prakashan, page no 172 to 176.
Forensic Pharmacy, B.S Kuchekar, A.M Khadatare, S.C
Itkar, Nirali Prakashan 3.1 to 3.18
http://seednet.gov.in/material/Essentail_Commodity_Act_19
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