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.
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.
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.
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.
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.
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.
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.
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.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
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.
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.
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.
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.
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.
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.
Codes of pharmaceutical ethics
In relation to his trade
In relation to his Job
In relation to his Profession
In relation to Medical Profession
Pharmacist's Oath
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.
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.
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.
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.
All matters relating to NPPA including its functions of price control and monitoring.
Responsible for development of infrastructure, manpower and skills for the pharmaceutical sector.
Work for the promotion and coordination of basic, applied and other research in areas related to the pharmaceutical sector and for international co-operation in pharmaceutical research.
this presentation deals with drug price control in India. it has also updated information on drug price regulation. any suggestion regarding this topic is most welcomed.
National Pharmaceutical Pricing AuthorityP.N.DESHMUKH
National Pharmaceutical Pricing Authority established by the central government on dated 29 th August 1997 as an independent, autonomous regulator.
Drugs Price Control Order,2013 explained Retail Prices of a scheduled Formulation,Ceiling price of a scheduled formulation,Pharmaceutical
Policy 2002,and National List of Essential Medicines (NLEM).
India is the land of spiritualist of babas and sadhus. There has not been a law specifically to prosecute those making false spiritual claims and deceive people.
A condition in which the heart is unable to pump sufficient blood
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Cell cycle and Regulation
* cell Division is occur in every human but these have certaint check point to preventing from the forming the defective cell or cancerious cell.
Trabactine : A Lead for Anti-cancer
Abstract:
Marine secondary metabolites are a promising source of unexploited drugs that have a wide
structural diversity and have shown a variety of biological activities. These compounds are
produced in response to the harsh and competitive conditions that occur in the marine
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or clinical stages, from diverse organisms that were reported as being active or potentially
active in cancer treatment in the past seventeen years (from January 2000 until April 2017)
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and reveals that classical approaches for the selection of drug candidates based on ADMET
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anticancer lead compounds. Finally, we introduce a novel and publically accessible chemical
library of MNPs for virtual screening purposes.
Keywords: marine natural product; invertebrate; cancer; virtual screeni in trabactine
1.Patients have poor or no knowledge of the price variations among branded and generic medicines, and leave the choice of the medicine to the doctor.
2.The government must take up generic promotional schemes, general awareness programs on quality of generics to build confidence among prescribers, pharmacists, and consumers.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
A Strategic Approach: GenAI in EducationPeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
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Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
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Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
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The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
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National pharmaceutical pricing authority with drugs price control order (dpco)2013
1. 1
Seminar on
DRUG (PRICE CONTROL) ORDER ACT, 1995
PRESENTED BY-
Tushar D. Morankar.
(T.Y.B.Pharm)
Guided By-
K.D.Mali Sir
Mr.Tushar D Morankar
2. 2
CONTENT
Introduction
History
Amendments
Objectives
Definitions
Prices of bulk drugs
Information required from manufacturer to the government
Retail price of formulation
Powers to fix price of scheduled formulation
Mr.Tushar D Morankar
3. 3
Cont.…….
Fixation of price under certain circumstances
Power to recover overcharged amount
Control of sale prices of bulk drug and formulation
Sale of split quantity of formulation.
Schedules related with DPCO Act, 1995.
Offences and penalties.
References.
Mr.Tushar D Morankar
4. 4
DRUG -
A substance intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease.
PRICE-
The amount of money given or set as consideration for the sale of a specified thing.
CONTROL-
To exercise restraining or directing influence over.
ORDER-
An authoritative command, direction, or instruction
INTRODUCTION
Mr.Tushar D Morankar
5. 5
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.
Continue….
Mr.Tushar D Morankar
6. 6
DPCO ACT, 2013
DPCO ACT, 1995
Confirmed by Section 3 of
Essential Commodities Act, 1955.
Mr.Tushar D Morankar
7. 7
HISTORY
In 1966, parliament members felt that
manufacturers charging high rate on drugs.
To control on high drug rates,
DPCO Act 1966 was passed under Section 3 of Essential
Commodities Act 1955.
Mr.Tushar D Morankar
8. 8
DPCO Act, 1966 replaced by DPCO Act, 1970.
In 1974, Hathi Committee was formed and
submitted it’s reports in 1975.
DPCO Act, 1970 replaced by DPCO Act, 1987.
DPCO Act, 1987 replaced by DPCO Act, 1995.
Finally DPCO Act, 1995 replaced by DPCO Act, 2013.
Mr.Tushar D Morankar
9. 9
AMMENDMENTS
Drug Price Control Order, 1970
Drug Price Control Order, 1979
Drug Price Control Order, 1987
Drug Price Control Order, 1991
Drug Price Control Order, 1995
Drug Price Control Order, 2013
Mr.Tushar D Morankar
12. 12
OBJECTIVES
To Achieve Adequate Production
To regulate Equal Distribution
To Maintain and Increase Supply Of Bulk Drugs
To make at Fair Prices.
Mr.Tushar D Morankar
13. 13
DPCO 2013
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.
Mr.Tushar D Morankar
14. 14
• Margins of wholesalers & retailers have been cut down to
8% & 16% respectively.
• Monitoring the M.R.P of Non-Scheduled formulation.
• Control over Bulk Drug manufacturer.
• Control over Formulation manufacturer
• Drug producers will be permitted an annual increase in
the retail price in sync with the wholesale price index.
Mr.Tushar D Morankar
15. 15
To implement and enforce the provisions of the Drugs (Prices Control) Order
in accordance with the powers delegated to it.
To deal with all legal matters arising out of the decisions of the Authority.
To monitor the availability of drugs, identify shortages, if any, and to take
remedial steps.
To collect/ maintain data on production, exports and imports, market share of
individual companies, profitability of companies etc, for bulk drugs and
formulations.
To undertake and/ or sponsor relevant studies in respect of pricing of drugs/
pharmaceuticals.
To recruit/ appoint the officers and other staff members of the Authority, as per
rules and procedures laid down by the Government.
To render advice to the Central Government on changes/ revisions in the drug
policy.
To render assistance to the Central Government in the parliamentary matters
relating to the drug pricing
FUNCTIONS….
Mr.Tushar D Morankar
16. 16
DEFINITIONS
BULK DRUGS :-
It means any pharmaceutical, chemical and biological or plant product
conform to pharmacopoeial standards specified in D And C Act, 1940.
CEILING PRICE:-
Price Fixed By Government For Scheduled Formulation.
Mr.Tushar D Morankar
17. 17
DRUG :-
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 drug fixed in accordance with provisions of DPCO 1995 and
include ceiling price.
SCHEDULED BULK DRUG :-
It Means Bulk Drug Specified In First Schedule.
Mr.Tushar D Morankar
18. 18
PRICES OF BULK DRUGS
Government has power to fix the maximum sale price.
A) 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.
For new plant, return of 12% based on long term marginal cost.
On the basic stage of production, post tax return of 18% on net worth or 26% on capital
employed.
Mr.Tushar D Morankar
19. 19
PRICES OF BULK DRUGS
B) At the time of production of drug, manufacturer fill detail in FORM-I and give
necessary information to government within 15 days.
C) Make necessary inquiry and then government fix maximum sale price of bulk
drug and noted in official gazette.
D) Gov. Also fix or revise the price of non-scheduled bulk drugs.
Mr.Tushar D Morankar
20. 20
Information Required From Manufacturer to The Government
For the both Scheduled and Non-scheduled bulk drugs
List of drug produced with cost in FORM 1 and FORM 2 resp.
But for scheduled bulk drugs it should given by 30 September every year.
Mr.Tushar D Morankar
21. 21
RETAIL PRICE OF FORMULATION
CALCULATION :-
FORMULA :
Where, R.P. = Retail Price
M.C.= Material Cost
C.C.= Conversion Cost
P.M.= Packaging Material Cost
P.C.= Packing Charges
MAPE= Maximum Allowable Post Manufacturing Expenses
ED = Excise Duty
Mr.Tushar D Morankar
22. 22
POWER TO FIX RETAIL PRICE OF SCHEDULED FORMULATION
Government fix the Retail Price Of Bulk Drug.
And manufacturer use drugs in scheduled formulation.
For price revision of such formulation manufacturer should apply within 30
days.
From Date Of Receipt of complete information Govr. Fix Retail Price within 2
months.
Mr.Tushar D Morankar
23. 23
No Person Shall Sell Imported Scheduled Formulation.
Manufacturer Should Not Marketed New Formulation.
Manufacturer Should Not Increase Retail Price Of Drug.
Without Approval Of Government,
Mr.Tushar D Morankar
24. 24
POWER TO FIX CEILING PRICE OF SCHEDULED FORMULATION
Government fix the Ceiling Price of Scheduled Formulation with formula
given in the Paragraph 7 keep cost and efficiency or both.
Ceiling Price for formulation including those sold under GENERIC NAME.
Fixed Revised Ceiling Price for Schedule Formulation either on it’s own
motion or on application made in prescribed form.
Mr.Tushar D Morankar
25. 25
PRICING OF SCHEDULED FORMULATION
The ceiling price of a scheduled formulation of specified strengths and dosages as
specified under the first schedule shall be calculated as under:
• Step I: First the Average Price to Retailer of the scheduled formulation i.e. P(s) shall
be calculated as below:
Average Price to Retailer
P(s) = (Sum of prices to retailer of all the brands and generic versions of the medicine having market share
more than or equal to one percent of the total market turnover) / (Total number of such brands and generic
versions of the medicine having market share more than or equal to one percent of total market turnover on the
basis of moving annual turnover for that medicine.)
Mr.Tushar D Morankar
26. 26
• Step II. Thereafter, the ceiling price of the scheduled formulation i.e. P(c) shall be
calculated as below:
P(c) = P(s).(1+M/100), where
P(s) = Average Price to Retailer for the same strength and dosage
of the medicine as calculated in step1 above.
M = % Margin to retailer and its value =16
Margin to retailer: While fixing a ceiling price of scheduled formulations and retail
prices of new drugs, sixteen percent of price to retailer as a margin to retailer shall be
allowed.
Mr.Tushar D Morankar
27. 27
Maximum retail price:
(1)The maximum retail price of scheduled formulations shall be fixed by the
manufacturers on the basis of ceiling price notified by the Government plus local taxes
wherever applicable, as under:
Maximum Retail Price = Ceiling price + Local Taxes as applicable
(2)The maximum retail price of a new drug shall be fixed by the manufacturers on the
basis of retail price determined by the Government plus local taxes wherever
applicable, as under:
Maximum Retail Price = Retail Price + Local Taxes as applicable
Mr.Tushar D Morankar
28. 28
POWER TO REVISE PRICE OF BULK DRUG AND FORMULATION
Government Fix or Revise Retail Price of One or more Formulation.
As the Pre-Tax Return on Sales Turnover of Formulation then the
Scheduled and Non-scheduled Formulation.
Mr.Tushar D Morankar
29. 29
FIXATION OF PRICE UNDER CERTAIN CIRCUMSTANCES
If any Manufacturer of Bulk Drug Fails to Submit the Application For Fixation
or Revision of Price or Fails to give Information Within Specified time period.
Then Government Fix Price of the Bulk Drug.
Mr.Tushar D Morankar
30. 30
POWER TO RECOVER OVERCHARGED AMOUNT
If any manufacturer or importer charging higher price than
the price fixed by government
Then government may recover the overcharged amount.
Mr.Tushar D Morankar
31. 31
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.
Mr.Tushar D Morankar
32. 32
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%.
Mr.Tushar D Morankar
33. 33
SCHEDULES RELATED WITH DPCO ACT, 1995
FIRST SCHEDULE
First Schedule Includes 76 Bulk Drugs.
E.g. Penicillin, Ranitidine, Chloroquine Etc.
Mr.Tushar D Morankar
34. 34
SECOND SCHEDULE
Different Forms Included :-
FORM- I :- Application For Fixation/ Revision Of Price.
FORM- II :- Information Related With Price Of Non-scheduled Bulk Drug.
FORM-III:- Application For Approval/Revision Of Price Of Scheduled Formulation.
FORM-IV :- Application For Approval/Revision Of Price Of Scheduled Formulation
imported In Finished Form.
FORM-V :- Form Of Price List
FORM- VI :- Yearly Information On Turnover And Allocation Of Sales And Expense's.
Mr.Tushar D Morankar
35. 35
THIRD SCHEDULE
Include,
CATEGORY A :- LARGE UNIT WITH TURNOVER EXCEEDING
Rs. 6 crores per annum.
CATEGORY B :- MEDIUM SIZED UNIT TURNOVER BETWEEN
Rs. 1 crore to 6 crore per annum.
CATEGORY C :- OTHER UNITS WITH TURNOVER OF LESS THAN
Rs. 1 crore per annum.
Mr.Tushar D Morankar
36. 36
New Drug / New Formulation
A) NLEM (National List of Essential Medicines)
Formulations with same specified dosage and strength as combined with
another NLEM Formulations with same specified dosage and strength.
Example I:
• Paracetamol 500mg Tablet is Scheduled Formulation
• Diclofenac 50mg Tablet is Scheduled Formulation
• New Drug = Paracetamol 500mg + Diclofenac 50mg Tablet is New
Drug/Formulation.
Mr.Tushar D Morankar
37. 37
B) NLEM Formulations with same specified dosage and strength as combined with
another Non - NLEM Formulations
Example II:
• Paracetamol 500mg Tablet is Scheduled Formulation
• Aceclofenac 100mg Tablet is Non - Scheduled Formulation
• Paracetamol 500mg + Aceclofenac 100mg Tablet is New Drug
Mr.Tushar D Morankar
38. 38
C) NLEM Formulations by changing its strength
Example I:
• Paracetamol 500mg Tablet is a Scheduled Drug
• Paracetamol 325mg Tablet is a New Drug
D) NLEM Formulations by changing its dosage
Example I:
• Diclofenac 50mg Tablet is a Scheduled Drug.
• Diclofenac 50mg Ointment is a New Drug.
Mr.Tushar D Morankar
39. 39
OFFENCES AND PENALTIES
PENALTIES—
He shall be punishable with imprisonment for one year and also liable to fine.
In the case of any other order, with imprisonment for not less than three
months but which may extend to seven years and also be liable to fine.
Mr.Tushar D Morankar
40. 40
REFERENCES
Dr. Kuchekar B.S., Khadatare A.M., Itkar S.C., “Forensic Pharmacy”, Ed. 7th,
2008, NIRALI PRAKASHAN, P. 3.1-3.29.
Sampath K. “ Pharmaceutical Jurisprudence”, Ed. 3rd, BIRLA PUBLICATION, P.
170-177.
Gandhi Neerja, Popli Harvinder, “Pharmaceutical Jurisprudence”, Ed.1st, 2010,
CBS PUBLICATION, P. 136-154.
Mr.Tushar D Morankar