Diese Präsentation wurde erfolgreich gemeldet.
Wir verwenden Ihre LinkedIn Profilangaben und Informationen zu Ihren Aktivitäten, um Anzeigen zu personalisieren und Ihnen relevantere Inhalte anzuzeigen. Sie können Ihre Anzeigeneinstellungen jederzeit ändern.
1
Seminar on
DRUG (PRICE CONTROL) ORDER ACT, 1995
PRESENTED BY-
Tushar D. Morankar.
(T.Y.B.Pharm)
Guided By-
K.D.Mali Sir
...
2
CONTENT
▪ Introduction
▪ History
▪ Amendments
▪ Objectives
▪ Definitions
▪ Prices of bulk drugs
▪ Information required f...
3
Cont.…….
▪ Fixation of price under certain circumstances
▪ Power to recover overcharged amount
▪ Control of sale prices ...
4
DRUG -
A substance intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease.
PRICE-
The ...
5
❖ The drug price control order (DPCO) is an order issued by the
government under the Essential Commodities Act which
ena...
6
DPCO ACT, 2013
DPCO ACT, 1995
Confirmed by Section 3 of
Essential Commodities Act, 1955.
Mr.Tushar D Morankar
7
HISTORY
In 1966, parliament members felt that
manufacturers charging high rate on drugs.
To control on high drug rates,
...
8
DPCO Act, 1966 replaced by DPCO Act, 1970.
In 1974, Hathi Committee was formed and submitted it’s reports in 1975.
DPCO ...
9
AMMENDMENTS
▪ Drug Price Control Order, 1970
▪ Drug Price Control Order, 1979
▪ Drug Price Control Order, 1987
▪ Drug Pr...
10Mr.Tushar D Morankar
https://youtu.be/TGT2ZU3b9I4
11
OBJECTIVES
✓ To Achieve Adequate Production
✓ To regulate Equal Distribution
✓ To Maintain and Increase Supply Of Bulk ...
12
DPCO 2013
The government has notified the DPCO 2013 under the Essential Commodities
Act, 1955, which will give power to...
13
• Margins of wholesalers & retailers have been cut down to
8% & 16% respectively.
• Monitoring the M.R.P of Non-Schedul...
14
 To implement and enforce the provisions of the Drugs (Prices Control) Order
in accordance with the powers delegated t...
Mr.Tushar D Morankar 15
DPCO 1995 DPCO 2013
It is governed by Essential commodities act
1955
It is governed by national ph...
16
DEFINITIONS
BULK DRUGS :-
It means any pharmaceutical, chemical and biological or plant product
conform to pharmacopoei...
17
DRUG :-
Substance intended to be used for or in the diagnosis, treatment, or
prevention of any disease or disorder in h...
18
PRICES OF BULK DRUGS
Government has power to fix the maximum sale price.
A) While fixing the sale price government shal...
19
PRICES OF BULK DRUGS
B) At the time of production of drug, manufacturer fill detail in FORM-I and give
necessary inform...
20
Information Required From Manufacturer to The Government
➢ For the both Scheduled and Non-scheduled bulk drugs
➢ List o...
21
RETAIL PRICE OF FORMULATION
CALCULATION :-
FORMULA :
Where, R.P. = Retail Price
M.C.= Material Cost
C.C.= Conversion Co...
22
POWER TO FIX RETAIL PRICE OF SCHEDULED FORMULATION
➢ Government fix the Retail Price Of Bulk Drug.
➢ And manufacturer u...
23
No Person Shall Sell Imported Scheduled Formulation.
Manufacturer Should Not Marketed New Formulation.
Manufacturer Sho...
24
POWER TO FIX CEILING PRICE OF SCHEDULED FORMULATION
➢ Government fix the Ceiling Price of Scheduled Formulation with fo...
25
PRICING OF SCHEDULED FORMULATION
The ceiling price of a scheduled formulation of specified strengths and dosages as
spe...
26
• Step II. Thereafter, the ceiling price of the scheduled formulation i.e. P(c) shall be
calculated as below:
P(c) = P(...
27
Maximum retail price:
(1)The maximum retail price of scheduled formulations shall be fixed by the
manufacturers on the ...
28
POWER TO REVISE PRICE OF BULK DRUG AND FORMULATION
➢ Government Fix or Revise Retail Price of One or more Formulation.
...
29
FIXATION OF PRICE UNDER CERTAIN CIRCUMSTANCES
➢ If any Manufacturer of Bulk Drug Fails to Submit the Application For Fi...
30
POWER TO RECOVER OVERCHARGED AMOUNT
➢If any manufacturer or importer charging higher price than
the price fixed by gove...
31
CONTROL OF SALE PRICES OF BULK DRUG AND FORMULATION
➢ No person or retailer shall sale the drug/ formulation
➢ To any c...
32
SALE OF SPLIT QUANTITY OF FORMULATION
➢ No dealer shall sell the loose quantity of formulation
➢ At price exceeding pro...
33
SCHEDULES RELATED WITH DPCO ACT, 1995
FIRST SCHEDULE
▪ First Schedule Includes 76 Bulk Drugs.
▪ E.g. Penicillin, Raniti...
34
SECOND SCHEDULE
❖ Different Forms Included :-
▪ FORM- I :- Application For Fixation/ Revision Of Price.
▪ FORM- II :- I...
35
THIRD SCHEDULE
Include,
CATEGORY A :- LARGE UNIT WITH TURNOVER EXCEEDING
Rs. 6 crores per annum.
CATEGORY B :- MEDIUM S...
36
New Drug / New Formulation
A) NLEM (National List of Essential Medicines)
Formulations with same specified dosage and s...
37
B) NLEM Formulations with same specified dosage and strength as combined with
another Non - NLEM Formulations
Example I...
38
C) NLEM Formulations by changing its strength
Example I:
• Paracetamol 500mg Tablet is a Scheduled Drug
• Paracetamol 3...
39
OFFENCES AND PENALTIES
PENALTIES—
❑ He shall be punishable with imprisonment for one year and also liable to fine.
❑ In...
40
REFERENCES
❖ Dr. Kuchekar B.S., Khadatare A.M., Itkar S.C., “Forensic Pharmacy”, Ed. 7th,
2008, NIRALI PRAKASHAN, P. 3....
41Mr.Tushar D Morankar
Nächste SlideShare
Wird geladen in …5
×
Nächste SlideShare
What to Upload to SlideShare
Weiter
Herunterladen, um offline zu lesen und im Vollbildmodus anzuzeigen.

47

Teilen

Herunterladen, um offline zu lesen

Drug price control order 2013

Herunterladen, um offline zu lesen

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.

Ähnliche Bücher

Kostenlos mit einer 30-tägigen Testversion von Scribd

Alle anzeigen

Ähnliche Hörbücher

Kostenlos mit einer 30-tägigen Testversion von Scribd

Alle anzeigen

Drug price control order 2013

  1. 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. 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. 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. 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. 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. 6 DPCO ACT, 2013 DPCO ACT, 1995 Confirmed by Section 3 of Essential Commodities Act, 1955. Mr.Tushar D Morankar
  7. 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. 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. 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
  10. 10. 10Mr.Tushar D Morankar https://youtu.be/TGT2ZU3b9I4
  11. 11. 11 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
  12. 12. 12 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 https://youtu.be/LPVbeP5YLiI
  13. 13. 13 • 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
  14. 14. 14  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
  15. 15. Mr.Tushar D Morankar 15 DPCO 1995 DPCO 2013 It is governed by Essential commodities act 1955 It is governed by national pharmaceutical pricing authority, based on national list of essential medicines Prices of only 74 drugs were regulated by this act Prices of 652 drugs are regulated by this act If once the prices are fixed,they can’t be changed as per the act Based on simple average price (SAP) the highest prices can be lowered depending on the margins Ceiling and non-ceiling prices of drugs are not Specified Ceiling and non-ceiling prices of drugs are specified This act facilitates Win –Win situation for the government, but not for the Industries The prices of the drugs are fixed by the mutual agreement of government and industries for the welfare of the public
  16. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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
  41. 41. 41Mr.Tushar D Morankar
  • makkenavenkatesh

    Sep. 23, 2021
  • bhagyasri

    Jul. 30, 2021
  • BhagyalaxmiReapakula

    Jul. 9, 2021
  • 8888162681

    Jul. 2, 2021
  • SBani1

    Jul. 1, 2021
  • VarshaSingh229

    Apr. 3, 2021
  • PRACHIKULKARNI56

    Mar. 26, 2021
  • CHANDANAMATSA

    Mar. 18, 2021
  • SumedhaSavane

    Mar. 5, 2021
  • SudhanDuraisamy

    Mar. 4, 2021
  • PRATISHTTHABHARADWAJ2

    Feb. 27, 2021
  • GoodishGoodish

    Feb. 26, 2021
  • NkhlChudhr

    Feb. 24, 2021
  • 1Ishasahu1

    Feb. 12, 2021
  • SrivalliMalavikaVyak

    Jan. 29, 2021
  • NiketaKulshrestha

    Jan. 22, 2021
  • Shivani_sardhara

    Dec. 29, 2020
  • RajuGupta101

    Dec. 23, 2020
  • SanjanaSubudhi

    Dec. 19, 2020
  • chougulepranita

    Nov. 24, 2020

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.

Aufrufe

Aufrufe insgesamt

14.662

Auf Slideshare

0

Aus Einbettungen

0

Anzahl der Einbettungen

1

Befehle

Downloads

424

Geteilt

0

Kommentare

0

Likes

47

×