THE DRUGS (PRICES CONTROL)

46dbb08eda8223c46f69c1daae838ae226ad448f · 1955 · State unknown

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Parent: THE ESSENTIAL COMMODITIES ACT, 1955 (bac39fb263d3559d1cf00bdfe63ea462c35514fd)

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THE DRUGS (PRICES CONTROL) THE DRUGS (PRICES CONTROL) ORDER, 2013 ORDER, 2013 THE DRUGS (PRICES CONTROL) THE DRUGS (PRICES CONTROL) ORDER, 2013 ORDER, 2013 (Notified by SO 1221 (E) dated 15.05.2013 and as amended (Notified by SO 1221 (E) dated 15.05.2013 and as amended up to vide SO 1192(E) dated 22-03-2016) up to vide SO 1192(E) dated 22-03-2016) (Notified by SO 1221 (E) dated 15.05.2013 and as amended (Notified by SO 1221 (E) dated 15.05.2013 and as amended up to vide SO 1192(E) dated 22-03-2016) up to vide SO 1192(E) dated 22-03-2016) In exercise of the powers conferred by section 3 of the Essential In exercise of the powers conferred by section 3 of the Essential Commodities Act, 1955, (10 of 1955), and supersession of the Drug Commodities Act, 1955, (10 of 1955), and supersession of the Drug (Prices Control) Order, 1995, except as respect to things done or (Prices Control) Order, 1995, except as respect to things done or omitted to be done before such supersession, the Central omitted to be done before such supersession, the Central Government hereby makes the following Order, namely:- Government hereby makes the following Order, namely:In exercise of the powers conferred by section 3 of the Essential In exercise of the powers conferred by section 3 of the Essential Commodities Act, 1955, (10 of 1955), and supersession of the Drug Commodities Act, 1955, (10 of 1955), and supersession of the Drug (Prices Control) Order, 1995, except as respect to things done or (Prices Control) Order, 1995, except as respect to things done or omitted omitted to to be be done done before before such such supersession, supersession, the the Central Central Government hereby makes the following Order, namely:- Government hereby makes the following Order, namely:- 1. Short title and com

Rule TOC

1 · Short title and commencement.– (1) This Order may be called

1 · Short title and commencement.-— (1) This Order may be called the Drugs (Prices Control) Order, 2013.

2 · Definitions.–

2 · Definitions.— (1) In this Order, unless the context otherwise

2 · Definitions.— (1) In this Order, unless the context otherwise requires,–

1 · ]2 2 (w) "pharmacoeconomics" means a scientific discipline that

25 · and includes a supplementary price list; (y) "price to retailer" means the price of a drug at which it is sold

3 · Directions to manufacturers of active pharmaceutical

3 · Directions to manufacturers of active pharmaceutical ingredients or bulk drugs or formulations.–

3 · Directions

4 · Calculation of ceiling price of a scheduled formulation.-— (1)

5 · Calculation of retail price of a new drug for existing manufacturers of scheduled formulations.–

6 · Ceiling price of a scheduled formulation in case of no reduction in price due to absence of competition.–

4 · Calculation of ceiling price of a scheduled formulation.-— (1) The ceiling price of a scheduled formulation of specified strengths

5 · Calculation of retail price of a new drug for existing manufacturers of scheduled formulations.– (1) The retail price

6 · Ceiling price of a scheduled formulation in case of no reduction in price due to absence of competition.– (1) where

7 · Margin to retailer.–

7 · Margin to retailer.— While fixing a ceiling price of scheduled

7 · Margin to retailer.— While fixing a ceiling price of scheduled formulations and retail prices of new drugs, sixteen percent of price

8 · Maximum retail price.–

8 · Maximum retail price.— (1) The maximum retail price of

8 · Maximum

9 · Reference data and source of market based data.–

9 · Reference data and source of market based data.(1)

9 · Reference data and source of market based data.- (1) Initially, the source of market based data shall be the data available

10 · Pricing of the formulations covered under Drugs (Prices

10 · Pricing of the formulations covered under Drugs (Prices Control) Order, 1995.–

10 · Pricing of the formulations covered under Drugs (Prices Control) Order, 1995.– (1) The prices of scheduled formulations,

11 · Ceiling price or retail price of a pack.– (1) The average price

11 · Ceiling price or retail price of a pack.— (1) The average price to retailer calculated as per the provisions in paragraphs 4, 5 and 6

12 · Price of formulations (branded or generic version) listed in the National List of Essential Medicines, launched by a

11 · Ceiling price or retail price of a pack.— (1) The average price to retailer calculated as per the provisions in paragraphs 4, 5 and 6

12 · Price of formulations (branded or generic version) listed in the National List of Essential Medicines, launched by a

3 · inserted vide S.O.1192(E), dated 22.03.2016

3 · inserted vide S.0.1192(E), dated 22.03.2016

13 · Price of scheduled formulations for the existing

13 · Price of scheduled formulations for the _ existing manufacturers.–

13 · Price

16 · (3) Annual increase in maximum retail price may be carried out as

16 ·

14 · Fixation of ceiling price of scheduled formulations.– (1)

14 · Fixation of ceiling price of scheduled formulations.— (1)

14 · Fixation of ceiling price of scheduled formulations.–

14 · Fixation of ceiling price of scheduled formulations.— (1)

15 · Fixation of retail price of a new drug for existing

15 · Fixation of retail price of a new drug for existing manufacturers of scheduled formulations.– (1) The Government

15 · Fixation

16 · Revision of ceiling price of scheduled formulations.— (1)

17 · Amendment of the list of scheduled formulation.— (1) A

17 · Amendment of the list of scheduled formulation.— (1) A decision to amend the first schedule, clearly stating the reasons

18 · Revision of ceiling price on the basis of moving annual

18 · Revision of ceiling price on the basis of moving annual turnover (MAT).–

18 · Revision of ceiling price on the basis of moving annual turnover (MAT).– The revision of ceiling prices on the basis of

19 · Fixation of ceiling price of a drug under certain

19 · Fixation of ceiling price of a drug under certain circumstances.- Notwithstanding anything contained in this order,

19 · Fixation

20 · Monitoring the prices of non-scheduled formulations.–

20 · Monitoring the prices of non-scheduled formulations.-— (1)

20 · Monitoring the prices of non-scheduled formulations.-— (1) The Government shall monitor the maximum retail prices (MRP) of

21 · Monitoring the availability of scheduled formulations.– (1)

21 · Monitoring the availability of scheduled formulations.-— (1) The Government shall monitor the production and availability of

22 · Recovery of dues accrued under the Drugs (Prices

22 · Recovery of dues accrued under the Drugs (Prices Control) Order, 1979 and to deposit the same into the Drugs

22 · Recovery

23 · Recovery of overcharged amount under Drugs Prices

23 · Recovery of overcharged amount under Drugs Prices Control Orders 1987 and 1995.–

23 · Recovery of overcharged amount under Drugs Prices

1987 · and

1995 · Notwithstanding

1995 · under the provisions of this Order. 24. Carrying into effect the price fixed or revised by the

24 · Carrying into effect the price fixed or revised by the Government, its display and proof thereof.–

25 · Display of prices of non-scheduled formulations and price list thereof.–

1995 · under the provisions of this Order. 24. Carrying into effect the price fixed or revised by the

24 · Carrying into effect the price fixed or revised by the Government, its display and proof thereof.– (1) For all the

25 · Display of prices of non-scheduled formulations and price list

26 · Control of sale prices of formulations.–

26 · Control of sale prices of formulations.— No person shall sell

26 · Control of sale prices of formulations.— No person shall sell any formulation to any consumer at a price exceeding the price

27 · Sale of split quantities of formulations.–

27 · Sale of split quantities of formulations.— No dealer shall sell

27 · Sale of split quantities of formulations.— No dealer shall sell loose quantity of any formulation at a price which exceeds the pro

28 · Manufacturer, distributor or dealer not to refuse sale of

28 · Manufacturer, distributor or dealer not to refuse sale of drug.–

1940 · (23 of 1940) and the rules made thereunder, (a) no manufacturer or distributor shall withhold from sale or refuse

28 · Manufacturer, distributor or dealer not to refuse sale of drug.– Subject to the provisions of the Drug and Cosmetics Act,

1940 · (23 of 1940) and the rules made thereunder, (a) no manufacturer or distributor shall withhold from sale or refuse

29 · Maintenance of records and production thereof for

29 · Maintenance of records and production thereof for inspection.–

29 · Maintenance

30 · Power of entry, search and seizure.–

30 · Power of entry, search and seizure.— (1) Any Gazetted

30 · Power of entry, search and seizure.— (1) Any Gazetted Officer of the Central Government or of a State Government, as the

31 · Power to review.–

31 · Power to review.-— Any person aggrieved by any notification

31 · Power to review.-— Any person aggrieved by any notification issued or order made under paragraphs 4, 5 and 6 of this Order,

32 · Non–application of the provisions of this order in certain

32 · Non-application of the provisions of this order in certain cases.- The provisions of this order shall not apply to, -

6 · 4.3.3-Integrase inhibitors

11 · 1-Blood and Blood components

11 · 1-Blood and Blood components 11.1-Blood and Blood components

11 · 1-Blood and Blood components

11 · 2-Plasma substitutes

11 · 2-Plasma substitutes 11.2-Plasma substitutes

11 · 2-Plasma substitutes

11 · 3-Plasma fractions for specific use

11 · 3-Plasma fractions for specific use 11.3-Plasma fractions for specific use

11 · 3-Plasma fractions for specific use

22 · 1-Diagnostic agents

22 · 1-Diagnostic agents 22.1-Diagnostic agents

22 · 1-Diagnostic agents

22 · 3- Vaccines

22 · 3- Vaccines 22.3- Vaccines

22 · 3- Vaccines

22 · 3.1-For universal immunisation

22 · 3.1-For universal immunisation 22.3.1-For universal immunisation

22 · 3.1-For universal immunisation

23 · 2

23 · 3

23 · 4

23 · 5

24 · 1

24 · 2

24 · 3

25 · 1- Anti-infective medicine

25 · 1- Anti-infective medicine 25.1- Anti-infective medicine

25 · 1- Anti-infective medicine

4 · Substituted vide SO 701(E) dated 10-03-2016 vide Drugs (Price Control) Amendment Order, 2016

12 · . Any other information relevant to product and its process of

12 · Any other information relevant to product and its process of

15 · Any other information relevant to discontinuation of

15 · Any other information relevant to discontinuation of scheduled formulation: