Download - National Pharmaceutical Pricing Authority (NPPA)

The National Pharmaceutical Pricing Authority (NPPA) was constituted by Government of India Resolution dated August 29, 1997 as an attached office of the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, as an independent regulator for the pricing of drugs and to ensure the availability and accessibility of medicines at affordable prices.

It has been entrusted inter-alia, with the following functions:

- To implement and enforce the provisions of the Drugs Price Control Order (DPCO), 1995/2013  in accordance with the powers delegated to it.

- To undertake and/or sponsor relevant studies in respect of pricing of drugs/formulations.

- 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 deal with all legal matters arising out of the decisions of the Authority.

- 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.

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Drugs Prices Control Order, 2013 (DPCO 2013)

The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, notified the Drug (Prices Control) Order 2013 (DPCO 2013) in May 2013, which may fluctuate the pricing of 348 essential drugs. Prior to the 2013 regime, the DPCO 1995 included 74 bulk drugs within its ambit and the pricing of the drugs were fixed on the basis of manufacturing costs declared by the drug manufacturers.

The DPCO 2013 empowers the National Pharmaceutical Pricing Authority (NPPA) to regulate the prices of 348 essential drugs. As per the DPCO 2013, all strengths and dosages specified in the National List of Essential Medicines (NLEM) will be under price control.

Para 2(i) of the DPCO 2013 defines the term "Formulation" as a medicine processed out of or containing one or more drugs with or without the use of any pharmaceutical aids, for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease and, but shall not include –

- i. any medicine included in any bonafide Ayurvedic (including Sidha) or Unani (Tibb) systems of medicines;

- ii. any medicine included in the Homeopathic system of medicine; and

- iii. any substance to which the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) do not apply;

As per the DPCO 2013, "Scheduled formulation" means any formulation, included in the First Schedule whether referred to by generic versions or brand names. "Non-scheduled formulation" has been defined as a formulation, the dosage, and strengths of which are not specified in the First Schedule.

"Schedule" is the Schedule appended to the DPCO 2013.

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Pricing of Scheduled Formulations:

Para 4 of the DPCO 2013 provides a formula for the calculation of the ceiling price of a scheduled formulation as follows –

Step1. First, the Average Price to the Retailer of the scheduled formulation i.e. P(s) shall be calculated as below:

The average price to retailer P(S) = (Sum of prices to the 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 on the basis of moving annual turnover of that medicine) / (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.)

Step2. 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 step 1 above. M = % Margin to retailer and its value =16

Calculation of Ceiling Prices of the following has also been provided in the DPCO 2013.

- a. Ceiling price of a scheduled formulation in case of no reduction in price due to the absence of competition

- b. Calculation of Retail price of a new drug for existing manufacturers of scheduled formulations.

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Pricing of Non-Scheduled Formulations:

Apart from the price fixation of the scheduled formulations, the NPPA is also empowered to monitor the maximum retail prices (MRP) of all the drugs, including the non-scheduled formulations, and ensure that no manufacturer increases the maximum retail price of a drug more than ten percent of the maximum retail price during the preceding twelve months, and where the increase is beyond ten percent of the maximum retail price, it is empowered to reduce the same to the level of ten percent of the maximum retail price for the next 12 months.

The manufacturer shall be liable to deposit the overcharged amount along with interest thereon from the date of the increase in price in addition to the penalty.

Display of prices of Scheduled & Non-Scheduled formulations and price list:

Paragraphs 24 and 25 of the DPCO 2013 mandate that every manufacturer of a scheduled or non-scheduled formulation intended for sale shall display, in indelible print, on the label of the container of the formulation and the minimum pack thereof offered for retail sale, the maximum retail price of that formulation, with the words "Maximum Retail Price" preceding it and the words 'inclusive of all taxes' succeeding it.

Para 26 lays down that no person shall sell any formulation to any consumer at a price exceeding the price specified in the current price list or price indicated on the label of the container or pack thereof, whichever is less.

Recovery of overcharged amount under DPCO 1987 & 1995:

Under the provisions of this Order, the government shall, by notice, require the manufacturers, importers, distributors, or as the case may be, to deposit the amount accrued due to the charging of prices higher than those fixed or notified by the government under the provisions of the Drugs (Prices Control) Order, 1987, and the Drug (Prices Control) Order, 1995.

The margin of retailer & maximum retail price:

Paragraph 7 lays down that while fixing a ceiling price for scheduled formulations and retail prices of new drugs, sixteen percent of the price to the retailer as a margin to the retailer shall be allowed.

Para 8 specifies that the maximum retail price of scheduled formulations shall be fixed by the manufacturers on the basis of the ceiling price notified by the Government plus local taxes wherever applicable.

Even the loose quantities of any formulation shall not be sold at a price that is in excess of the pro-rata price of the formulation.

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DPCO order

Drugs (Price Control) Amendment Order 2019

Drugs-Price-Control-Amendment-Order-2019

Drugs (Prices Control) Order, 2013 (DPCO)

Drugs-Price-Control-Order-2013

Drugs (Prices Control) Order, 1995 (DPCO)

Drugs-Price-Control-Order-1995

Drugs (Price Control) Order 1979 (DPCO)

Drugs-Price-Control-Order-1979

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DPCO – Schedule-I

Click below link

Schedule-1 amendment S.O.-508E-dt-01-02-2021-Amendment-in-Schedule-I-of-the-DPCO-2013

Schedule-I – S.O.-701E-dt-10-03-2016-Drugs-Price-Control-Amendment-Order-2016-Regarding-Schedule-I-Drugs-and-doage-form

Price List

2022

S.O. 5939(E) dt 19-12-2022 NPPA has fixed the Ceiling price of 12 scheduled formulations under Drugs (Prices Control) Order, 2013 (NLEM 2022) based on the decision of 105th Authority meeting dated 15.12.2022

S.O.-5939E-dt-19-12-2022-NPPA-has-fixed-Ceiling-price-of-12-scheduled-formulations-under-Drugs-Prices-Control-Order-2013-NLEM-2022-based-on-the-decision-of-105th-Authority-meeting-dated-15.12.2022

S.O. 5938(E) dt 19-12-2022 NPPA has revised the Ceiling price of 107 scheduled formulations under Drugs (Prices Control) Order, 2013 (NLEM 2022) based on the decision of 105th Authority meeting dated 15.12.2022

S.O.-5938E-dt-19-12-2022-NPPA-has-revised-Ceiling-price-of-107-scheduled-formulations-under-Drugs-Prices-Control-Order-2013-NLEM-2022-based-on-the-decision-of-105th-Authority-meeting-dated-15.12.2022

S.O. 5937(E) dt 19-12-2022 NPPA has fixed retail prices of 10 formulations under Drugs (Prices Control) Order, 2013 based on the decision of the 105th Authority meeting dated 15.12.2022

S.O.-5937E-dt-19-12-2022-NPPA-has-fixed-retail-prices-of-10-formulations-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-105th-Authority-meeting-dated-15.12.2022

S.O. 5511 (E) dt 28-11-2022 NPPA has fixed retail prices of 01 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 104th Authority meeting dated 23.11.2022

S.O.-5511-E-dt-28-11-2022-NPPA-has-fixed-retail-prices-of-01-formulations-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-104th-Authority-meeting-dated-23.11.2022

S.O. 5388(E) dt 18-11-2022 NPPA has fixed retail prices of 40 formulations under DPCO 2013 based on the decision of the 103rd Authority meeting dated 10.11.2022.

S.O.-5388E-dt-18-11-2022-NPPA-has-fixed-retail-prices-of-40-formulations-under-DPCO-2013-based-on-the-decision-of-103rd-Authority-meeting-dated-10.11.2022.

S.O. 4595(E) dt 29-09-2022 Extension Revised ceiling price of Dextrose Injection in 100ml pack having special features under Drugs (Prices Control) Order, 2013 based on the decision of 102nd Authority meeting dated 27.09.2022.

S.O.-4595E-dt-29-09-2022-Extension-Revised-ceiling-price-of-Dextrose-Injection-in-100ml-pack-having-special-features-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-102nd-Authority-meeting-dated-27.09.2022.

S.O. 4594(E) dt 29-09-2022 Extension Revised ceiling price of Mannitol Injection 20% in 100ml pack having special features under Drugs (Prices Control) Order, 2013 based on the decision of 102nd Authority meeting dated 27.09.2022.

S.O.-4594E-dt-29-09-2022-Extension-Revised-ceiling-price-of-Mannitol-Injection-20-in-100ml-pack-having-special-features-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-102nd-Authority-meeting-dated-27.09.2022.

S.O. 4593(E) dt 29-09-2022 Extension Revised ceiling price of Metronidazole Injection IP in 100ml pack having special features under Drugs (Prices Control) Order, 2013 based on the decision of 102nd Authority meeting dated 27.09.2022.

S.O.-4593E-dt-29-09-2022-Extension-Revised-ceiling-price-of-Metronidazole-Injection-IP-in-100ml-pack-having-special-features-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-102nd-Authority-meeting-dated-27.09.2022.

S.O. 4592(E) dt 29-09-2022 Extension of revised ceiling price of Ringer Lactate Injection having special features under Drugs (Prices Control) Order, 2013 based on the decision of 102nd Authority meeting dated 27.09.2022.

S.O.-4592E-dt-29-09-2022-Extension-of-revised-ceiling-price-of-Ringer-Lactate-Injection-having-special-features-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-102nd-Authority-meeting-dated-27.09.2022.

S.O. 4591(E) dt 29-09-2022 Extension of revised ceiling price of IV Fluid Injection having special features under Drugs (Prices Control) Order, 2013 based on the decision of 102nd Authority meeting dated 27.09.2022.

S.O.-4591E-dt-29-09-2022-Extension-of-revised-ceiling-price-of-IV-Fluid-Injection-having-special-features-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-102nd-Authority-meeting-dated-27.09.2022.

S.O. 4590(E) dt 29-09-2022 Extension of revised price of Liquid Medical Oxygen (LMO) and Oxygen Inhalation (Medicinal Gas) in cylinder under Drugs (Prices Control) Order, 2013 based on the decision of Authority meeting dated 27

S.O.-4590E-dt-29-09-2022-Extension-of-revised-price-of-Liquid-Medical-Oxygen-LMO-and-Oxygen-Inhalation-Medicinal-Gas-in-cylinder-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-Authority-meeting-dated-27

S.O. 4589(E) dt 29-09-2022 Extension of revised ceiling price of Heparin Injection under Drugs (Prices Control) Order, 2013 based on the decision of 102nd Authority meeting dated 27.09.2022.

S.O.-4589E-dt-29-09-2022-Extension-of-revised-ceiling-price-of-Heparin-Injection-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-102nd-Authority-meeting-dated-27.09.2022.

S.O. 4588(E) dt 29-09-2022 NPPA has fixed retail prices of 40 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 102nd Authority meeting dated 27.09.2022

S.O.-4588E-dt-29-09-2022-NPPA-has-fixed-retail-prices-of-40-formulations-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-102nd-Authority-meeting-dated-27.09.2022.

S.O. 4343(E) dt 15-09-2022 Notification regarding extension of Knee implants under Drugs (Prices Control) Order, 2013.

S.O.-4343E-dt-15-09-2022-Notification-regarding-extension-of-Knee-implants-under-Drugs-Prices-Control-Order-2013.

S.O. 4342(E) dt 15-09-2022 NPPA has fixed retail prices of 1 formulation under Drugs (Prices Control) Order, 2013 (WPA) based on the decision of 101st Authority meeting dated 07.09.2022.

S.O.-4342E-dt-15-09-2022-NPPA-has-fixed-retail-prices-of-1-formulation-under-Drugs-Prices-Control-Order-2013-WPA-based-on-the-decision-of-101st-Authority-meeting-dated-07.09.2022.

S.O. 4341(E) dt 15-09-2022 NPPA has fixed retail prices of 36 formulations under the Drugs (Prices Control) Order, 2013 based on the decision of the 101st Authority meeting dated 07.09.2022.

S.O.-4341E-dt-15-09-2022-NPPA-has-fixed-retail-prices-of-36-formulations-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-101st-Authority-meeting-dated-07.09.2022.

OM dated 25.08.2022 relating to fixation of Ceiling Price of Sodium Chloride 0.45% Injection.

OM-dated-25.08.2022-relating-to-fixation-of-Ceiling-Price-of-Sodium-Chloride-0.45-Injection.

S.O. 4002(E) dt 24-08-2022 NPPA has fixed retail prices of 45 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 100th Authority meeting dated 05.08.2022.

S.O.-4002E-dt-24-08-2022-NPPA-has-fixed-retail-prices-of-45-formulations-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-100th-Authority-meeting-dated-05.08.2022.

S.O. dt 29-07-2022 Notification regarding extension of capping of trade margin of 5 Medical Devices

S.O.-dt-29-07-2022-Notification-regarding-extension-of-capping-of-trade-margin-of-5-Medical-Devices

S.O. 2983(E) dt 30-06-2022 Notification regarding extension of price regulation on Oxygen Concentrator

S.O.-2983E-dt-30-06-2022-Notification-regarding-extension-of-price-regulation-on-Oxygen-Concentrator

S.O. 2982(E) dt 30-06-2022 Notification regarding extension of price regulation on LMO and Oxygen Inhalation

S.O.-2982E-dt-30-06-2022-Notification-regarding-extension-of-price-regulation-on-LMO-and-Oxygen-Inhalation

S.O. 2981(E) dt 30-06-2022 NPPA has fixed the retail prices of 84 new drugs based on the decision taken in 99th Authority meeting dated 28.06.2022

S.O.-2981E-dt-30-06-2022-NPPA-has-fixed-the-retail-prices-of-84-new-drugs-based-on-the-decision-taken-in-99th-Authority-meeting-dated-28.06.2022

S.O. 2465(E) dt 30-05-2022 Notification regarding extension of TMR notification on Oxygen Concentrators

S.O.-2465E-dt-30-05-2022-Notification-regarding-extension-of-TMR-notification-on-Oxygen-Concentrators

S.O. 2166 (E) DT 09-05-2022 NPPA has revised retail price of 1 formulation under Drugs (Prices Control) Order, 2013 based on review order.

S.O.-2166-E-DT-09-05-2022-NPPA-has-revised-retail-price-of-1-formulation-under-Drugs-Prices-Control-Order-2013-based-on-review-order.

S.O. 2165(E) Dt 09-05-2022 NPPA has fixed retail prices of 18 formulations under Drugs (Prices Control) Order, 2013 the price of which were applied earlier in the 96th Authority meeting dated 24.03.2022.

S.O.-2165E-Dt-09-05-2022-NPPA-has-fixed-retail-prices-of-18-formulations-under-Drugs-Prices-Control-Order-2013-the-price-of-which-were-applied-earlier-in-the-96th-Authority-meeting-dated-24.03.2022.

S.O. 2164(E) Dt 09-04-2022 NPPA has fixed retail prices of 66 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 97th Authority meeting dated 06.05.2022.

S.O.-2164E-Dt-09-04-2022-NPPA-has-fixed-retail-prices-of-66-formulations-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-97th-Authority-meeting-dated-06.05.2022.

S.O. 1833(E) dt 18-04-2022 NPPA has fixed retail prices of 15 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 96th Authority meeting dated 24.03.2022

S.O.-1833E-dt-18-04-2022-NPPA-has-fixed-retail-prices-of-15-formulations-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-96th-Authority-meeting-dated-24.03.2022

S.O. 1782(E) dt 12-04-2022 NPPA has fixed retail prices of 23 formulations under Drugs (Prices Control) Order, 2013 based on the decision of 96th Authority meeting dated 24.03.2022

S.O.-1782E-dt-12-04-2022-NPPA-has-fixed-retail-prices-of-23-formulations-under-Drugs-Prices-Control-Order-2013-based-on-the-decision-of-96th-Authority-meeting-dated-24.03.2022

S.O. 1508(E) dt 30-03-2022 NPPA has fixed ceiling prices of Liquid Medical Oxygen, Medical Inhalation under Drugs (Prices Control) Order, 2013

S.O.-1508E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-Liquid-Medical-Oxygen-Medical-Inhalation-under-Drugs-Prices-Control-Order-2013

S.O. 1507(E) dt 30-03-2022 NPPA has fixed ceiling prices of Heparin Injection under Drugs (Prices Control) Order, 2013

S.O.-1507E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-Heparin-Injection-under-Drugs-Prices-Control-Order-2013

S.O. 1506(E) dt 30-03-2022 NPPA has fixed ceiling prices of Dextrose under Drugs (Prices Control) Order, 2013

S.O.-1506E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-Dextrose-under-Drugs-Prices-Control-Order-2013

S.O. 1505(E) dt 30-03-2022 NPPA has fixed ceiling prices of Mannitol under Drugs (Prices Control) Order, 2013

S.O.-1505E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-Mannitol-under-Drugs-Prices-Control-Order-2013

S.O. 1504(E) dt 30-03-2022 NPPA has fixed ceiling prices of Metronidazole under Drugs (Prices Control) Order, 2013

S.O.-1504E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-Metronidazole-under-Drugs-Prices-Control-Order-2013

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S.O. 1503(E) dt 30-03-2022 NPPA has fixed ceiling prices of 9 formulations under Drugs (Prices Control) Order, 2013

S.O.-1503E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-9-formulations-under-Drugs-Prices-Control-Order-2013

S.O. 1502(E) dt 30-03-2022 NPPA has fixed ceiling prices of 2 Coronary stents under Drugs (Prices Control) Order, 2013

S.O.-1502E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-2-Coronary-stents-under-Drugs-Prices-Control-Order-2013

S.O. 1501(E) dt 30-03-2022 NPPA has fixed ceiling prices of 4 formulations under Drugs (Prices Control) Order, 2013

S.O.-1501E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-4-formulations-under-Drugs-Prices-Control-Order-2013

S.O. 1500(E) dt 30-03-2022 NPPA has fixed ceiling prices of 8 formulations under Drugs (Prices Control) Order, 2013

S.O.-1500E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-8-formulations-under-Drugs-Prices-Control-Order-2013

S.O. 1499(E) dt 30-03-2022 NPPA has fixed ceiling prices of 872 formulations under Drugs (Prices Control) Order, 2013

S.O.-1499E-dt-30-03-2022-NPPA-has-fixed-ceiling-prices-of-872-formulations-under-Drugs-Prices-Control-Order-2013

OM. dt 25-03-2022 Movement in Wholesale Price Index (WPI) for the preceding calendar year 2021

OM.-dt-25-03-2022-Movement-in-Wholesale-Price-Index-WPI-for-the-preceding-calendar-year-2021

S.O. 796(E) dt 18-02-2022 NPPA has fixed ceiling prices of 19 formulations under Drugs (Prices Control) Order, 2013

S.O.
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