Food and Drugs Administration, (FDA) Haryana, India. |
Email ID: dahiya19@yahoo.com
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Last Updated on March 27, 2025 by The Health Master
Download Latest on National Pharmaceutical Pricing Authority (NPPA)
National Pharmaceutical Pricing Authority (NPPA) was constituted by a 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.
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 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 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 name. “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.
Pricing of Scheduled Formulations:
Para 4 of the DPCO 2013 provides formula for the calculation of ceiling price of a scheduled formulation as follows –
Step1. 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 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 step1 above. M = % Margin to retailer and its value =16
Calculation of Ceiling Prices of 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 absence of competition
- b. Calculation of Retail price of a new drug for existing manufacturers of scheduled formulations.
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 maximum retail price during preceding twelve months and where the increase is beyond ten percent of maximum retail price, it is empowered to reduce the same to the level of ten percent of maximum retail price for next 12 months. The manufacturer shall be liable to deposit the overcharged amount along with interest thereon from the date of increase in price in addition to the penalty.
Display of prices of Scheduled & Non-Scheduled formulations and price list:
Para 24 and 25 of the DPCO 2013 mandate that every manufacturer of a Scheduled & non-Scheduled formulation intended for sale shall display in indelible print mark, on the label of 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:
Para 23 states that notwithstanding anything contained in the order, the Government shall by notice, require the manufacturers, importer or distributor or as the case may be, to deposit the amount accrued due to charging of prices higher than those fixed or notified by the Government under the provisions of Drugs (Prices Control) Order, 1987 and Drugs (Prices Control) Order, 1995 under the provisions of this Order.
Margin of retailer & maximum retail price:
Para 7 lays down that 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. Para 8 specifies that 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. Even the loose quantities of any formulation shall not be sold at a price which is in excess of pro-rata price of the formulation.
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
DPCO – Schedule-I
Click below link
Schedule-1 amendment S.O.-508E-dt-01-02-2021-Amendment-in-Schedule-I-of-the-DPCO-2013
Price List
Updated price list
NPPA Updated Price List as on 14-10-2024
NPPA Updated Price List as on 14-10-2024
NPPA updated price list as on 28-06-2023
NPPA updated price list as on 28-06-2023
NPPA updated notified ceiling prices under DPCO, 2013 (updated as on 10.8.2022)
NPPA-updated-notified-ceiling-prices-under-DPCO-2013-updated-upto-10.8.2022
Office memorandum year wise
2025
NPPA OM 26-03-2025 regarding Movement in Wholesale Price Index (WPI) for the preceding calendar year 2024 over the year 2023
2023
NPPA OM 10-10-2023 Clarification regarding increase in the price of Orthopedic Knee Implants w.r.t Notification No. S.O.4078(E) dated 15th September 2023
NPPA OM dt 03-01-2023 Fixation of Ceiling Prices for Scheduled formulations under Revised Schedule I (NLEM 2022) of DPCO 2013 notified vide S.O. No. 5249 (E) dated 11.11.2022
2022
NPPA OM dt 30-12-2022 Extension of last date for filing statutory forms prescribed under DPCO, 2013
NPPA-OM-dt-30-12-2022-Extension-of-last-date-for-filing-statutory-forms-prescribed-under-DPCO-2013
NPPA OM dt 29-12-2022 For manufacturers and marketing companies – Implementation of prices fixed and notified under the provisions of DPCO, 2013
NPPA OM dt 28-12-2022 Fixation of ceiling Prices for Scheduled formulations (Oxygen and Nitrous Oxide for medicinal use) under Revised Schedule I (NLEM 2022) of DPCO 2013 notified vide S.O. No. 5249 (E) dated 11.11.2022
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.
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
2021
OM dt 22-11-2021- on Paragraph 28 of DPCO, 2013 regarding refusal to sell drugs by manufacturers
NPPA OM dt 30-09-2021 increase in GST rate – Medical Devices
NPPA Office Memorandum 03-08-2021 – Submission of price related information for Knee Implants.
NPPA Office Memorandum dt 23-07-2021 – for Revised MRPs in pursuance to the TMR Notification for 5 Medical Devices
NPPA Office Memorandum dt 05-07-2021 – On Ceiling or Retail Price for Amphotericin B (Emulsion) Injection 50mg.
NPPA Dt 09-06-2021 – Office Memorandum -Revised MRP for Oxygen Concentrators
NPPA Office Memorandum dt 04-06-2021 In pursuance to the Notification dated 03.06.2021 for Oxygen Concentrators
NPPA order dt 03-06-2021 Price Cap for Oxygen Concentrator through Trade Margin Rationalisation Approach
NPPA Office Memorandum dt 15-05-2021 for call of MRP Data for Pulse Oximeter & Oxygen Concentrator 2021
NPPA Office memorandum dt 17-04-2021 List of Reduced Prices of Remdesivir of 7 companies
NPPA 12-04-2021 Remdesivir-Contact Details and Helpline Numbers for availability
NPPA Office Memorandum dt 18-03-2021 – Movement in Wholesale Price Index (WPI) for the preceding calendar year 2020
NPPA Addendum dt 12-03-2021 – Monitoring of MRPs for Medical Devices dated 16.02.2021 with Annexures
NPPA dt 18-02-2021 – Display of draft version of proposed price calculation sheet for 24 proposed retail price – based on June, 2020 Data under Para 4 of DPCO, 2013
NPPA Office Memorandum dt 16-02-2021 on Monitoring of MRPs for Medical Devices with Annexures
NPPA Memorandum dt 11-01-2021 – Provisional List of 324 Over Charging cases under litigation
2020
Office memorandum dt 25-09-2020 – Clarification regarding revision of Ceiling Prices of Orthopaedic Knee Implants for the year 2020
NPPA order dt 24-09-2020 – for submission of data by manufacturers and re-fillers of medical oxygen
NPPA Office memorandum dt. 14-08-2020 Guidelines for Discontinuation of Scheduled Formulation
NPPA Order dated 25.03.2020 to maintain stock of Lopinavir and Ritonavir Tablets
NPPA – Form-IV Performa
NPPA Policy
NPPA – National Pharmaceutical Pricing Policy 2012
NPPA-National-Pharmaceutical-Pricing-Policy-2012
NPPA – Pharmaceutical Policy 2002
NPPA-Pharmaceutical-Policy-2002
NPPA – Drug Policy Amendment 1986
NPPA-Drug-Policy-Amendment-1986
NPPA – Drug policy 1986
NPPA Guidelines
NPPA Guidelines dt 07-10-2016 Regarding identification and initiating action for recovery in cases of overcharging
NPPA Guidelines dt 08-10-2013 Regarding amendment in guidelines dated 09-1-2012
NPPA Guidelines dt 08-10-2013 Regarding amendment in guidelines dated 09-1-2012
NPPA Guidelines dt 09-10-2012 Regarding dealing with overcharging and without price approval (WPA) cases
NPPA Guidelines dt 04-10-2012 Regarding referring the case for prosecution under para 8 of DPCO 1995
NPPA Guidelines dt 04-10-2012 Regarding referring the case for prosecution under para 8 of DPCO 1995
Delegation of powers
S.O. 1249(E) dt. 06-04-2020 – Delegation of Powers under DPCO 2013
S.O.-1249E-dt.-06-04-2020-Delegation-of-Powers-under-DPCO-2013
S.O. 1394(E) dt. 30-05-2013 – Delegation of Powers under DPCO 2013
S.O.-1394E-dt.-30-05-2013-Delegation-of-Powers-under-DPCO-2013
PMRU
PMRU Guidelines
NPPA issues guidelines for setting up a Price Monitoring and Resource Unit (PMRU), click the below link:
PMRU Guidelines 2020
NPPA-PMRU-Guidelines-2020-for-setting-up-Price-Monitoring-and-Resource-Unit
PMRU Guidelines 2019
NPPA-PMRU-Guidelines-2019-for-setting-up-Price-Monitoring-and-Resource-Unit
PMRUs Dashboard
NPPA – All PMRU Societies Dash Board as on 26-09-2022, click below link:
NPPA-All-PMRU-Societies-Dash-Board-as-on-26-09-2022
Latest notifications on NPPA / DPCO
Source: NPPA Website
Compiled by:
Rakesh Dahiya, SDCO cum Licensing Authority, FDA Haryana
Latest on National Pharmaceutical Pricing Authority (NPPA)
Latest notifications – DPCO / NPPA
NPPA updated price lists: Download
Latest Notifications: EC Act (Essential Commodities Act)
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