29-Aug-2022: Dr Mansukh Mandaviya addresses Silver Jubilee Celebrations of National Pharmaceutical Pricing Authority

Union Minister of Chemical and Fertilizers, Dr. Mansukh Mandaviya addressed the Silver Jubilee Celebrations of National Pharmaceutical Pricing Authority (NPPA), here today. Shri Bhagwanth Khuba, Minister of State for Chemicals & Fertilizers and New & Renewable Energy graced the occasion as guest of honour.

Addressing the event, Dr Mandaviya congratulated NPPA for working more as a facilitator, not merely as a regulator. He highlighted their noteworthy contribution towards ensuring availability and affordability of medicines in the last 25 years.

The Union Minister also praised the Indian Industries for continuously producing quality products. He urged them to produce medicines and bring innovative research with the goal of ensuring good health and well-being of the people, not only for commercial purpose.

Dr Mandaviya assured Indian pharma companies of continuous support from the govt. He highlighted the PLI 1 and PLI 2 schemes for the industries, which has helped in bringing about indigenous manufacturing of many critical APIs in the country. He also recalled the positive contribution of Indian pharma companies during the Covid crisis and highlighted the importance of cooperation and collaboration between the govt and industry in bringing quality healthcare to the masses

Shri Bhagwanth Khuba praised NPPA for being in service of the country and the Pharma sector successfully for the last 25 years. He stated that “NPPA ensures availability of affordable medicines without harming the interests of the industry”. He also expressed his optimism that with the launch of the two applications today, NPPA is expected to further carry on its work in a smooth and efficient manner in the coming years”.

At the inaugural session, Integrated Pharmaceutical Database Management System 2.0 (IPDMS 2.0) and Pharma Sahi Daam 2.0 App were launched.

IPDMS 2.0 is an integrated responsive cloud based application developed by NPPA with technical support from Centre for Advance Computing (C-DAC). It is envisaged to optimize synergies in operations in order to promote Government’s thrust on ‘Ease of Doing Business’ as it would provide a single window for submissions of various forms as mandated under Drug Price Control Order (DPCO),2013. It would also enable paperless functioning of NPPA and facilitate the stakeholders to connect with National Pharma Pricing Regulator from across the country.

Pharma Sahi Daam 2.0 App will have updated features like speech recognition; availability in Hindi and English; share button and bookmarking medicines.  This version of Pharma Sahi Daam also has facility for launching complaints by consumer through the consumer complaint handling module. The App will be available in both iOS and Android versions.

A publication titled ‘An overview of Drug Pricing @ NPPA 25 year Odyssey’ was also launched at the inaugural session.  The publication chronicles not only the 25 year journey of NPPA but also highlights the evolution of the drug regulatory system in the country with special emphasis on pricing regulation.

Earlier, Shri Kamlesh Pant, Chairman, NPPA had delivered the welcome address. Ms. S Aparna, Secretary, Department of Pharmaceuticals, and Dr. Vinod Kotwal, Member Secretary, NPPA were present in the event.

Stakeholders from the pharmaceutical and MedTech devices industry, Central and State Governments, Price Monitoring and Resource Units, Civil Society, patient advocacy groups, Pharmaceutical Research and Academic Institutions, Think-Tanks and media representatives from all over the country were also present on the occasion.

27-Jul-2021: NPPA has capped the trade margin for Oxygen Concentrators at 70% on Price to Distributor (PTD) level

The National Pharmaceutical Pricing Authority (NPPA) under the Department of Pharmaceuticals, as an on-going process, with the help of Price Monitoring & Resource Units (PMRUs) and State Drug Controllers (SDCs) undertake activities related to market-based data collection, monitoring of the notified prices of medicines and detection of violation of the provisions of Drug (Price Control) Order, 2013 (DPCO, 2013).

NPPA fixes the ceiling prices of scheduled formulations as per provisions of DPCO, 2013 and monitors the prices of non-scheduled drugs so as to ensure that their prices do not increase beyond 10 percent in a year. NPPA has fixed ceiling prices of 355 medicines and 882 formulations for medicines under National List of Essential Medicines, 2015 (Schedule-I of DPCO, 2013). Most of the drugs that are part of COVID management protocol have ceiling prices, viz., Paracetamol, Dexamethasone, Methyl Prednisolone, IVIGs, Enoxaparin, Budesonide, Heparin and Amphotericin etc. In the case of few non-scheduled medicines like Remdesivir, which are part of COVID protocol and are non-scheduled, on Government intervention, MRPs of various brands of Remdesivir have been reduced voluntarily by the major manufacturers/marketers of the Remdesivir Injection (lyophilized).  Inter-brand MRPs that varied up to Rs 5400/ per vial were brought down to less than Rs 3500/-.

Furthermore, to facilitate availability and ensure affordability, NPPA has capped the trade margin for Oxygen Concentrators at 70% on Price to Distributor (PTD) level vide notification dated 3rd June, 2021 and on Pulse Oximeter, Glucometer, BP Monitor, Nebulizer and Digital Thermometer vide notification dated 13th July, 2021.

In addition, Retail prices for 1,640 formulations have been fixed under DPCO, 2013 till date and in recent years exercising extraordinary powers under DPCO, 2013 in public interest, NPPA has fixed the prices of following drugs and medical devices:

1. Ceiling price of Stents in February, 2017
2. Ceiling price of Knee Implants in August, 2017
3. Capped trade margin on selected 42 anti-cancer drugs in February, 2019.

24-Oct-2020: Price Monitoring and Resource Unit set up in Goa under the aegis of National Pharmaceutical Pricing Authority (NPPA)

A Price Monitoring and Resource Unit (PMRU) has been set up in Goa under the aegis of National Pharmaceutical Pricing Authority (NPPA), Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India.         

NPPA, in coordination with Goa State Drug Control Department has set up a Price Monitoring and Resource Unit on 22, October 2020. This PMRU will function at the State level under the direct supervision of the State Drug Controller for increasing outreach of NPPA. PMRUs are societies registered under the Societies Registration Act having its own Memorandum of Association/ Bye laws. The Board of Governors of PMRU includes the representatives from Central Government and State Government concerned and other stakeholders.

NPPA, under its Central Sector Scheme named Consumer Awareness, Publicity and Price Monitoring (CAPPM) has already   set up PMRUs in 15 States/ UTs, viz., Kerala, Odisha, Gujarat, Rajasthan, Haryana, Nagaland, Tripura, Uttar Pradesh, Punjab, Andhra Pradesh, Mizoram, Jammu & Kashmir, Karnataka, Telangana and Maharashtra.  NPPA has plans to set up PMRUs in all the 36 States/ UTs in the country.  The expenses of PMRUs, both recurring and non-recurring are borne by NPPA under the Scheme.

Till now NPPA is headquartered at Delhi and with the setting up of PMRUs in States/ UTs, NPPA shall have outreach at State Level as well.

The PMRUs are expected to strengthen drug security and affordability at regional levels.  The primary function of PMRUs is to assist NPPA in monitoring of prices of drugs, ensuring availability of drugs and raising consumer awareness. They act as collaborating partners of NPPA with information gathering mechanism at the grass-roots level. They will render necessary technical assistance to both the NPPA and the respective State Drug Controllers of States/ Union Territories.

NPPA has been working in tandem with State Governments during the COVID-19 pandemic to ensure seamless availability of life saving medicines including HCQ, paracetamol, vaccines, insulin and medicines under COVID protocol, including medical oxygen. Working together with State Governments, NPPA has strived to ensure that there is no shortage of drugs throughout the country.

29-Aug-2020: Union Ministers Shri Gowda and Shri Mandaviya complements NPPA on its 23rd Foundation Day today for playing crucial role in reasonable pricing and availability of essential medicines

On  the foundation day of  National Pharmaceuticals Pricing Authority (NPPA) Union Minister of  Chemicals  and Fertilizers Shri D.V. Sadananda Gowda  congratulated NPPA “for working tirelessly to ensure availability of life-saving drugs at reasonable prices consistently, towards the vision of Prime Minister Shri Narendra Modi for affordable health care system to all citizens”. Recognizing the crucial role being played by NPPA during COVID 19 pandemic, the  Minister also noted, "It also prevented any shortage of medicines during COVID19 and resolved Public Grievances efficiently through active Control room. Also, catered to the needs of over 120 countries by supplying critical medicines by India during COVID .

In a tweet Shri Mansukh Mandaviya, Minister of State (Independent Charge), Ministry of Shipping and Minister of State in the Ministry of Chemicals and Fertilizers acknowledged the important role being played by NPPA , “29th August is an important day for India as NPPA was founded to control the prices of essential & lifesaving medicines. NPPA is working tirelessly with the goal of Healthy Nation as envisioned by Prime Minister and is helping to save crores of rupees of common men.” NPPA is using digital technology to discharge its functions and the same was noted by MoS, NPPA is propelling Digital India mission by 1.Pharma Sahi Daam-app to check prices of medicines

Pharma Jan Samadhan-public grievance system to help people resolve their problems.

Pharma Data Bank-online information collection from Pharma manufacturers.”

On the occasion, Dr. P.D. Vaghela, Secretary, Department  of Pharmaceuticals also noted that NPPA through its recent efforts has set-up Price Monitoring and Research Units (PMRUs) for strengthening monitoring and public awareness in 13 States/UTs. He underlined the role that NPPA plays by giving key inputs to various Ministries/ Departments of Government of India on specific issues, which is important in taking decisions for policy formulation and implementation.

Speaking on the occasion, Smt. Shubhra Singh, Chairman, NPPA highlighted the fact that NPPA strives to strike a balance between the interests of the consumers and the Pharmaceutical Industry as per the ambit of the DPCOs. During its 23 years of existence, NPPA has been working towards the larger goal of a Healthy Nation by facilitating affordable health care through pricing of NLEM drugs, knee implants, stents, and more recently through the Trade Margin Rationalisation (TMR) of anti-cancer drugs that resulted in substantial annual saving to the consumers across the country.  Specifically, in the times of COVID-19 pandemic, NPPA through its Control Room worked 24 x 7 to promptly resolve issues and problems of citizens, manufacturers and marketers.

During lockdown period, it addressed the issues of supply-chain constraints of non-availability of raw material, packaging material and manpower too.

NPPA was set-up as an independent Regulator on 29th August, 1997 for pricing of drugs and to ensure availability and accessibility of medicines at affordable prices. The regulator, an attached office of the Department of Pharmaceuticals (DoP), Ministry of Chemicals & Fertilizers was created vide Government of India Resolution published in the Gazette of India number 159 dated 29th August, 1997. The functions of NPPA include fixation and revision of prices of Scheduled drugs under Drug (Price Control) Orders issued from time to time, as well as monitoring and enforcement of prices and ensuring availability and accessibility of all medicines and medical devices, including nonscheduled drugs.

2-Jul-2020: NPPA is monitoring price increase of critical medical equipments for COVID-19

In the wake of COVID-19 pandemic, Government is striving to ensure sufficient availability of critical medical equipments for clinical management of COVID-19 in the country. Ministry of Health & Family Welfare (MoH&FW) has identified list of critical medical equipments for the same and has requested National Pharmaceutical Pricing Authority (NPPA) to ensure availability of the same in the country.

The Government is committed for availability of life saving drugs/devices at affordable prices to the consumers. All the medical devices have been notified as Drugs and have come under regulatory regime of the Drugs & Cosmetics Act, 1940 and Drugs (Prices (Control Order), 2013 w.e.f. 1st April 2020. In order to keep check on the price rise of critical medical equipments, NPPA, in exercise of powers conferred under DPCO, 2013, has called for price related data from manufacturers/importers of (i) Pulse Oximeter and (ii) Oxygen Concentrator to ensure that prices existing as on 1st April 2020 should not be increased more than 10% in a year.

A Stakeholders Consultation with Medical Devices Industry Associations and Civil Society Group was held in NPPA on 1st July 2020 wherein it was stressed that all the manufacturers/importers of critical medical equipments shall ensure sufficient availability of the same in the country. It has been reiterated that all the Medical Devices have come under price regulation under DPCO, 2013 w.e.f. 1st April 2020, accordingly, price increase of medical devices would be monitored under Para 20. Chairman, NPPA also urged the Industry that it is not “Business as usual” and not the time to profiteer in the public health emergency. The Medical Devices Industry Associations have been urged to bring down the retail price of critical medical equipments in larger public interest in the prevailing situation as has been done by the manufacturers/importers of N-95 masks.

25-May-2020: Prices of N-95 Masks are getting reduced by the Importers/ Manufacturers/Suppliers of N-95 Masks after an Advisory issued by NPPA

The Government has notified N-95 Masks as an essential commodity under Essential Commodities Act, 1955 by the Government vide Notification dated 13th March 2020. Thus, hoarding, black-marketing of the essential commodity is punishable offence under the Act. To keep check on the hoarding, black-marketing of the essential commodity, NPPA in exercise of the powers conferred under National Disaster Management Act, 2005 had directed all States/ UT Governments to ensure sufficient availability of surgical and protective Masks, Hand Sanitizers and Gloves at prices not exceeding the Maximum Retail Price printed on the pack size vide Orders dated 13th March 2020.

Grievances have been received regarding hoarding, black-marketing and differential higher pricing of N-95 Masks in the country. In this context, NPPA has directed State Drug Controllers/Food & Drug Administrations of all State/ UT Governments to take appropriate actions. As reported, raids have been conducted by few SDCs/ FDAs and appropriate action is being taken against the hoarders and black-marketers of the essential commodity. A PIL has also been filed before Hon’ble High Court of Bombay on the plea of bringing price cap on the N-95 Masks by the Government.

The Government is striving to ensure uninterrupted supply of N-95 Masks in adequate quantity in the country. For this, the Government is procuring largest chunk of the N-95 Masks directly from the manufacturers/ importers/ suppliers at bulk rates. To address the issue of higher prices of the N-95 Masks, NPPA intervened to bring down the prices. In this regard, in order to ensure availability of N-95 Masks at affordable prices in the country, NPPA issued an Advisory on 21st May 2020 to all the manufacturers/ importers/ suppliers of the N-95 Masks to maintain parity in prices for non-government procurements and to make available the same at reasonable prices. Further, NPPA submitted before Hon’ble High Court of Bombay on the plea of bringing price cap on the N-95 Masks that looking to the mismatch in the demand-supply of N-95 Masks in the country, NPPA advised manufacturers/ importers/ suppliers to bring down the prices voluntarily.

Meanwhile NPPA denies the news item appeared in the Times of India today alleging that NPPA approvingly cited a price that is more than three times the government procurement rate for the masks.  The Government procurement rate quoted in the news clipping is fallacious, deceptive and misleading. 

After issuing such an Advisory, major manufacturers/ importers of N-95 Masks have reduced their prices significantly up to 47% leading to availability of N-95 Masks in the country at affordable prices. As reported by the other manufacturers/ importers of N-95 Masks, it is expected that other manufacturers/ importers will follow the advice of the Government and roll down the prices in the larger public interest.

1-Apr-2020: J&K sets up PMRU of NPPA

Jammu & Kashmir Union Territory has become 12th State  today where the Price Monitoring & Resource Unit (PMRU) has been set up by National Pharmaceutical Pricing Authority (NPPA).  PMRUs have already been set up by NPPA in 11 States, including, Kerala, Odisha, Gujarat, Rajasthan, Punjab, Haryana, Nagaland, Tripura, Uttar Pradesh, Andhra Pradesh and Mizoram.

The PMRU, a registered society, shall function under the direct control and supervision of State Drug Controller of Jammu & Kashmir.  The unit shall be funded by  NPPA for its recurring and non-recurring expenses.  The PMRU shall help NPPA and State Drug Controller in ensuring availability and accessibility of medicines at affordable prices. It is also expected to organise seminars, training programs and other information, education and communication (IEC) activities in the areas of availability and affordability of medicines for all. 

PMRU will also collect samples of medicines, collect and analyse data and make reports with respect to availability and over-pricing of medicines for taking action under the provisions of Drug Price Control Order (DPCO). This assumes added significance as PMRU, J&K will assist NPPA and Governments in checking overpricing and identifying causes & addressing local issues of shortages/hoarding in the current situation when country is fighting the COVID-19 pandemic.

17-Mar-2020: NPPA, regularly monitoring  the situations of  prices and availability  of essentials  medicines

The Minister for Chemicals & Fertilizers Shri. D.V. Sadananda Gowda informed the   Lok  Sabha  in written reply today  that NPPA is monitoring the situation regularly to ensure that ceiling prices of essential medicines are not breached and are available uninterruptedly. The Minister further informed that  National Pharmaceutical Pricing Authority (NPPA) has not received any reference regarding sudden increase in the price of paracetamol by 40 per cent and azithromycin by 70 per cent in the country. The All Indian Origin Chemists & Distributors Ltd. - Advanced Working, Action & Correction System (AIOCD AWACS) has reported increase in drug prices for month ending February, 2020 at 0.6 %.

He added that NPPA has issued D.O. dated 20.02.2020 to Chief Secretaries of all the States /UTs to monitor the production and availability of Active Pharmaceutical Ingredients (API)s  and their formulations to prevent black marketing and hoarding and to ensure price compliance as per the Drugs (Prices Control) Order, 2013 (DPCO, 2013) under intimation to the NPPA.

In reply  to another question Shri. Gowda stated that National Pharmaceutical Pricing Authority (NPPA) monitors the prices of medicines on a regular basis to check overcharging by pharmaceutical companies. Whenever any company is found to be overcharging consumers for a medicine above the ceiling price notified by the NPPA, the NPPA issues a notice to such company to deposit the overcharged amount along with applicable interest under section 7A of the Essential Commodities Act, 1955.

Minister also said that NPPA examines and considers the reply of the companies, if given, before issuing notices. The NPPA does not maintain state-wise record of overcharging by pharmaceutical companies. However, company wise detailed list of overcharging cases, where demand notices have been issued is available on the NPPA’s website www.nppaindia.nic.in.

14-Dec-2019: NPPA hikes 21 formulations’ prices by 50%

India granted a 50% increase in the prices of 21 drug formulations, including ascorbic acid (Vitamin C) tablets, certain antibiotic tablets and syrups, medicines to treat leprosy and malaria and BCG vaccines, citing higher ingredient costs.

The National Pharmaceuticals Pricing Authority (NPPA) invoked paragraph 19 of the Drug Prices Control Order, which until now has been used only to reduce the prices of stents and Knee implants.

With the cost of raw material imported from China increasing 50-200%, pharmaceutical lobby groups had approached the government to increase the prices of drugs. Over 70% of India’s bulk drug requirement comes from China. These bulk drugs or active pharmaceutical ingredients (API) are used to produce medicines, including antibiotics, vitamins and folic acid.

Most of these 21 drugs are used as the first line of treatment and are crucial to the public health programme of the country.

17-Jan-2018: NPPA fixes retail price of 30 drug formulations

Drug price regulator NPPA has fixed the retail price for 33 drug formulations, including those used for treatment of diabetes, bacterial infections and high blood pressure.

The National Pharmaceutical Pricing Authority (NPPA) has also revised the prices of three formulations, including that of anti-cancer drug -- Gemcitabine.

NPPA has fixed/revised ceiling prices/retail prices of 33 formulations under Drugs (Prices Control) Order, 2013.

The NPPA is mandated to fix/revise the prices of controlled bulk drugs and formulations and to enforce prices and availability of the medicines in the country. It also monitors the prices of decontrolled drugs in order to keep them at reasonable levels. The regulator implements and enforces the provisions of the Drugs (Prices Control) Order. It is also entrusted with the task of recovering amounts overcharged by manufacturers for the controlled drugs from the consumers.

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2-Aug-2022: Import and domestic production of APIs

The Indian Pharmaceutical industry is the 3rd largest in the world by volume. India is one of the major producers of Active Pharma Ingredients (API) or bulk drugs in the world. India exported Bulk Drugs/Drug Intermediates worth Rs. 33,320 crore in financial year 2021-22. However, the country also imports various Bulk Drugs/APIs for producing medicines from various countries and most of the imports of the Bulk Drugs/APIs being done in the country are because of economic considerations. India imported Rs. 35,249 crore worth APIs and Bulk drugs in 2021-22. 

In order to make the country Atmanirbhar in APIs and drug intermediates, the Department of Pharmaceuticals is implementing the following three schemes by attracting large investments in the sector to ensure their sustainable domestic supply and thereby reduce India’s import dependence on other countries: -

1. The Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) in India, with a financial outlay of Rs. 6,940 crores and the tenure from FY 2020-2021 to FY 2029-30, provides for financial incentive for 41 identified products. A total of 51 applicants have been selected under the scheme.
2. The Production Linked Incentive Scheme for Pharmaceuticals, with a financial outlay Rs. 15,000 crores and the tenure from FY 2020- 2021 to FY 2028-29, provides for financial incentive to 55 selected applicants for manufacturing of identified products under three categories for a period of six years. The eligible drugs under this scheme include APIs.
3. The Scheme for Promotion of Bulk Drug Parks, with a financial outlay of Rs. 3,000crores and the tenure from FY 2020-2021 to FY 2024-25, provides for financial assistance to three States for establishing Bulk Drug Parks.