25-Nov-2022: Union Minister of State for Health, Dr. Bharati Pravin Pawar presents India’s national statement on combating Anti-Microbial Resistance (AMR) at Third Global High-Level Ministerial Conference on Antimicrobial Resistance

“Government of India has identified Anti-Microbial Resistance (AMR) as a key priority in its National Health Policy, 2017. We have taken series of initiatives which strive to build systems to counter AMR holistically". This was stated by Union Minister of State for Health & Family Welfare Dr. Bharti Pravin Pawar in India’s national statement on combating Anti-Microbial Resistance at the Third Global High-Level Ministerial Conference on Antimicrobial Resistance at Muscat, Oman.

Speaking on the occasion, MoS Health elucidated that India’s example of prioritizing the development and implementation of State Action Plans for Containment of Antimicrobial Resistance to ensure effective containment of AMR across sectors at this cutting-edge level, is a best practice that can be further discussed and emulated by other countries.

Dr. Pawar elaborated that India’s National Action Plan for containment of AMR (NAP-AMR) was officially released on 19th April 2017. The Delhi Declaration on AMR, which is an inter-ministerial consensus, was signed at the launch of NAP-AMR, by the ministers of the concerned ministries pledging their whole-hearted support in AMR containment.

MoS Health emphasized that “The National Action Plan for containment of AMR focuses on an integrated One Health approach and involves coordination among various sectors at the state, national and international level”.

Furthermore, MoS Health said National Action Plan for containment of AMR serves to leverage the strengths of various institutions such as National Center for Disease Control, Indian Council Medical Research to coordinate AMR surveillance lab networks, monitor antimicrobial consumption in health facilities, strengthen infection prevention and control, and promote antimicrobial stewardship to optimize use of antimicrobials. Food safety is monitored by The Food Safety Standards Authority of India. Similarly, Indian Network for Fisheries and Animal Antimicrobial Resistance monitor AMR in the animal sector.

The Minister concluded her speech urging all governments and partners to collaborate at the international, national and sub-national levels to tackle the development challenge posed by AMR as one family in consonance with the motto of Vasudhaiva Kutumbakam ‘One Earth, One Family, One Future’ of India’s upcoming G20 presidency.

24-Nov-2022: Dr. Bharati Pravin Pawar, Union Minister of State for Health participates in the Third Global High-Level Conference on Anti-Microbial Resistance in Muscat, Oman.

“AMR is a silent and invisible pandemic that cannot be overshadowed by other competing public health priorities”, Union Minister of State for Health & Family Welfare, Dr Bharati Pravin Pawar said as she spoke at the ministerial plenary panel of the Third Global High-Level Conference on Anti-Microbial Resistance today in Muscat, Oman. 22 participants from more than 15 countries attended the conference. The event witnessed the launch of Multi-Stakeholder Partnership Platform on AMR by the Quadripartite Organizations.

Emphasizing the prevalence of AMR and its subsequent fatal effects, she highlighted that AMR is recognized as global health threat with serious health, political and economic implications.

Dr. Pawar congratulated the UN General Assembly, WHO & member states on their focus on AMR, and said, “It is heartening to note that AMR has already been prioritized by UN General Assembly, WHO & member states” and also praised the aligned efforts by Quadripartite [FAO], [WHO], World Organization for Animal Health [WOAH] and UN Environment Programme [UNEP].

Focusing on the steps taken by India in battling AMR, MoS Health stated that under the leadership of Prime Minister Shri Narendra Modi, various initiatives have been taken to address AMR. India organized an AMR conference in 2016 at New Delhi. She highlighted that countering AMR features prominently on the national health agenda and further mentioned that various initiatives undertaken by way of awareness & capacity building, laboratory strengthening, surveillance, infection prevention & control, antimicrobial stewardship and research on newer drugs, diagnostics and innovations have garnered political will at the highest level.

MoS Health accentuated the collaboration of Health Ministers of 11 Member States had signed the Jaipur Declaration on AMR in 2011, signifying their commitment and political support towards One Health approach for containment of AMR.

Dr. Pawar also propelled further action must be taken to synergize the momentum initiated by Global AMR Conference presently and upcoming high-level meeting on AMR at the United Nations General Assembly in 2024, which will serve to strengthen the political support at all levels.

Also present on this occasion were Dr. Tedros Adhanom Ghebreyesus, WHO Director-General, QU Dongyu, Director-General of Food and Agriculture Organization of the United Nations, Dr. Hilal Al Sabti, Minister of Health of Sultanate of Oman, Saoud Al Habsi, Minister of Agriculture, Fisheries Wealth and Water resources of Sultanate of Oman, and Ernst Kuipers, Minister of Health, Welfare and Sports, Netherlands, and other dignitaries also attended the event.

5-Aug-2022: Measures taken to address challenges posed by anti-microbial resistance (AMR) in India

Government is aware about the challenges posed by anti-microbial resistance (AMR) in India and has taken following measures to address the issue:

1. AMR surveillance network has been strengthened by establishing labs in State Medical College. 36 sites in 26 States/UTs have been included in this network so far.
2. National action plan on containment of Antimicrobial Resistance (NAP-AMR) focusing on One Health approach was launched in April 2017 with the aim of involving various stakeholder ministries/departments. Delhi Declaration on AMR– an inter-ministerial consensus was signed by the ministers of the concerned ministries pledging their support in AMR containment.
3. AMR Surveillance Network: ICMR has established AMR surveillance and research network (AMRSN) comprising 30 tertiary care hospitals, both private and government to generate evidence and capture trends and patterns of drug resistant infections in the country.
4. AMR Research & International Collaboration: ICMR has taken initiatives to develop new drugs /medicines through international collaborations in order to strengthen medical research in AMR.

• ICMR along with Research Council of Norway (RCN) initiated a joint call for research in antimicrobial resistance in 2017.
• ICMR along with Federal Ministry of Education and Research (BMBF), Germany has a joint Indo-German collaboration for research on AMR.

Government of India has taken following initiatives to increase awareness about antibiotics misuse:

1. ICMR has initiated antibiotic stewardship program (AMSP) on a pilot project basis in 20 tertiary care hospitals across India to control misuse and overuse of antibiotics in hospital wards and ICUs.
2. DCGI has banned 40 fixed dose combinations (FDCs) which were found inappropriate.
3. ICMR worked in collaboration with Indian Council of Agriculture Research, Department of Animal Husbandry, Dairy and Fisheries and the DCGI to ban use of Colistin as growth promoter in animal feed in poultry.
4. Various IEC activities like public conclave, poster and quiz competitions have been conducted by National Centre for Disease Control (NCDC) in schools, colleges and Health melas to create awareness about AMR, its containment & prevention and judicial use of antibiotics among the common public.
5. To raise awareness among the community and the health care providers, communication material includes posters, videos and radio jingles has been developed with emphasis on prevention of irrational use of antibiotics during viral-illnesses and also on infection prevention through hand hygiene to prevent spread of infections.

1-Apr-2022: Steps Taken To Tackle Antimicrobial Resistance

Antimicrobial resistance is a multifaceted problem with significant consequences for individuals as well as Health Care Systems. To capture the trends and pattern of AMR in India, ICMR has established an AMR surveillance and research network (AMRSN) in 2013 to monitor data on the trends and patterns of antimicrobial resistance of clinically important bacteria and fungi limited to human health from 30 tertiary hospitals. ICMR publishes this data annually and the reports are available on ICMR website.

https://main.icmr.nic.in/sites/default/files/guidelines/AMRSN_annual_report_2020.pdf

Further, The National AMR Surveillance reports for 2019 and 2020 generated under the National programme on AMR Containment, show no significant difference in the AMR trends.

Ministry of Health and Family Welfare has taken several steps to address the issue of AMR. Some of the steps are:

• National programme on AMR containment was launched during 12th FYP in 2012-17 and coordinated by National Centre for Disease Control (NCDC). Under this programme National AMR surveillance network for capacity building of State medical college labs has been established.
• National action plan on containment of Antimicrobial Resistance (NAP-AMR) was launched in 19th April 2017
• National Treatment Guidelines: Guidelines for antimicrobial use in infectious diseases have been developed.

23-Jul-2021: Measures Taken to Rising Anti-Microbial Resistance in the Country

The Union Government of India, aware about the challenges posed by anti-microbial resistance (AMR) in the country, has taken following measures to address the issue:

• National programme on AMR containment was launched during 12th FYP in 2012-17. Under this programme, AMR Surveillance Network has been strengthened by establishing labs in State Medical College. 30 sites in 24 states have been included in this network till 30th March 2021.
• National Action Plan on Antimicrobial Resistance (NAP-AMR) focusing on One Health approach was launched on 19th April 2017 with the aim of involving various stakeholder ministries/departments. Delhi Declaration on AMR– an inter-ministerial consensus was signed by the ministers of the concerned ministries pledging their support in AMR containment.  In the line with NAP-AMR three states have launched their state action plan
  • Kerala has launched KARSAP
  • Madhya Pradesh has launched MP-SAPCAR
  • Delhi has launched SAPCARD
• AMR Surveillance Network: ICMR has established AMR surveillance and research network (AMRSN) in 2013, to generate evidence and capture trends and patterns of drug resistant infections in the country. This network comprises of 30 tertiary care hospitals, both private and government.
• AMR Research & International Collaboration: ICMR has taken initiatives to develop new drugs /medicines through international collaborations in order to strengthen medical research in AMR.
  • ICMR along with Research Council of Norway (RCN) initiated a joint call for research in antimicrobial resistance in 2017.
  • ICMR along with Federal Ministry of Education and Research (BMBF), Germany has a joint Indo-German collaboration for research on AMR.
• Initiatives to control overuse or misuse of antibiotics:
  • ICMR has initiated antibiotic stewardship program (AMSP) on a pilot project basis in 20 tertiary care hospitals across India to control misuse and overuse of antibiotics in hospital wards and ICUs.
  • On the recommendations of ICMR, DCGI has banned 40 fixed dose combinations (FDCs) which were found inappropriate.
  • ICMR worked in collaboration with  Indian Council of Agriculture Research, Department of Animal Husbandry, Dairy and Fisheries and the DCGI to ban use of Colistin as growth promoter in animal feed in poultry.
• Guidelines issued
  • National Guidelines for Infection Prevention and Control in Healthcare Facilities have been released by MoHFW in Jan 2020. (https://ncdc.gov.in/showfile.php?lid=431)
  • ICMR has developed evidence based treatment guidelines for treatment of ten syndromes of infections. It aims to rationalize the usage of antibiotics on Essential Medicines Formulary (EMF) and to establish consistency in the treatment of various infectious conditions.
  • Further, ICMR has also issued the Treatment Guidelines for Antimicrobial Use in Common Syndromes” in 2019. (https://www.icmr.nic.in/sites/default/files/guidelines/Treatment_Guidelines_2019_Final.pdf)
• IEC Activities

Media material has been developed to create awareness among various stakeholders regarding AMR and appropriate use of antibiotics.

Yes. Government is working on One Health approach by encouraging interdisciplinary collaboration at the human-animal-environmental interface.

The key priority areas include zoonotic diseases (emerging and re-emerging), food safety and antibiotic resistance.

Program for Strengthening Inter-sectoral Coordination for Prevention and Control of Zoonotic Diseases’ was launched in the 12th Five-year plan (2012-17) which is still continuing as “National One Health Program for Prevention and Control of Zoonoses” in 15th Finance Commission (2021-26) period.

This scheme aims to operationalize “One Health” Mechanisms for prevention and control of Zoonoses by strengthening inter-sectoral coordination among all stakeholders. In this regard, National Institute of One Health is being established at Nagpur  which will house  BSL IV laboratory.

ICMR has undertaken a project on an “Integrated One Health Surveillance Network for Antimicrobial Resistance” in collaboration with Indian Council of Agriculture research (ICAR) to assess the preparedness of Indian Veterinary laboratories to participate in integrated AMR surveillance network. ICMR has also created veterinary standard operating procedure (Vet-SOPs) for enabling comparison of antimicrobial resistance patterns in animals and humans. (https://main.icmr.nic.in/sites/default/files/guidelines/SOP_Bacteriology_Veterinary_2019.pdf)

9-Mar-2021: Anti-Microbial Resistance Crisis

Government of India has given due cognizance to the problem of Antimicrobial Resistance (AMR).  Ministry of Health and Family Welfare (MoHFW) has initiated various activities for containment of AMR as under  :-

1. National Action Plan for containment of Antimicrobial Resistance (NAP-AMR) was launched on 19th April, 2017, involving stakeholders from various ministries / sectors.
2. National Programme on Containment of AMR was initiated during the 12th Five Year Plan.  National Centre for Disease Control (NCDC) coordinates this programme.  Under the programme National AMR surveillance network of state medical colleges, labs(NARS-Net) have been established in order to generate quality data on AMR for seven priority bacterial pathogens of public health importance using WHONET software.
3. National Guidelines on Infection, Prevention and Control in Healthcare facilities were released in Jan, 2020. These guidelines have been shared with various stakeholders across the country to be used in training modules for country-wide trainings in a systematic manner.
4. Under the programme, NCDC conducts AMR surveillance through a network of 30 state medical college laboratories in 25 states. The network is expanded across the country in a phased manner.
5. Indian Council of Medical Research (ICMR) coordinates another AMR surveillance network of 20 laboratories located in tertiary care centres (both public and private) in the country.
6. Antimicrobial stewardship (AMSP) activities: In order to promote rational use of antibiotics among the healthcare providers, a series of sensitization and training workshops have been organized in different healthcare facilities in the country for the benefit of the practicing clinicians. Standard treatment guidelines developed by NCDC for rational use of antibiotics have been made available to clinicians across the country.
7. To create awareness among the public about AMR, various IEC activities like quiz competition in schools, participation in Perfect Health Mela, poster & quiz competition for healthcare workers at NCDC and the sites included in the NARS-Net during World Antibiotic awareness each year have been conducted to raise awareness about AMR. IEC material (audio /video /Print OD Media) to raise awareness about AMR and to prevent misuse of antibiotics has been made available on the website of NCDC for use by the States-UT governments and other stakeholders.

As per Ministry of Environment Forest and Climate Change, draft notification on emission and discharge standards for Bulk Drug and Formulation (Pharmaceutical) Industries was notified on 23.01.2020.  According to the ministry, thirty five suggestions were received from the associations, NGOs, individual experts and industry.  Stakeholders consultation were made.  Necessary information and research is not available for prescribing the appropriate norms for limiting the concentration of antibiotics, monitoring and compliance verification and testing protocols for effluents discharged from pharma industry.

18-Jun-2019: WHO offers a new tool to accelerate action against antimicrobial resistance

WHO launched a global campaign urging governments to adopt a tool to reduce the spread of antimicrobial resistance, adverse events and costs.

The AWaRe tool was developed by the WHO Essential Medicines List to contain rising resistance and make antibiotic use safer and more effective. It classifies antibiotics into three groups – Access, Watch and Reserve – and specifies which antibiotics to use for the most common and serious infections, which ones should be available at all times in the healthcare system, and those that must be used sparingly or preserved and used only as a last resort.

The new campaign aims to increase the proportion of global consumption of antibiotics in the Access group to at least 60%, and to reduce use of the antibiotics most at risk of resistance from the Watch and Reserve groups. Using Access antibiotics lowers the risk of resistance because they are ‘narrow-spectrum’ antibiotics (that target a specific microorganism rather than several). They are also less costly because they are available in generic formulations.

Antimicrobial resistance is one of the most urgent health risks of our time and threatens to undo a century of medical progress. All countries must strike a balance between ensuring access to life-saving antibiotics and slowing drug resistance by reserving the use of some antibiotics for the hardest-to-treat infections. Countries should adopt AWaRe, which is a valuable and practical tool for doing just that.

Antimicrobial resistance is a global health and development threat that continues to escalate globally, as highlighted in a recent report by the International Coordination Group on Antimicrobial Resistance. Currently, it is estimated that more than 50% of antibiotics in many countries are used inappropriately such as for treatment of viruses when they only treat bacterial infections or use of the wrong (broader spectrum) antibiotic, thus contributing to the spread of antimicrobial resistance.

One of the most pressing concerns is the spread of resistant gram-negative bacteria, including Acinetobacter, Escherichia coli and Klebsiella pneumoniae. These bacteria, which are commonly seen in hospitalized patients, cause infections like pneumonia, bloodstream infections, wound or surgical site infections and meningitis. When antibiotics stop working effectively, more expensive treatments and hospital admissions are needed, taking a heavy toll on already stretched health budgets.

At the same time, many low and middle-income countries experience vast gaps in access to effective and appropriate antibiotics. Childhood deaths due to pneumonia (estimated globally at close to one million per year) because of lack of access to antibiotics remain frequent in many parts of the world. And although over 100 countries have put in place national plans to tackle antimicrobial resistance, only about one fifth of those plans are funded and implemented.

Tackling antimicrobial resistance requires a careful balance between access and preservation. The AWaRe tool can guide policy to ensure patients keep being treated, while also limiting use of the antibiotics most at risk of resistance.

In the absence of new significant investments into the development of new antibiotics, improving the use of antibiotics is one of the key actions needed to curb further emergence and spread of antimicrobial resistance. By classifying antibiotics into three distinct groups, and advising on when to use them, AWaRe makes it easier for policy-makers, prescribers and health workers to select the right antibiotic at the right time, and to protect endangered antibiotics.

Antimicrobial resistance is an invisible pandemic. We are already starting to see signs of a post-antibiotic era, with the emergence of infections that are untreatable by all classes of antibiotics. We must safeguard these precious last-line antibiotics to ensure we can still treat and prevent serious infections.

29-Apr-2019: Drug-resistant diseases could cause 10 million deaths each year by 2050

According to a groundbreaking report, the UN Ad hoc Interagency Coordinating Group on Antimicrobial Resistance warned that if no action is taken, drug-resistant diseases could cause 10 million deaths each year by 2050 and damage to the economy as catastrophic as during the 2008-2009 global financial crisis. By 2030, antimicrobial resistance could force up to 24 million people into extreme poverty.

Currently, at least 700,000 people die each year due to drug-resistant diseases, including 230,000 people who die from multidrug-resistant tuberculosis.

More and more common diseases, including respiratory and urinary tract infections, as well as sexually transmitted infections, are untreatable; lifesaving medical procedures are becoming much riskier, and our food systems are increasingly precarious.

“We are at a critical point in the fight to protect some of our most essential medicines,” said Tedros Adhanom Ghebreyesus, WHO Director-General and Co-Chair of the IACG. “This report makes concrete recommendations that could save thousands of lives every year.”

The world is already feeling the economic and health consequences as crucial medicines become ineffective. Without investment from countries in all income brackets, future generations will face the disastrous impacts of uncontrolled antimicrobial resistance.

Recognizing that human, animal, food and environmental health are closely interconnected, the report calls for a coordinated, multisectoral ‘One Health’ approach.

It recommends countries:

• prioritize national action plans to scale-up financing and capacity-building efforts;
• put in place stronger regulatory systems and support awareness programs for responsible and prudent use of antimicrobials by professionals in human, animal and plant health;
• invest in ambitious research and development for new technologies to combat antimicrobial resistance; and
• urgently phase out the use of critically important antimicrobials as growth promoters in agriculture.

The report highlights the need for coordinated and intensive efforts to overcome antimicrobial resistance: a major barrier to the achievement of many of the UN Sustainable Development Goals (SDGs), including universal health coverage, secure and safe food, sustainable farming systems and clean water and sanitation.

12-Sep-2022: Tata Memorial’s study suggests simple, low-cost intervention to significantly increase breast cancer cure rate and survival rate

Dr Rajendra Badwe, Director, Tata Memorial Centre, Mumbai today presented the results of a landmark multi-centre Indian study on breast cancer. The results of this study show that this simple, low-cost intervention significantly and substantially increases the cure rates and survival of breast cancer patients, with a benefit that is ongoing for several years after surgery. The injection requires no additional expertise, is inexpensive, and can result in saving up to 100,000 lives annually globally. These benefits are substantial and were achieved with an intervention the cost of which was less than Rs.100/- per patient. For comparison, benefits of far lesser magnitude have been achieved in early breast cancer patients by much more expensive, targeted drugs which cost more than ten lakhs per patient. The clinical trial is hence an important milestone in the treatment of breast cancer. The trial in women undergoing breast cancer surgery involved the injection of a commonly used drug around the tumour, on the operating table, just prior to surgery.

Dr. Badwe presented these findings at the ongoing European Society of Medical Oncology (ESMO) Congress in Paris, one of the most prestigious cancer conferences in the world held annually in Europe. A press conference to announce the results of the trial was arranged today, simultaneously with the live streaming of the presentation, followed by the address by Dr. Sudeep Gupta, Professor of Medical Oncology, Tata Memorial Centre/Hospital & Homi Bhabha National Institute and Director, ACTREC.

Joining from Paris immediately after his presentation, Dr Badwe commented, "This is the first study of its kind globally, that has shown a sizable benefit by single intervention prior to surgery. If implemented across the world, it has the capability to save over 100,000 lives annually. For scientists, it opens the window of peri-operative intervention to modulate the environment of cancer in such a way as to prevent its deleterious reaction to the act of surgery [observation]. Evolving low-cost interventions for cancer has been a mission of Tata Memorial Centre and Department of Atomic Energy for the benefit of Indian and global population and this study, supported by the Department of Atomic Energy, is a major step towards Atma Nirbhar Bharat."

Dr Sudeep Gupta, Professor of Medical Oncology at TMC and Director ACTREC, one of the co-investigators of the study said, “This study provides an inexpensive and immediately implementable treatment in breast cancer which can be practiced by every surgeon who treats this disease. The results from a large randomized trial, which is the gold-standard way of evaluating the worth of new treatments, provides the highest level of evidence to support the use of this technique. This study is proof that Indian centres can design and conduct studies which have a global impact.”

The study, ‘Effect of Peri-tumoral Infiltration of Local Anaesthetic Prior to Surgery on Survival in Early Breast Cancer’ is a randomized controlled trial, conceived and designed by Dr Badwe, who is the principal investigator. The study was conducted by investigators at 11 cancer centres in India including Tata Memorial Centre in Mumbai over an 11-year period between 2011 and 2022.

The study included 1,600 women with early breast cancer who were planned to be treated with surgery. Half of these patients, constituting the control group, received standard surgery followed by standard post-operative treatment including chemotherapy, hormone therapy and radiotherapy as per guidelines. The other half, constituting the intervention group, received an injection of a commonly used local anaesthesia agent, 0.5% lidocaine, all around the tumor, just prior to surgery. They then underwent standard surgery followed by the same postoperative treatment as was given in the control group.

Dr Badwe’s previous research has suggested that there is a window of opportunity just prior to, during, and immediately after surgical removal of the primary cancer when anti-cancer interventions could reduce the risk of development of disseminated stage 4 metastatic cancer later in the lifespan of the patient. Lignocaine, which is a commonly used, inexpensive, local anesthesia drug, was thought to be one such suitable intervention because of its inhibitory effects on cancer cell division, movement and other anti-cancer properties. Depicted here is the diagrammatic representation of the technique of peri-tumoral injection which is simple and requires no additional expertise.

After completion of treatment patients were followed up regularly for several years to compare the rates of cure and survival between the control group and local Anaesthesia group. When enough follow-up had happened in both groups the data was analysed at a cut-off date of September 2021. As expected, there was no toxicity of lignocaine in patients who received it. The 6-year disease-free survival (cure rate) was 81.7% in the control group and 86.1% in the local Anaesthesia group for a 26% relative reduction in the risk of cancer relapse or death with the local Anaesthesia injection, which was statistically significant. Similarly the 6-year overall survival was 86.2% versus 89.9% in the two groups for a 29% reduction in the risk of death with the local anaesthetic injection, which was also statistically significant. Depicted below are the disease-free survival and overall survival in the two study groups over time.

18-Dec-2019: WHO prequalifies first biosimilar medicine to increase access to breast cancer treatment

World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab – in a move that could make this expensive, life-saving treatment more affordable and available to women globally.

Breast cancer is the most common form of cancer in women. 2.1 million women contracted breast cancer in 2018. 630 000 of them died from the disease, many because of late diagnosis and lack of access to affordable treatment.

Trastuzumab – a monoclonal antibody – was included in the WHO Essential Medicines List in 2015 as an essential treatment for about 20% of breast cancers. It has shown high efficacy in curing early stage breast cancer and in some cases more advanced forms of the disease.

Women in many cultures suffer from gender disparity when it comes to accessing health services. In poor countries, there is the added burden of a lack of access to treatment for many, and the high cost of medicines. Effective, affordable breast cancer treatment should be a right for all women, not the privilege of a few.

The global average cost of trastuzumab from originator companies is $20 000, a price that puts it out of reach of many women and healthcare systems in most countries. The biosimilar version of trastuzumab is generally 65% cheaper than the originator. With this WHO listing, and more products expected in the prequalification pipeline, prices should decrease even further.

The medicine, supplied by Samsung Bioepis NL B.V. (Netherlands), was assessed by WHO and found comparable to the originator product in terms of efficacy, safety and quality. That means it is eligible for procurement by United Nations agencies and for national tenders.

Biotherapeutic medicines, which are produced from biological sources such as cells rather than synthesized chemicals, are important treatments for some cancers and other non-communicable diseases. Like generic medicines, biosimilars can be much less expensive versions of innovator biotherapeutics while keeping the same effectiveness. They are usually manufactured by other companies once the patent on the original product has expired.

A few biosimilars of trastuzumab have come to market in the last five years, but none had been prequalified by WHO before today. WHO prequalification gives countries the assurance that they are purchasing quality health products.

A recent study of breast cancer in sub-Saharan Africa found that of 1325 women surveyed in three countries, cancer treatment had not been initiated within one year of diagnosis for 227 (17%) women and for 185 (14%) women with stage I-III disease. Self-reported treatment barriers confirmed treatment costs as a major contributor to not receiving treatment.

WHO’s International Agency for Research on Cancer estimates that by 2040 the number of diagnosed breast cancers will reach 3.1 million, with the greatest increase in low- and middle-income countries.

Biotherapeutics: Biotherapeutics are pharmaceutical products derived from biological and living sources. They include therapeutic vaccines, blood, blood components, cells, gene therapies, tissues and other materials. Several biologic medicines are ‘specialty drugs’, highly priced and effective in treating medical conditions for which no other treatments are available. Gene- and cell-based therapies are among these pharmaceuticals. Some biotherapeutics are effective treatments for certain forms of cancer, chronic diseases such as diabetes, Crohn’s disease and other autoimmune conditions, including lupus, and various forms of rheumatoid arthritis.

WHO Prequalification: Every year, billions of dollars’ worth of medicines and other health products are purchased by international procurement agencies for distribution in low-income countries. Prequalification is a service provided by WHO to assess the quality, safety and efficacy of those products that address global public health priorities. If the products meet international standards, they are listed on the WHO web site as eligible for procurement, giving purchasing agencies a range of quality-assured diagnostics, medicines and vaccines from which to choose. Many low-income countries also use WHO’s lists of prequalified products to guide their selection of medicines, vaccines and technologies for national procurement.

In July 2018, WHO launched a pilot project expanding the scope of prequalification to two biotherapeutic medicines, as a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. This is the first biotherapeutic to be prequalified as part of the pilot.