This guideline is intended to provide recommendations to applicants wishing to submit applications for the registration of medicines. It represents the Medicines Control Council’s current thinking on the safety, quality and efficacy of medicines.
This document provides additional guidance for the responsible and prudent use of antimicrobials in food-producing animals, and should be read in conjunction with the Recommended International Code of Practice for Control of the Use of Veterinary Drugs CAC/RCP 38-1993. Its objectives are to minimize... the potential adverse impact on public health resulting from the use of antimicrobial agents in food-producing animals, in particular the development of antimicrobial resistance.
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac...ovigilance centre. Throughout this document, the phrase “consumer reporting” is used to refer to reporting of adverse drug reactions (ADRs) by the general public.
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In Kenya, the bacterial infections that contribute most to human disease are often those in which re-‐sistance is most evident. Examples are multidrug-‐resistant enteric bacterial pathogens such as typhoid, ... diarrhoeagenic Escherichia coli and invasive non-‐typhi salmonella, penicillin-‐resistant Streptococcus pneu-‐moniae, vancomycin-‐resistant enterococci, methicillin-‐resistant Staphylococcus aureus and multidrug-‐re-‐sistant Mycobacterium tuberculosis. Resistance to medicines commonly used to treat malaria is of particu-‐lar concern, as is the emerging resistance to anti-‐HIV drugs. Often, more expensive medicines are required to treat these infections, and this becomes a major challenge in resource-‐poor settings.
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Pakistan Global Antibiotic Resistance Partnership (GARP) was formed in the wake of international and national efforts for AMR curtailment. A group of experts from microbiology, infectious diseases and veterinary medicine formed a core group at the organizational meet...ing of GARP in Kathmandu, Nepal in July 2016. In the meeting, this core group was expanded to include other members from different sectors with the selection of the Chair and co-chairs. These were asked to serve on a voluntary basis, in their own individual capacities, with no personal gains, or gains to the institutions to which they are affiliated. The first phase of GARP took place from 2009 to 2011 and involved four countries: India, Kenya, South Africa and Vietnam. Phase one culminated in the 1st Global Forum on Bacterial Infections, held in October 2011 in New Delhi, India. In 2012, phase two of GARP was initiated with the addition of working groups in Mozambique, Tanzania, Nepal and Uganda. Phase three has added Bangladesh, Lao PDR, Nigeria, Pakistan and Zimbabwe to the network to date.
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The Ebola outbreak that started in December 2013 became a public
health, humanitarian and socioeconomic crisis with a devastating
impact on families, communities and affected countries. It also served
as a reminder that the world, including WHO, is ill-prepared for a large
and sustained disease ...outbreak.
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at six sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospita...ls in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Antimicrobial Resistance and our Food Systems - Challenges and Solutions
SITUATION ANALYSIS AND RECOMMENDATIONS
(Health Systems in Transition, Vol. 4, No. 3, 2014)
The issue of Antimicrobial resistance has become one of the most substantial health issues, prompting the World Health Assembly (WHA) to urge Member States to finalise tailor made national action plans by May 2017, aligning them with objectives of the Global Action Plan (GAP). These cover awareness,... surveillance and research, hygiene infection prevention & control, optimal use of antimicrobial medicines and economic case for sustainable investment. Indonesia, by virtue of its geographical terrain and complex interactions with diverse stakeholders, indicates a higher burden of AMR. Most of the country’s data currently relies on local studies conducted by labs and universities. To get a more accurate estimate of the situation, one has to rely on results from the Regional Resistance Surveillance Programme. By undertaking such measure, Indonesia would acquire data to detect AMR trends at a national level.
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The threat posed by antimicrobial resistance (AMR) to public health as well as global health security has been reiterated in umerous World Health Assembly (WHA) resolutions. AMR is also prioritized under the Global Health Security Agenda (GHSA), and India is one of the contributing countries. The Mi...nistry of Health & Family Welfare (MoHFW) identified AMR as one of the top 10 priorities for the ministry’s collaborative work with WHO. The National Health Policy 2017 identifies antimicrobial resistance as a problem and calls for effective action to address it. An international conference on AMR – “Combating Antimicrobial Resistance: A
Public Health Challenge and Priority”, was jointly organized by the Government of India and World Health Organization (WHO) in February 2016, which was attended by more than 350 participants. The Hon’ble Prime Minister, Shri Narendra Modi, and the Hon’ble Union Minister for Health, Shri J.P. Nadda have reiterated government’s commitment to tackle AMR.
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World Health Organization, Food and Agriculture Organization of the United Nations & World Organisation for Animal Health. (2021). Antimicrobial resistance and the United Nations sustainable development cooperation framework: guidance for United Nations country teams. World Health Organization