Entrepreneurship: turning the tide against antimicrobial resistance

Entrepreneurship: turning the tide against antimicrobial resistance

Subject: Science and Tech

Section: Health

Context:

• In fight against the rising challenge of antimicrobial resistance (AMR), the search for new antibiotics is critical.
• Zosurabalpin stands out as a promising new candidate, offering a potential new way to tackle drug resistant Acinetobacter infections. Its early promise has been noted in Nature magazine and it’s now going through the first phase of clinical trials.

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• On another front, cefiderocol, already approved for use in various countries, stands out as another beacon of hope.
• Developed by the Japanese firm Shionogi and now distributed by GARDP (Global Antibiotic Research and Development Partnership), cefiderocol is making its mark as a potent agent against resistant infections.
• The Indian pharmaceutical landscape is witnessing a leap forward with Wockhardt’s cefepime­zidebactam, which is currently in international Phase 3 trials.

What is Antimicrobial Resistance (AMR)?

• Definition: Antimicrobial Resistance (AMR) occurs when bacteria, viruses, fungi, and parasites change over time and no longer respond to medicines, making infections harder to treat and increasing the risk of disease spread, severe illness, and death.
• Causes of AMR: Resistance in bacteria can arise naturally by genetic mutation or by one species acquiring resistance from another. It can also appear spontaneously because of random mutations or through the spreading of resistant genes through horizontal gene transfer.

The main causes of AMR are:

• Misuse and overuse of antimicrobials
• Lack of clean water and sanitation
• Inadequate infection prevention and control
• Lack of awareness

What are the Steps taken by the Government to address AMR?

• National Action Plan (NAP) for AMR: In April 2017, India’s NAP for AMR was released by the Union Ministry of Health and Family Welfare. The objectives of the NAP include increasing awareness, strengthening surveillance, promoting research, and improving infection prevention and control.
• Signing the Delhi Declaration on AMR: The Delhi Declaration on Antimicrobial Resistance (AMR) is an inter-ministerial consensus that was signed by the ministers of the concerned ministries in India.
• Antibiotic Stewardship Program (AMSP): The Indian Council of Medical Research (ICMR) has initiated the AMSP on a pilot project basis in 20 tertiary care hospitals across India. The program aims to control the misuse and overuse of antibiotics in hospital wards and ICUs.
• Ban on inappropriate fixed dose combinations (FDCs): On the recommendations of the ICMR, the Drug Controller General of India (DCGI) has banned 40 FDCs that were found to be inappropriate.
• Ban on the use of Colistin as a growth promoter in animal feed: The ICMR, in collaboration with the Indian Council of Agriculture Research, Department of Animal Husbandry, Dairy and Fisheries, and the DCGI, has banned the use of Colistin as a growth promoter in animal feed in poultry.
• One Health approach: The government is working on a One Health approach by encouraging interdisciplinary collaboration at the human-animal-environmental interface. The key priority areas include zoonotic diseases, food safety, and antibiotic resistance.

Integrated One Health Surveillance Network for AMR: The ICMR has undertaken a project on an “Integrated One Health Surveillance Network for Antimicrobial Resistance” in collaboration with the Indian Council of Agriculture Research to assess the preparedness of Indian Veterinary laboratories to participate in an integrated AMR surveillance network.

Schedule H1

In order to strengthen the surveillance of antimicrobial resistance (AMR) in the country, Indian Council of Medical Research (ICMR) has set up a National Anti-Microbial Resistance Research and Surveillance Network (AMRRSN) to enable compilation of national data of AMR at different levels of Health Care.

The Drugs and Cosmetic Rule, 1945 were amended in 2013 to incorporate a new Schedule H1 under the said rules containing 46 drugs which include III and IV generation antibiotics, anti TB drugs and certain habit forming drugs for having strict control over the sale of these drugs. The Drugs falling under Schedule H1 are required to be sold in the country with the following conditions:-

1. The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.
2. The drug specified in Schedule H1 shall be labeled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labeled with the following words in a box with a red border:

Further, the Government of India has formulated a National policy for containment of antimicrobial resistance in 2011. A National Programme for Containment of AMR has also been initiated in 12th Five Year Plan with the following objectives:-

• To establish a laboratory based surveillance system by strengthening laboratories for AMR in the country and to generate quality data on antimicrobial resistance for pathogens of public health importance.
• To generate awareness among healthcare providers and in the community regarding rational use of antibiotics.
• To strengthen infection control guidelines and practices and promote rational use of antibiotics.

This imitative was result of Chennai declaration on AMR