The proposed roadmap for phage therapy to be considered as one of the solutions to AMR:
1. Having access and consolidation of comprehensive statistics on AMR in the country.
2. Building a network of phage researchers to understand their area of research.
3. Collaborative interface between phage researchers and the clinical scientists
4. Hospitals maintaining a stock of clinical strains resistant to antibiotics/contribute to repositories being (proposed to) maintained by national institutes.
5. Isolation and amplification of purified lytic bacteriophage against the clinical isolates, following standard operating protocols to ensure clean preparation. Additional laboratory space in hospitals and/or separate centres for building repositories/‘Well Characterized Phage Centres’ of lytic phages on a continuous basis.
6. Storage and maintenance of phages suitable for ensuring viability of phages.
7. Investing in R&D for additional characterization of phages to be used as therapeutics.
8. Research on purification and characterization of endolysins (Lytic enzymes) as drug candidates.
9. Pre-clinical and clinical trials to evaluate the safety and effectiveness of phages, to be corroborated by regulatory agencies. Understanding the pharmacological considerations such as dose and formulation requirement for an efficacious treatment.
10. Cases where clinical trials are not an option and the patient is found not to respond to available drugs, approval of compassionate use of bacteriophages as emergency investigative drugs (eID) for treating drug-resistant infections.
11. Phage therapy for topical applications on wounds and for skin/eye/ear infections to be expedited.
12. Chalk out key criteria and regulatory framework specific to bacteriophages and the derived enzymes to be used as therapeutics and navigate the legal issues pertaining to intellectual property in a timely manner.
13. Drafting of regulatory policies to enable use of phages in animal feed, poultry, aquaculture and in the veterinary field.
