Context
- India is set to introduce two new, powerful antibiotics:
- Cefiderocol
- Cefepime-zidebactam
- Concerns raised over misuse and irrational prescription of such last-line antibiotics without regulatory safeguards.
Relevance : GS 2(Health ) ,GS 3(Research)
Key Concern
- Ceftazidime-avibactam, already in the Indian market since 2018, is:
- A last-line antibiotic meant for carbapenem–resistant gram-negative infections.
- Now losing efficacy due to overuse and misuse, even in community settings.
- Aztreonam is often combined with it to overcome resistance — but now even this combination is facing resistance.
Gaps in Regulation
- The DCGI has:
- Licensed the drug.
- Provided indications for its use.
- However:
- No strict regulatory pathway exists.
- No enforcement against mis-prescription.
- No antibiotic stewardship framework mandated.
Expert Appeal
- Dr. Abdul Ghafur, AMR Declaration Trust, has:
- Written to the DCGI urging strict control mechanisms.
- Warned that education alone is insufficient — regulatory action is essential.
- Called for use only where no other alternatives exist.
AMR Threat
- Antimicrobial Resistance (AMR):
- Already a critical health threat in India.
- Past gains (e.g., ban on colistin in poultry) risk being nullified by uncontrolled antibiotic use.
- India risks losing last-line treatments if AMR continues unchecked.
Proposed Action Points
- DCGI should:
- Establish clear prescription protocols.
- Monitor and restrict availability to specific hospital settings.
- Integrate these drugs into a national antimicrobial stewardship program.
- Mandate prescription audits and penalties for misuse.
