Letter to DCGI seeks emergency use nod for investigational antibiotics to save lives

Intensivists and infectious diseases specialists, faced with a dire situation where effective antibiotics to treat drug-resistant infections are lacking, have called on the government to allow emergency use authorisation (EUA), as successfully done during the COVID-19 pandemic, for certain life-saving drugs.

Intensivists and infectious diseases specialists, faced with a dire situation where effective antibiotics to treat drug-resistant infections are lacking, have called on the government to allow emergency use authorisation (EUA), as successfully done during the COVID-19 pandemic, for certain life-saving drugs.

In a letter to the Drugs Controller General of India (DCGI) Rajeev Raghuvanshi and copied to Health Minister Mansukh Mandaviya, Abdul Ghafur, Coordinator, Chennai Declaration on Anti-Microbial Resistance (AMR), has urged the government to seriously consider the matter.

“There are instances where not a single available drug in our country proves effective in treating these infections. Unfortunately, by the time we receive compassionate use permission to procure investigational antibiotics in phase 3 or licensed antibiotics from other countries, patients with severe infections succumb,” his communiqué says.

The specific plea is to allow EUA for antibiotics in phase 3 trials or licensed antibiotics from other countries. Given the gravity of using such drugs, Dr. Ghafur says, the community of infectious diseases specialists and intensivists would undertake to clear the decision to use the antibiotics by a team of doctors first.

Dr. Ghafur adds: “There are two specific antibiotics that merit EUA consideration: Cefiderocol, which has already been licensed in several countries, but not in India, and Cefepime-zidebactam, an antibiotic that is currently in phase 3 development and is being produced by an Indian company.” An appendix in the letter lists a case report showing how a patient’s life was saved using the second drug, which was procured on a compassionate-use basis with permission from the DCGI. Compassionate-use permission reportedly takes at least 48-72 hours to procure.

The letter concludes with an impassioned plea: “Our country has demonstrated remarkable progress in providing EUAs for COVID-19 vaccines, saving hundreds of thousands of lives and setting a shining example for the world. We must now extend the same level of urgency and commitment to saving the lives of patients who may otherwise succumb to infections resistant to all currently available antibiotics.”

Incidentally, the Inter-Sectoral Coordination Committee on Anti-Microbial Resistance was chaired by Union Health secretary Rajesh Bhushan, in Delhi on Thursday. Mr. Bhushan highlighted the need for joint efforts of all stakeholders through a unified mission mode approach.