India’s ICMR Excludes Ivermectin from National Guidelines for COVID-19: Not Sufficient Evidence via RCTs

Oct 23, 2020 | COVID-19, Ivermectin, National Guidelines, News, Popular Posts

India’s ICMR Excludes Ivermectin from National Guidelines for COVID-19 Not Sufficient Evidence via RCTs

Although some Indian states such as Uttar Pradesh allow for the use of Ivermectin off label as a treatment option as well as a prophylaxis for COVID-19, sources recently shared with Indian media that the Indian Council of Medical Research (ICMR)’s National Task Force for COVID-19 and the Joint Monitoring Group recently held a meeting to determine if the drug would be included in the Health Ministry’s Clinical Management Protocol for COVID-19—it will not.

Relatively Safe & Approved Drug

Ivermectin is approved by Indian authorities for indication against parasites, such as scabies and intestinal parasites (as is the case in the United States). The relatively safe and cheap drug has been embraced in many nations as a treatment for COVID-19. Interest started after a Monash University (Australia) lab demonstrated in vitro that Ivermectin zaps the SARS-CoV-2 within 48 hours. After a number of case series efforts in various primarily developing nations occurred, from Bangladesh to Peru and even the United States. TrialSite has been at the forefront reporting on these unfolding hospital protocols, observational studies and even a couple randomized controlled trials. Search Trialsite for a number of studies.

Lack of Evidence

TrialSite has chronicled extensive use in select Indian states however the Health Ministry source recently shared in the Hindustan Times reported, “Following deliberations, experts decided not to include Ivermectin in the national clinical management protocol for COVID-19 because of lack of sufficient evidence on its efficacy based on randomized trials held in India and abroad.” TrialSite has chronicled a number of important observational studies (e.g. ICON) involving Ivermectin in addition to at least two randomized controlled studies, one in Middle East. The general tendency however among national regulatory and research authorities is to demand for more extensive, more comprehensive randomized controlled trials.

What are They Including?

However, the local media reminded readers that Remdesivir is allowed by the Health Ministry for restricted emergency use purposes in moderate cases under investigational therapies in the nation’s Clinical Management Protocol for COVID-19.

Note, the ministry has also given the thumbs up for Tocilizumab even through the randomized controlled trials demonstrate no efficacy. In fact, TrialSite just reported that the U.S. is not including this IL-6 inhibitor in its national guidelines for that very reasons.

India is accepting Hydroxychloroquine for early course disease treatment but not for critically ill patients. They are accepting Dexamethasone for those COVID-19 patients in the moderate to severe stage which differs than America, which follows the RECOVERY trial recommendation (only in mode severe cases where hospitalized patients also need breathing assistance via ventilator or other mechanical support).

Note nothing was mentioned about Favipiravir which is now approved in India, at least on a provisional basis during the COVID-19 pandemic, as evidenced by several generic versions of the drug for COVID-19.

Indian Council of Medical Research

The Indian Council of Medical Research, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest and largest medical research bodies in the world.

The Source: This information was recently reported recently in Hindustan Times, an Indian English-language daily newspaper introduced by Mahatma Gandhi in 1924. This news source played integral roles in the Indian independence movement as a nationalist and pro-Congress daily. Now this media is owned by Shobhana Bhartia and is a flagship publication of HT Media, an entity owned by KK Birla family.

5 Comments

  1. David Jans

    Obviously one can only be surprised at the ICMR decision. There is no RCT evidence supporting the idea that Remdesivir is worth persisting with (expensive, intravenous, and no clinical benefit beyond a perceived day or two less in hospital [if you are going to recover]), and yet several preliminary results from RCTs and observational studies clearly indicate efficacy for ivermectin as treatment and prophylactic. We tried to summarise this in a recent review (link below) listing all the trials, publications on trials, and preliminary data where available. I wonder what “evidence” the ICMR wants ?
    DAJ

    https://doi.org/10.1016/j.bbrc.2020.10.042

    • TrialSite

      Dear David,
      We have followed a couple randomized controlled studies and several observational studies, including one here in the States that evidences efficacy and safety. We are seeing the same trend around the world. For example in nations where ivermectin is allowed as an off label treatment covid at the local level the national authorities and research bodies are not touching this subject.
      Regards,
      Publisher

    • alan cannell

      David

      Great stuff!
      Add the Federal University Hospital of Sergipe (Brazil) trial of nano delivery of IVM
      details alcannellatgmail.com

    • Dr. Dhananjay Bakhle

      Dear David,

      Read your original article. My question is whether virus needs to get into the nucleus to produce damage and if the EC50 has to be crossed in the serum concentration of Ivermectin to produce these effects. If so, does the pk allow such concentrations to reach after 12 mg dose?

  2. Dieck

    It’s so much easier to watch people die than to fight with the FDA. FDA has their fingerprints on everything that goes on around the world. Follow the money. Who pays the bills for the FDA. Everything that happens, if it is to have a lasting effect, needs the stamp of approval of the FDA, no matter who or where it happens. The ICMR needs to do their homework.