NEW DELHI: The Indian Council of Medical Research (ICMR) on Thursday announced a new therapy for Covid-19 treatment even though it has not undergone any safety or efficacy trials yet.
In a series of tweets, the health research body announced that it had, along with Hyderabad-based Biological E Limited, had developed highly-purified 'Antisera', raised in horses, for prophylaxis and treatment of Covid-19.
It added that such measures have previously been used to control many viral and bacterial infections.
“Although the plasma, recovered from patients experiencing Covid-19, could serve a similar purpose, the profile of antibodies, their efficacy, and concentration keep varying from one patient to another and therefore make it an unreliable clinical tool for patient management,” the research body said.
“Standardization achievable through equine sera-based treatment modality thus stands out as yet another remarkable public health initiative supported by ICMR in the time of Covid-19”.
Speaking with this newspaper, Dr. Samiran Panda, the chief scientist with the ICMR, said that it was a “great product based on neutralising antibodies raised in horses which were given antigens and is set to be launched now”.
“We have approached the drug regulator for permission to allow the product as an investigational therapy in the country and it will come through soon,” he said.
On being asked whether the safety and efficacy trials had been conducted to assess that the antisera work in the case of Covid-19, he said that trial may or may not take place.
“We now have the product which is based on an old medical science concept and we are sure people will benefit from it,” he said.
Experts, meanwhile, said that while the method for developing antisera itself is not new, the approach of the highest medical research body in the country in pushing the therapy is questionable.
“The philosophy behind the therapy is now new and is used in many conditions such as snake bite, diphtheria, and rabies among others but such antibodies cannot be given to patients or people without trying it out in actual scientific trials,” stressed Dr. S P Kalantri, researcher and medical superintendent of the MGIMS in Wardha.
He added that it was unethical and unscientific on the part of the ICMR to violate its own principles of scientific research.
“I am also surprised that on what basis is ICMR recommending it for both prevention and treatment of the disease? Where is the evidence to suggest that it is effective and safe in both scenarios?” he asked.
Virologist Dr. Shahid Jameel too, citing the WHO guidelines on anti-venoms said that proper preclinical and clinical assessment is recommended for antiserum.
“Even if it’s not a randomised control trial, proper safety and efficacy have to be established before recommending it for patients,” he said.