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Ivermectin divides doctors while NMRA gives waiver to import drug to stop black market sales
The medical fraternity is heavily divided over the use of Ivermectin in COVID-19 treatment and prevention, with many arguments for and against on social media.
Ivermectin, which comes in tablet form, is a medication for the treatment of parasite infestations.
A high-level group of experts has reiterated that there is “insufficient evidence” to recommend for or against the use of Ivermectin, Hydroxychloroquine (HCQ), Vitamin D, Zinc and Vitamin C for COVID-19 patients in a clinical guideline at present.
Some senior clinicians are clamouring for Ivermectin in the treatment or as a prophylaxis (prevention of disease) against COVID-19, while other experts who study scientific evidence refute such claims.
Sources said the National Medicines Regulatory Authority (NMRA) had given a waiver of registration to import Ivermectin to prevent thriving black market sales.
“Unscrupulous people are selling Ivermectin at exorbitant rates and fleecing the public,” a source said.
While assuring that it will review emerging evidence regularly and revise its recommendations accordingly, the ‘Expert Committee appointed to prevent COVID-19 mortality’ says that it met several times to discuss Ivermectin and other pharmaceutical products as treatment or prophylaxis for COVID-19.
After deliberations with local and foreign experts on this subject, the committee was “unanimously” of the opinion that there is insufficient evidence to recommend for or against their use.
“If any clinician is using Ivermectin, it is strongly suggested to document the indication, disease status, side-effects, outcomes and any other relevant details for each patient,” it states.
Comprising Dr. Ananda Wijewickrama, Dr. Indika Lanerole, Prof. Chandani Wanigatunge, Dr. Bandu Gunasena, Dr. Harsha Sathischandra, Dr. Mahendra Ekanayake, Dr. Anoma Perera, Dr. Ajith Tennakoon, Dr. Shirani Chandrasiri, Dr. Malika Karunaratne, Dr. Channa Perera, Dr. Hasitha Tissera, Dr. Upul Dissanayake and Dr. Azar Ghouse, the committee has informed the Director-General of Health Services of its stance on August 20.
Meanwhile, in August, the NMRA granted ‘Approval for waiver of pharmaceuticals registration’ to Ivermectin.
NMRA’s Chief Executive Officer Dr. Kamal Jayasinghe said that several local agents including George Steuart Health (Pvt) Ltd., ABC Pharma and Emerchemie have been granted this ‘approval of waiver’ to bring in Ivermectin.
When asked for what purpose Ivermectin would be prescribed, NMRA Chairperson Dr. Rasitha Wijewantha told the Sunday Times that it would have to be decided by clinicians after studying scientific evidence.
He said that a waiver of registration (WOR) was granted because there are many drugs including Ivermectin which fall under the category for which no agent usually seeks registration. This is because they are not popular drugs and have a small market share.
“We are in the process of taking a policy decision to encourage registration and import of such drugs by giving small incentives such as reducing the registration fee,” he said.
Usually, Ivermectin tablets are used in the treatment of parasitic roundworm infections (like intestinal strongyloidiasis) and river blindness (onchocerciasis caused by the blackfly). Topical forms (which are applied to body surfaces) are used in the treatment of external parasites (head lice and skin conditions such as rosacea).
Some forms of animal Ivermectin, meanwhile, prevent heartworm disease and treat certain internal/external parasites but are not for humans.