10 May 2021 12:02 am Views - 25628
Days after the Dhammika Paniya was rejected as a cure for Covid -19, another so-called ‘miraculous’ medical discovery does its rounds on social media. however, authorities question the claims
Even if it is an Ayurvedic product a lot of research has to be done. None of the facilities at Karapitiya Hospital was used in the development of this product
Days after the Dhammika Paniya was rejected as a cure against COVID-19, news about another so-called ‘miraculous’ medical discovery against COVID-19 did its rounds on
A promotional leaflet describes this product as “the ONLY product in the world (backed by science) that can be given to COVID-19 positive patients.” However, the Karapitiya Teaching Hospital denied any connection to the development of this product while the University of Ruhuna also issued a detailed statement also denying any connection to the product while stating that there is no regulatory body for approval situated at the Faculty of Medicine, University of Ruhuna.
About MeGha Primal Intake
The so-called product launch was held in March as seen in a video uploaded on social media. A video of several people who had received the tablet shared their experiences as well. They speak about the miraculous healing power of this tablet while recommending it for consumption. Speaking at the launch, Dr Nanda Gunawardhana, Director of International Relations and Research at Sri Lanka Technological Campus highlights the health benefits of the product and why it needs to be marketed. He also gives an overview of the healing power of local herbs and how alkaloids that were used to produce the tablet can boost the immune system. Speaking about its scientific benefits, Dr Udara Sampath Gunawardhana, the younger brother of Dr Nanda Gunawardhana attached to the Karapitiya Teaching Hospital said that the product was designed to be sent to the international market.
“We never thought this had to be given to Sri Lankans. The research for this product was based on the Cytokine Storm observed in COVID-19 patients who are critical and are in ICU care.
"When medicine is being developed, it has to go through an ethics review committee and it has to be registered for clinical testing. Approvals have to be obtained from various authorities"
“The severity of COVID-19 is associated with an increased level of inflammatory mediators, the Cytokine Storm is most likely induced by interleukin-6 (IL-6) amplifier. There are two types of alveolar cells in the lungs and COVID-19 attacks Type 2.
“Surfactant, a surface-active lipoprotein complex formed by these Type I alveolar cells keeps lungs open. But when the virus damages these cells, it hinders the production of surfactant and the lungs shrink in.”
“The tablet was given to the Ministry of Health, several senior professors and it has not been challenged so far. We plan to improve it further and send it to the foreign market.”
"The Faculty of Medicine, University of Ruhuna does not have the technical capability to recommend the use of this product against COVID-19. Therefore, Faculty of Medicine, University of Ruhuna wishes to dissociate from the said person and the discovery,” the statement read"
Only a food supplement
Responding to queries posed by journalists at the launch he said that the tablet was actually a “food supplement” produced according to the guidelines laid out by the Sri Lankan Food Act.
“Since it is a food supplement, approval from National Medicines Regulatory Authority isn’t required but it was presented to the Ministry of Health – Food Safety Unit. If it is to be developed as a medicine clinical trials need to be conducted.
“Clinical trials would take around two years to complete and it would take around one and a half months to get clearance from the ethics review committee. Therefore we decided to introduce it as a food supplement.”
The doctors however didn’t give a clear answer when a journalist asked if the Consumer Affairs Authority (CAA) was informed about this product.
No permission sought
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Dr Nanda Gunawardhana |
“None of the authorities have been informed about this product,” Karapitiya Teaching Hospital Director Dr Priyantha Jeevaratne claimed.
“The hospital name has been used without permission and we have informed the Director-General of Health Services as well. When developing a medicine proper approvals and methodologies need to be followed. Even if it is an Ayurvedic product a lot of research has to be done. None of the facilities at Karapitiya Hospital was used in the development of this product.”
Bogus products to gain monetary benefits
“There are many bogus products that are being produced by doctors to gain monetary benefits in the wake of COVID-19,” opined Prof. Sisira Siribaddana, Consultant Physician and Professor of Medicine at the University of Rajarata.
“I don’t think NMRA approval has been sought either. These products aren’t clinically tested and there’s no scientific basis. Certain doctors play on the anxiety of people. The only product we tested was the Dhammika Paniya.”
He said that if it were Western medicine it had to be tested according to methodologies developed by Western Medical Science.
“When medicine is being developed, it has to go through an ethics review committee and it has to be registered for clinical testing. Approvals have to be obtained from various authorities. If these processes are not followed it should not be used.”
The University of Ruhuna requests the public not to get misled
In a statement issued by the Vice-Chancellor of the University of Ruhuna, the public has been requested to refrain from inquiring about this drug or nutrition supplement while stating the University has no involvement in the development of the product.
“The Faculty of Medicine, University of Ruhuna has been getting numerous calls inquiring after the food supplement/medicinal preparation/drug/capsule prepared by Dr Udara Sampath Gunawardhana and his team claimed to be effective against COVID-19. The Faculty of Medicine, University of Ruhuna has nothing to do with this development or discovery. However, the Faculty of Medicine, University of Ruhuna admits that Dr Udara Sampath Gunawardena is an alumnus of the University being a graduate of the Faculty of Medicine.”
“We also wish to state that the curriculum of the Faculty of Medicine is teaching Allopathic (Western Medicine) and not indigenous medicine. Therefore, we are certain that Dr Udara Sampath Gunawardhana was never taught any indigenous medicine while in the Faculty of Medicine, University of Ruhuna.
“However, the Faculty of Medicine, University of clearly teaches its undergraduates on clinical trials, research and research methodologies, drug discovery and registration, ethics and moral values in patient care and research to the extent required to be a good doctor. Therefore Dr Udara Sampath Gunawardena has a moral obligation to show research evidence for his claim.”
"Since it is a food supplement, approval from National Medicines Regulatory Authority isn’t required but it was presented to the Ministry of Health – Food Safety Unit. If it is to be developed as a medicine clinical trials need to be conducted - Dr. Udara Gunawardhana"
“Since there is the apparent claim that this product has received approval from regulatory authorities, I do hereby inform the public that there is NO such regulatory body for approval situated at the Faculty of Medicine, the University of Ruhuna which is located at Karapitiya.
“Specifically, the Department of Pharmacology of the Faculty of Medicine, Ethics Review Committee of the Faculty of Medicine or the Department of Pharmacy of the Faculty of Allied Health Sciences of the University of Ruhuna do NOT have any connection with the product development, research, request for approval or approving. No staff member was ever involved in this drug development activity. The Faculty of Medicine, University of Ruhuna does not have the technical capability to recommend the use of this product against COVID-19. Therefore, Faculty of Medicine, University of Ruhuna wishes to dissociate from the said person and the discovery,” the statement read.
Will respond to allegations soon
In response to mounting allegations, a video of Dr Udara Sampath Gunawardhana has been uploaded to the MeGha Facebook page where he claims that a lot of allegations and misinformation regarding the product is being circulated.
“Our objective is to reduce the number of deaths related to COVID-19. There is nothing illegal in what we are doing. I hope to respond to each and every allegation targeted at this product shortly.”
The Daily Mirror tried contacting both the doctors on numerous occasions but could reach only a spokesperson who told that both the doctors were extremely held up with work.