The Medicines Control Authority of Zimbabwe (MCAZ) is yet to receive Aguma for registration amid indications that the process could take longer than expected, HealthTimes can reveal.
By Kudakwashe Pembere
It has been over two weeks since his ‘HIV Cure’ proclamation by Prophetic Healing and Deliverance Ministries frontman Prophet Magaya which left many Zimbabweans, the World Health Organisation, local medical related groups, and even foreign experts shocked disproving the claims.
Information gathered by HealthTimes show that the medication has not seen the doors of MCAZ.
“There have been some engagements between Prophet Magaya and Ministry of Health and Child Care, however MCAZ is yet to receive the application for registration of the product in question,” said the authority’s spokesperson Mr Shingai Gwatidzo responding to questions sent by this publication.
Mr Gwatidzo explained that the medicine registration procedures are rigorous.
“The process of registration of medicines is rather comprehensive and thorough, involving submission of technical information (dossier) detailing development, production, clinical trials and safety data, stability studies, bioequivalence/bioavailability studies to mention but these.
“Further information on requirements for safe and ethical conduct of clinical trials involving humans can also be obtained from Medical Research Council of Zimbabwe,” he said.
Quality control samples from MRCZ are to be submitted.
“This is followed by submission of samples for quality control testing to ensure quality and safety requirements are met,” said Mr Gwatidzo.
Mr Gwatidzo also noted, “There is also a component of inspection of the manufacturing process whereby officers from MCAZ must visit the plant where the manufacturing is taking place. A product can only be considered safe, effective and of good quality after satisfying these minimum requirements (Note well that this list is not exhaustive).”
MRCZ could not disclose whether or not Aguma was submitted to them for clinical trials.
“We value the privacy of our students or any person who submits their proposals for testing so I cannot disclose anything. At the moment, I’m not saying we received or we didn’t but I cant disclose anything from the students or researchers,” said a council secretariat member who requested anonymity.
MRCZ is a specialized Council of the Research Council of Zimbabwe to provide health researchers and institutions which/in which health research is conducted, with independent ethical oversight on research conducted by those researchers or by / within those institutions. The MRCZ is established and supported by the Government of Zimbabwe through the Ministry of Health and Child Welfare. It is composed of scientists, medical experts, ethicists, lawyer, and religious community representatives. It is independent in its reflection, advice and decision.
Efforts to get comment from Aretha Medicals which manufactured Aguma were fruitless.
Last week, the cleric promised to take the ‘immune booster’ for trials at a joint Press conference with the Ministry of Health and Childcare and PHD Ministries.
“According to what the Ministry has assured us, we are going to run very intense trials until they have come up with a position on the plant,” said Prophet Magaya.
Minister Obadiah Moyo revealed that Prophet Magaya assured Government that he will not dispense any of his products.
With the clinical trials in waiting, Dr Moyo said the process will start with Prophet Magaya availing his documentation of efficacy trials he said were conducted in India.
“Prophet Magaya’s medicines are not yet approved. Yes he has got the claim of the research which was carried in India. But this was in India and not Zimbabwe.
Prophet Magaya said he would bankroll the clinical trials.
He said they would ensure transparency.
“Prophet Magaya’s people will be part of the team. Everyone will be checking each other so that we do not come out with any falsification of results. We are an authority, a ministry, we are genuine and will make sure that whatever we do will be in line with laid-down laws.
“We will ensure the ministry and himself will carry out this clinical trial,” explained Dr Moyo.