THERE was panic and finger pointing during a Parliamentary Public Accounts Committee (PAC) hearing of the Ministry of Health drug supply scandal yesterday as government officials and directors of Honeybee Pharmacy sweated to explain how a US$17 million contract was awarded to an unregistered company which delivered toxic drugs and substandard condoms.
And Ministry of Health Permanent Secretary Kakulubelwa Mulalelo has been stripped off the role of controlling officer at the Ministry of Health, and remains on suspension.
Mulalelo who is PS in charge of administration was suspended from work over a week ago and came from home when she appeared before the Parliamentary Accounts Committee and the controlling officer role has been assigned to Dr Kennedy Malama.
Leading the delegation of government officials which appeared before PAC yesterday, Mulalelo expressed ignorance about how most pertinent decisions came to be, asking heads of other institutions like the Zambia Medicines Regulatory Authority [ZAMRA], Medical Stores Limited (MSL) and Zambia Bureau of Standards (ZABS), as well as Honeybee to respond to queries instead.
During the sitting, Wednesday, MSL managing director Chikuta Mbewe admitted that Honeybee supplied substandard condoms and gloves were distributed in September 2020, without conducting any quality assurance tests.
Mbewe also admitted that the said condoms and gloves were not safe for human consumption given that they failed quality tests at ZABS, further telling the committee that these items were still in circulation.
When asked why the condoms and gloves were not recalled despite failing tests at ZABS, ZAMRA director laboratory services Bonaventure Chilindi said his institution was still waiting to receive ‘confirmation’ test results from a laboratory in Zimbabwe.
Meanwhile, Milenge PF member of parliament Mwansa Mbulakulima said what the Ministry of Health was doing amounted to genocide.
Below is a verbatim of the PAC sitting:
Mulalelo (Submission): …Thank you Honorable Chairperson and good morning once more. I will continue from where I left off [on Tuesday]. So we continue with page 20 of our submission.
The first item that was observed is failure to observe quality control test certificates. The observation was that the special conditions of the contract clause under delivery and documents required among others that the original certificate of quality control tests results are in conformity with the WHO certification scheme on the quality of pharmaceutical products moving in international trade be availed to the procuring entity.
A review of the letter of goods acceptance certificate by Medical Stores Limited revealed that the health centre kits were not accompanied by the certificate of analysis from the manufacturer/supplier. In this regard, tests were carried out by ZAMRA and Zambia Bureau of Standards to assess the quality of the medicines and medical supplies and the results were as follows: the first one was on the test of paracetamol tablets. ZAMRA undertook tests on the paracetamol tablets, that’s BP 100mg and BP 500mg contained in the health centre kits that had been supplied and had an invoice value of US$179,074.37.
A review of the certificates of analysis dated 10th September, 2020 on paracetamol tablets BP 500mg revealed that the tablets had mould like growth on the surfaces and that the sample did not meet acceptance criteria for appearance test and the pictures are contained in our submission. In addition, a review of certificate of analysis dated 16th September, 2020 on paracetamol BP 100mg revealed that the sample did not meet the acceptable criteria for assay and friability tests.
Honorable Chairperson, we wish to submit our response to this observation as follows:
Chairperson, the observations made by the auditors are noted, the Ministry of Health, through ZAMRA is mandated to carry out investigations on medicines beyond the physical inspection which primarily is conducted by Medical Stores Limited on receipt of medical products. While certificates of analysis are used preliminarily to ascertain the quality, initial quality assurance tests are done on sampled products and items distributed to facilities.
ZAMRA with its intelligence in the department of medicines control who are now dotted in strategic regions across the country continue with periodic sampling of commodities to ascertain the quality as part of post marketing surveillance. This is also complemented by the strong pharmacovigilant system in health facilities which allows all our health workers including clients to report to ZAMRA, which anchors this program. Any medicine related problems for appropriate investigations and action hence the quarantine and recourse that are normally reported in order to protect the general public, not only locally but globally.
The cited paracetamol was cited by the Ministry of Health’s active pharmacovigilance activities prevalent at health facility level. The Ministry of Health through ZAMRA has instituted a recall of all batches of paracetamol tablets that were distributed. See attached letter from ZAMRA dated 9th and 17th September, 2020 respectively. The supplier, in a letter dated 15th September, 2020 has confirmed having engaged the manufacturer to replace all recalled batches, the manufacturer in response has availed documentary evidence that he has commenced manufacture to replace the products and the same shall be done in blister packaging of 100 strips by 10 tablets packed in mono carton. This is so as to reduce the risk of the product being affected by moisture. Honorable Chairperson, I wish to submit additional information since this submission was done a month ago that the paracetamol that the supplier said that he would replace, that was recalled, has since been replaced and we have the delivery note that shows that all the paracetamol has been replaced and delivered to Medical Stores. Honorable Chairperson, the letter from the supplier indicating the replacement of the batches is attached under appendix 13.
The next observation is on the lubricated latex condoms. A laboratory test report dated 22nd September, 2020 from Zambia Bureau of Standards revealed that the condoms supplied with the invoice value of US$114,428.16 had failed on the following parameters: the first one was bursting volume, second, hang and roll that’s water tightness, length and package integrity. Our response Honorable Chairperson, management noted the auditor’s observations. The Ministry of Health, through ZAMRA is mandated to carry out investigations on medicines and associated commodities, in so doing, samples of this product were sent for testing in Zimbabwe at a WHO accredited laboratory. This is in accordance with the standard operating procedures for post marketing surveillance. Results are still being awaited from the laboratory.
The next observation is on the latex examination gloves. The observation states, a laboratory test dated 22nd September, 2020 from Zambia Bureau of Standards revealed that the latex examination gloves supplied with an invoice value of US$109,961.28 had failed the water tightness test. Honorable Chairperson, our response, having served the observations by the auditors, the Ministry of Health through ZAMRA is mandated to carry out investigations on medicines and associated commodities, in so doing, samples of this product were also sent to Zimbabwe at a WHO accredited laboratory. This is in accordance with the standard operating procedures for post marketing surveillance. The results are still being awaited.
Other observations, there was an observation on the soap bar that was supplied in the kits with an invoice value of US$8,068 that did not have a trade and manufacturer’s name. Another observation on the diazepam injection with an invoice value of US$4,656.96 which was missing from the health center kits and the third observation was the four grams of tetracycline and one percent HCL eye ointment tube that was supplied instead of the five grams which had an invoice value of US$22,952.16.
Honorable Chairperson, the Ministry of Health, through Medical Stores as part of the physical inspection of the products made similar observations as those stated in the audit report. A discrepancy report was issued to the supplier as part of the delivery notes and documentation that was issued. The following are the comments and actions that have been taken in this regard. On the soap bar, the observation that the soap bar supplied in the kit had no manufacturer’s name including the trade name of the soap bar supplied is well noted.
This is one of the products being pursued for further analysis, management wishes to indicate that ZAMRA and other relevant regulatory institutions will continue to carry out various analytical tests on all products because results do not come at the same time depending on the nature of the product and availability of equipment and reagents. For the diazepam, the findings that diazepam was missing in the kit is noted.
This is a product, Honorable Chairperson, which is now highly controlled due to the potential to be abused by clients. The processes to acquire this product is different from the rest of the products in the kit and therefore the supplier did inform the ministry that the product would be supplied separately. The value of the diazepam was not included in the value of the goods that were supplied. You may wish to note that this information is contained in the goods acceptance certificate as issued by Medical Stores Limited as attached under appendix 14.
Honorable Chairperson, I wish to submit additional information on the diazepam, we have since received the diazepam. Since the supplier did indicate that this would be supplied separately and it has been receipted. On their third observation, this is tetracycline, the findings that the contract provided for tetracycline 5g HCL one percent eye ointment tube but four grams was delivered has been noted.
This is an anomaly that requires the supplier to reduce the price or increase the quantity of the products. It must be noted, Honorable Chairperson, that the supplier did in fact supply more of this product in order to compensate for the reduced grams. The documentation is attached under appendix 15 and it shows that in the kit there was supposed to be 15 tubes and the supplier did submit 19 tubes of the tetracycline.
(End of submission)
Q & A session
PAC chairperson Howard Kunda: Before Honourable [Chavuma UPND member of parliament Victor] Lumayi comes in, there were two questions that were posed by Honorable Mbulakulima and he had requested that those questions be answered and also said that we should have those answers provided at the beginning of our questioning. So, if you can go ahead and just answer those questions that were posed by Honorable Mbulakulima.
PS: Honourable chairperson, if I could ask the honourable member of parliament for Milenge to kindly repeat his questions. I may not have picked them well because there was breakage in transmission yesterday.
Kunda: Honourable Mbulakulima, the questions that you had posed, if you can just repeat so that PS can be able to answer.
Mbulakulima: My two questions were very simple. We are doing so much with emergency, emergency and emergency and that is why we got those deliveries. I wanted her (PS) to tell me whether now she realizes that what she considered as an emergency actually turned out to be the worst problem worsening the situation? So, is that the way we handle the emergency?
Secondly, in their submissions, the three bidders did not meet the criteria and they treated this as a minor deviation. Don’t you think that this is what led to the total breakdown or failure?
Kunda: Yes PS, if you can address those two concerns.
PS: Thank you Honourable chairperson. The first question was on the issue of the emergency and the delivery periods. Honourable chairperson, I believe I did respond to this question yesterday having stated that there were challenges that the supplier had which he communicated to us in terms of him being able to deliver within time. These are challenges beyond the supplier and that some of them were global challenges with regard to logistics. The supplier had a challenge because there was a lockdown [and] as such, he was unable to avail the drugs within the period which was stipulated in the contract.
Honourable chairperson, we all know the challenges which COVID-19 posed in 2020 and the supplier did make that information available to us. So, I submit with regard to the issue of emergency.
In terms of meeting the criteria, Honourable chairperson, I did submit the position under the various criteria with which the evaluation committee made their recommendations, and these recommendations formed the basis upon which each supplier was recommended for award of contracts, without the award of contracts, Honourable chairperson, we may not have had drugs within our facilities last year. I submit.
Kunda: Now PS, you are stating that the supply of these medicines were affected by COVID-19 and in your reference you are saying 2020. The issues that we went through as a result we had these items of medicines not supplied. Now, the duration or the timeframe that was given for the contract or to the contractor or to the supplier to supply this is 8 to 12 weeks. And if I remember very well is that this contract was signed and given in November which was spilling over to 2020.
But looking at the time that this COVID-19 was announced was in December, how then are we referring to it when the supply period was 8 to 12 weeks? And now, we are talking about 2020.
Mbulakulima: The COVID-19 started in March.
Kunda: So, why are we referring to it when we had enough time?
Lumayi: Director Honeybee, as you can see the committee is seated here, the whole issue is surrounding sourcing of medicines and medical supplies from unapproved manufacturers and also questionable supply of unregistered medicines through ZAMRA. Director, the bid to invite bidders to apply for the supply of these medicines was done on 3rd September, 2019 and your company had only been registered on 28th August, 2019. That was six days before the bids were invited and this was done through a limited bid. And you became amongst the 10 bidders.
So, one, you need to help this committee to understand how you found yourself with the evaluation committee? And then you submitted to the evaluation committee of the Ministry of Health, the recommendation letters about Honeybee. I have told you that your company was registered on 28th August, 2019. One of your recommendation letters came from ADRA and there is no address of ADRA but it reads ‘ADRA, the Adventist Development and Relief Agency-Malawi. This is to put on record that Honeybee Pharmacy of Plot No.25232, off Mwembeshi road, Chinika Industrial area, Lusaka Zambia supplied us with 16, 000 units of health care kits after successfully winning a tender floated by us in 2016.’ And in this recommendation letter, there is no address of the people who recommended you to our Ministry of Health.
And also we have another letter from the Ministry of Health recommending Honeybee which is coming from Gauteng Province in the Republic of South Africa. And also there is no traceable addressee on the recommendations. So, I want you to help the committee to understand how you became part of this and also what made you bring medicines in the Republic of Zambia which were coming from unapproved manufacturers? Chair, I want the director to help this committee to understand so that this issue surrounding Honeybee is cleared.
Kunda: Yes PS, this issue it’s you to give authority.
PS: Honourable chairperson apologies but I believe the honourable member was directing this question to Honeybee but…
Kunda: Yes, but you are the principal and I am asking you. So, if you could state something or give her a chance to respond.
PS: The question was directed to Honeybee and so I will ask Honeybee to respond.
Kunda: Let us be together. Yes, director from Honeybee. If you can just state your name and please switch on the microphone as you speak.
Abdulahim Motala [joined in via Zoom]: My name is Imran…, I am one of the directors from Honeybee.
Kunda: Yes but I have not given you a chance to speak. So you need to request for it. I have given a chance to the person who is here in this room representing Honeybee. And now that we have also seen that you are also from Honeybee, if you can introduce yourself so that we know you then at a letter stage, we will give you a chance also to speak if you have to. You can introduce yourself so that we know you.
Abdulahim: Thank you so much chair. My name is Abdulahim Motala and I am one of the directors of Honeybee. Thank you.
Kunda [turns to second Honeybee representative]: Please introduce yourself again so that we know because now we have two people representing Honeybee.
Zakiir Motala: Thank you chair, my name is Zakir Motala, director of Honeybee Pharmacy.
Kunda: Okay, so, you are also one of the directors?
Zackiir: Yes, one of the directors.
Kunda: You can go ahead and deal with those issues that have been highlighted by the honorable member.
Zackiir: Yes honourable chair. Honeybee Pharmacy Limited has a very unique system of operating. We have got agents across many countries that act on our behalf, hence our supplies in South Africa and Malawi. We have got agents across Tanzania, Mozambique and India. And with regards to the headed paper that the honorable member has asked, we requested for these documents from our agents because we have supplied in South Africa and Malawi through the same agents. So, we requested for these documents and these are the documents that were made available to us.
If more information was needed for the ministry, we would definitely have reverted back to our agents to help us with more information. Unfortunately [for] the bidding document, the information that was requested from us was not very to the point.
Kunda: And on the issue of registration before you got the contract? Maybe if you can also just drop the mask so that we can get you clearly.
And let me also mention that you know, we requested that you come and appear before this committee because there are a number of issues that we need clarity on surrounding Honeybee because it was reported in the Auditor General’s report that there were some irregularities so that is why we are asking these questions. So be free and that you are protected under the laws of Zambia, in particular Cap 12 of the laws of Zambia provides for immunity so whatever you say here will not be used against you but of course if you decide to mislead the committee, the same provision it goes against you so just be free and give us the correct information. You can go ahead.
Zakiir: We were talking about the letters of experience and these letters of experience I was explaining that at Honeybee Pharmacy, we have a unique system of operations, we have agents across many countries that act on our behalf and these are the agents that we use to supply in South Africa and Malawi. When this bid document, when there was this requirement, we engaged the agents to give us proof, to furnish us proof of what we supplied in South Africa and in Malawi and these are the documents that we submitted in the bid. I would also like to add that if additional information was needed from the ministry, then we would have reverted back to the agents and we would have asked them to provide more information.
Kantanshi Independent member of parliament Anthony Mumba: Honorable Chairperson…
Kunda: Yes Honorable Anthony Mumba, [is it a] follow up to the same?
Mumba: Yes, just to try and understand what Honeybee is saying. Are they agents or are they manufacturers for them to have agents across the world? Are they agents themselves, are they agents who are representing a particular manufacturer in a particular country or are those agents he is referring to responsible to Honeybee as a manufacturer? I just need that clarification, or are they themselves?
Kunda: It’s clear Honorable. Yes, director from Honeybee.
Zakiir: Thank you Honorable Chair, we are a company and these are our agents across these countries that I mentioned. So they act on our behalf, they act on behalf of Honeybee Pharmacy.
Kunda: So when you received those recommendation letters, looking at those recommendation letters, there is no address whatsoever. Were you satisfied that these are documents that you can present to a government ministry for you to get recognition that you, yes for sure you have supplied medicines to these countries that are referred to?
Zakiir: Thank you Honorable Chair, as I mentioned earlier that if additional information was required, we would have reverted back to the agents and…
Kunda: Yes but I am asking you, are these the kind of documents that you would be presenting to a government ministry for you to get a contract?
Zakiir: We are not very…
Kunda: For starters, I have not yet finished please switch off your microphone. For starters, there is no address, there is no address where we can say this is the letterhead that came from this place and we start thinking that maybe this is not authentic. So, are you satisfied that this is the kind of document that you would be presenting to a government department for you to get a contract?
Zakiir: Thank you Honorable Chair, when we were actually putting together the documents, we engaged a consultant and the consultant put together these documents, he used his expertise and that is how the documents, he was satisfied and that is how these documents were submitted. Kunda: You are now bringing in consultants but we are talking about Honeybee. This is Honeybee we are talking about, not a consultant. So, are you satisfied that a letterhead that is only written ‘Gauteng Province, health, Republic of South Africa’, that’s it. ‘Adventist development and Relief Agency, Malawi’, that’s all. Are those the kind of documents that you would present to a government of the Republic of Zambia’s Ministry to get a contract given to you?
Zakiir: Thank you Honorable Chair, at that moment when the documentation came, we were satisfied with the documentation and that is what we presented. I submit.
Kunda: Yes Honorable [Kasempa UPND member of parliament Brenda] Tambatamba
Tambatamba: Thank you very much Chair. The director is getting me very surprised, he says he was happy with the documentation that is so incomplete. My questions get directed to the life of this organisation; like how many years has Honeybee been in this business in Zambia, pharmaceuticals? How many years? And secondly, when was their last audit, when was their last audit for us to get to understand what kind of organisation where they can receive letters that are incomplete to present for a multi-million dollar contract. So how many years have they been in existence in Zambia in this business and when was their last audit? I thank you.
Kunda: Yes, before you come in Honorable Kasonso, I just want to just follow up on what Honorable Tambatamba has stated and in reference to the same letters because I am here with them. This is referring to Honeybee in China and not South Africa. Without any address, maybe I can read it so that we understand. “This is to confirm that M/S, which is Messrs, Honeybee Pharmacy of plot 232, Chinika, Industrial area Lusaka Zambia was awarded a tender for supply of 20,000 units of MS kits and they supplied the same within the stipulated time and as per the set specifications and conditions. We would not hesitate to recommend them to any of prospective customers including NGOs and government entities.”. Without knowing where it is coming from it’s just Gauteng Province. So, you received this letter and the last one is from Malawi, without any address. Are you satisfied. This is a document, I am repeating, this is a document or these are documents that you can present to a government ministry for you to get a contract? Please, be quick.
Zakiir: Thank you Honorable Chair, as I mentioned earlier, we got these documentations from the agents because we supplied through the agents into South Africa and into Malawi and these are the documentations that came and the consultant after receiving these documents, he was satisfied and the consultant…
Kunda: Okay that is clear, I think the ministry will be able to answer that…
To be continued in tomorrow’s edition.