A murky procurement process to supply anti-malaria drugs to the national health system is at the core of the worsening shortage of drugs in the country. The Observer has learnt that Uganda is about to award a major tender to supply ACTs (Artemisinin Combination Therapies) to an Indian consortium that the World Health Organisation warns has a poor delivery record. On the advice of its procurement agent, Crown Agents, and its contract review committee, the government is likely to award the tender to Ajanta Pharma Ltd., an Indian consortium.The Observer has, however, learnt that Ajanta not only failed to deliver the capacity that was required in Kenya of 12 million doses, but the company also received a ‘Notice of Concern’ from the World Health Organisation for failure to comply with specified standards related to good manufacturing practices—raising eyebrows amongst stakeholders. According to WHO, Ajanta wasn’t able to provide sufficient assurance that validation and qualification was fully implemented to an acceptable level of compliance with current WHO norms and standards.
Ajanta is also accused of not following its quality systems to prevent possible cross-contamination in a consistent manner, that the company failed to exercise sufficient control over some materials, and that the company was unable to provide sufficient reliable documented evidence of process validation, including but not limited to source data for quality control and analytical test results.
The WHO says it will withhold prequalification of drugs made by Ajanta until safety concerns have been satisfactorily addressed.
“In addition, if these major observations are not corrected within a reasonable framework, WHO may consider suspension of the product(s) listed as pre-qualified from this manufacturing site, and/or may recommend suspension of procurement of all prequalified products manufactured on this site,” said Dr. Lenbit Rago, WHO’s Quality Assurance Coordinator, in a letter dated March 24.
The letter followed WHO’s inspection of Ajanta’s facility and issuing of an inspection report which the company was expected to respond to within 30 days.
WHO said it had received and evaluated Ajanta’s response but some issues of concern had not been “adequately addressed.” It is not clear whether the Ministry of Health in Uganda was briefed about this situation, but what is known is that officials in Kenya made efforts to inform their Ugandan counterparts.
Dr. Stephen Malinga, the Minister of Health, told The Observer that Uganda was made aware of the Kenyan situation which he however said was caused by the Kenya Government itself.
“They have explained themselves and they seem to think that it was the Kenyan Government that caused delay in supplying the medicines which led to stock-outs; it was not their problem. They say they can supply fully and we were assured by Crown Agents—our agents in procurement - that they can supply.”
But information available to The Observer shows that Ajanta’s problems were more than packaging.
According to an e-mail from a Ministry of Health official in Kenya, numerous boxes from Ajanta “were found to be with less than 40 doses as said, mixed labeling... external and internal packaging saying the doses contained therein is 6 x 18’s or 6 x 24s then one finds only 6 X 6s”.
“Given all these, we feel they are cheating us out of the paid for medicines. It is particularly bad when one budgets for the higher doses and packages are delivered stating they contain the same only to discover they are full of the smaller dosage packs,” said the official who preferred anonymity, writing to the Kenya Government.
That came on top of Ajanta’s failure to deliver the 12 million doses needed; it could only manage a maximum of 200,000 to 400,000 doses at a time. This, according to the Kenyan official, effectively erased the last 2-3 years of positive achievements in Kenya’s malaria control programme.
Global Access, a stakeholder in the fight against Malaria, were astounded by the news that Ajanta had won the tender to supply Uganda with 17 million doses of artemether-lumefantrine, Kenya’s problems notwithstanding.
It seems the Ministry of Health awarded the contract on purely economic basis because WHO is yet to make a report of its assessment of Ajanta’s site following the issuance of the notice of concern.
According to Dr. Richard Ndyomugyenyi, Programme Manager (Malaria), Ministry of Health, the signing of the contract with Ajanta will hinge on that WHO report.
“WHO will give us their assessment report and then after that we are going to sign a contract if the assessment report is in favour of Ajanta. To me, a difference of one million dollars; that’s a good saving for us if Ajanta delivers [the closest bidder being Novartis].
They got this contract through proper procurement procedures and we need always to be transparent,” Ndyomugyenyi said. But more questions have arisen, especially about Ajanta’s capacity to deliver the needed drugs, and the flaunting of some regulations during the bidding process. Between March, when the official tender bid was presented, and May when the final bid was accepted, Ajanta increased its price to $17.9 (FROM?) as confirmed by the bid evaluation copy seen by The Observer. If this interpretation is accurate, then it would indicate a clear violation of tender rules – a manufacturer cannot tweak its bid after the official submission, and questions could be raised as to why they would want to sweeten the deal in any event.
Ndyomugyenyi insisted that MOH is convinced Ajanta can pull off the delivery, the first of its kind to Uganda. “We discussed this at length and they are going to make a contract with Ajanta which will be phased. If they fail on the first phase, then the contract will be cancelled. I don’t think we should start panicking before we see whether they are going to deliver or not,” he said.
While the Global Fund Inspector General wants to learn more about the details of the situation at hand, up until now, the Global Fund – whose funds are paying for this transaction – has not made any attempts to exclude Ajanta from tenders financed by the Fund, even though the Kenyan situation has not yet been resolved satisfactorily.
The malarial drugs are meant to fill the shortage that has been ongoing since 2008, although the Ministry of Health prefers to attribute the shortage to “poor planning” on the part of the districts.
“It’s the districts which sometimes make mistakes in ordering, but as far as we know, the medicines are there. They delay in ordering, they wait until the medicines are finished and then they order. They should anticipate stock-out and order before time,” Malinga said, without revealing the districts.