[Ip-health] Drug shortage feared as Uganda govt, WHO haggle over supplier

[Jaya Banerji]

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Drug shortage feared as Uganda govt, WHO haggle over supplier



Written by HUSSEIN BOGERE & DEVAPRIYO DAS

Wednesday, 10 June 2009 16:53

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.

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