Thousands die as MCC stall on registration of Vitamin A capsules

Poor co-operation between the Medicines Control Council and the Department of Health along with unnecessary stalling has allowed tens of thousands of children to continue to suffer Vitamin A deficiency in this country, a condition that has seen thousands die because their immune systems are compromised.

A UNICEF survey conducted in 1993 found that 30% of South African children under six (between 10 000 and 20 000 children) were vitamin A deficient.  

Further studies found that vitamin A supplementation could reduce mortality by almost a quarter and it has been accepted by the World Health Organisation as one of the most cost-effective interventions.  

A study done in Tanzania also showed that vitamin A supplementation reduced mortality by more than 60% among HIV-infected children between 6 months and 5 years. In South Africa supplementation of HIV-infected children with vitamin A was found to reduce diarrhoea morbidity and to improve children’s immune status.

However, bureaucratic red tape and unnecessary delays in the registration of vitamin A capsules has previously seen government award a tender of R2,30 a high dose (200 000 unit) capsule, instead of 13 cents for the more suitable lower doses preparation should it be manufactured locally.

Recently the tender was awarded at a cost of 45 cents a 200 000 unit capsule (still 320% too high).

Two local manufacturers have indicated that should the MCC register the strengths required by children, they would be in a position to sell it at a cost of between 12 and 13 cents per capsule for lower dose vitamin A.  

According to frustrated doctors, health workers and industry sources, they have been trying since last year to fast track the registration of the 50 000 and 100 000 unit low dose vitamin A capsules.

Despite assurances by the MCC and letters from the Department of Health to the Registrar of Medicines, none of these has been registered.

Professor David Sanders, head of the Public Health Programme at the University of the Western Cape, accused the MCC of being “very passive”.  

Sanders said there was no financial incentive for pharmaceutical companies to apply for the lower dose vitamin A to be registered as it is only really needed for poor and undernourished children.

The MCC demands a fee of R50 000 to be paid for any registration application.

However, Dr Jon Rohde of the Equity Project in the Eastern Cape, said most countries only use the 200 000 capsule. They cut off or puncture the tip and drip half into the infant’s mouth.

Studies have shown that vitamin A deficiency delays recovery from infections and can cause eye damage, such as dryness of the conjunctiva and cornea and ulcers, and when severe, can cause blindness.  

Vitamin A deficiency can cause anemia and research findings suggest that vitamin A deficiency in pregnancy increase a woman’s risk of dying during pregnancy and the first three months after delivery.  

Dr Michael Hendricks and Sonja Giese, of the Department of Paediatrics and Child Health Unit at the University of Cape Town, agree that conservative estimates suggest that Vitamin A supplementation is the single most significant action that could be taken in South Africa at this time to reduce infant and young child mortality.

A Child Health Unit study in 1998 found that a vitamin A supplementation programme would cover 74% of the target population (children 6 to 24 months) by distributing through primary health care facilities as part of the Expanded Programme on Immunisation.

The study showed that as the programme would be implemented as part of the existing health services, it would cost R5,3-million nationally, with the exclusion of personnel cost.

The vitamin A capsules would account for R770 000 of this total cost.  

But despite the overwhelming evidence that South Africa could only benefit from this affordable intervention, the Department of Health appears to lack a sense of urgency.

Acting director for nutrition, Cynthia Mgijima said the policy of the department was that Vitamin A’s registration should be fast tracked, but that this responsibility lay with the MCC.

She said a new tender has been awarded for the higher dose capsule.  

Failing to expand on why Vitamin A was still not be being supplied or why the department was not putting more pressure on the MCC, Mgijima simply said they could not supply unregistered products.

Rohde said pharmaceutical companies were not prepared to manufacture the lower dose capsule unless they could be guaranteed a market to sell it.  

He said one had to ask the question how many children had died up to now because of vitamin A deficiency.

“I don’t know, but the Eastern Cape has an overall infant mortality rate of 60 per 1 000 births for regions A and C (Port Elizabeth and East London) and 99 per 1 000 in region E (Mount Frere) – a figure 1,5 times that of   Bangladesh or India.

“Studies all over the world have shown an average mortality decline of 23% with vitamin A given in deficient areas – in the Eastern Cape that would be conservatively a fall from 60 to 45 per 1 000 (the national average is 40).

With 180 000 births per year, that means we could have saved 2 700 infants per year or 20 000 infants in the Eastern Cape in the past 7 years, and that is infants only,” Rohde said.

The late Abraham Horwitz, chairman of the International Vitamin A Consultative Group said in 1993 that: “The persistence of vitamin A deficiency anywhere in the world is cruel, because it exposes mothers and children to great risks; it is immoral because it ignores basic human values; and it is unacceptable because it is preventable.”  

The MCC could not be reached for comment.


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