November 21, 2001

    The Minister for Health and Family Welfare, Dr. C.P. Thakur, made the following statement in Rajya Sabha today on the incidents of death of children in Assam following administration of Vitamin-A:

    "The Ministry of Health and Family Welfare is concerned about the reported deaths and illness among children in Assam after they were given doses of Vitamin A in a state-wide campaign sponsored by UNICEF and organized by the State Government of Assam held on 11^th November, 2001. Information received from the State Government suggests that a large number of children had reported symptoms of side effects within a few hours after receiving the dose of vitamin A solution. Unfortunately, a few children also died. Until now, as per the State Government report dated 19.11.2001, about 953 children had shown adverse effects like vomiting after administration of Vitamin A. We have been informed that 14 children had died after the incident. However, a preliminary assessment indicates that in most of these cases, the death was due to causes unrelated to Vitamin A. The deaths have taken place due to diseases like cardiac failure, foreign body aspiration, severe anaemia, fever of indeterminate cause etc. In many of the cases the parents have reported that the deceased child had not been given any dose of Vitamin A. It seems that the panic created due to the side effects, has resulted in all deaths being attributed to Vitamin A. Samples of the drug have been collected by Drug Controller General of India for analysis and the results are awaited.

    Prima-facie evidence suggests that UNICEF had replaced the 2 ml spoons usually supplied with the Vitamin A solution with 5 ml cups for this round of campaign in Assam. One possibility is that during the campaign some children might have received doses in excess of the recommended level of Vitamin A resulting in symptoms of toxicity. However, experts will have to go into this issue and give their opinion.

    I would like to reassure the Hon’ble Members that Vitamin A given in the right dose is absolutely safe. Vitamin A is an essential Vitamin, the deficiency of which can lead to blindness. In addition, children with deficiency of Vitamin A re more prone to sickness like diarrhoea and pneumonia and are at a higher risk of death. It is for this reason that the Government of India is implementing a programme for administration of prophylactic doses of Vitamin A to young children since the 1970s without any adverse outcome. I would like to assure that Vitamin A solution used under the National Programme is a safe drug. However, like any drug, over-dosage can lead to problems. Although, an inquiry has been instituted by the State Government and the exact cause of the mishap in Assam will be known to us within a few days, preliminary information at this stage, seems to indicate that some children in Assam have suffered side effects of the drug due to alleged over-dosage.

    The Ministry of Health and Family Welfare had organized a large National consultation in September 2000 in which nutrition experts, pediatricians, public health experts, researchers and representatives from international organizations were invited. This National Consultation, which examined several issues related to vitamin A concluded that the magnitude of clinical vitamin A deficiency has declined significantly in the country, but it still exists as a public health problem in some pockets. The Consultation endorsed the National Policy of administration of Vitamin A and recommended that Vitamin A prophylaxis should be strengthened as a component of the primary health care services. Since at the time of the Consultation many States were linking Vitamin A campaigns with the Pulse Polio Immunization (PPI) this issue was also discussed at great length. The National Experts had recommended that it was inadvisable to link vitamin A supplementation with the PPI Programme. There are several reasons for this. Vitamin A dosage is age dependent and repeated dosages can lead to toxicity. In campaigns a very high degree of training and field supervision are required. This may not be possible since public health systems in many parts of the country are not yet capable of managing these complexities. Instead, the exports had opined that the routine programme for Vitamin A prophylaxis should be re-energized. The proceedings of the Workshop were communicated to all State Governments.

    We have since recommended to all States to refrain from launching campaigns not only for vitamin A but also for other individual interventions since campaigns have a tendency to divert the attention of the entire system from routine essential activities.

    The State Government has ordered an inquiry into the incident in Assam by a committee headed by Mr. M.S. Pangtey, Addl. Chief Secretary.

    I have constituted a high level Committee of Experts under the Chairmanship of Dr. N.K. Ganguly, Director General, ICMR to go into the various aspects of Vitamin A administration. The Committee has been requested to study several aspects related to Vitamin A including the programme and technical aspects related to the drug. I have requested the Committee to give its report and recommendations soon. I shall keep the House informed about the findings of the Committee."