JUDGMENT P.P. Naolekar, C.J. 1. The Director of Health Services, Assam undertook a programme of administering Vitamin-A to the children of the age group of 1 to 5 years initially in the year 1999. The third round in the third phase of the said programme was carried out through out the State on 11.11.2001 in the financial and logistic support of UNICEF. A target of 31,74,278 numbers of children within one group of 1 to 5 years was laid down for the programme on 11.11.2001. The main objectives of the programme were- i) to reduce blindness, ii) to lower the risk of death in a child by 23 percent, iii) to reduce malaria attack by 40 percent, iv) to reduce mortality from diarrhoea by 40 percent, v) to reduce fatality death from measles, vi) protection from diseases and infection for growth and development of children. The programme for 11.11.2001 was designated as the third round of the third phase of pulse Vitamin-A campaign. The first phase of this campaign had been earlier conducted only in the districts of Kamrup and Barpeta on 24th October, 99 as a pilot project. The second phase of the said campaign was conducted on 26th March, 2000 in the districts of Kamrup, Bongaigaon, Nagaon, Sonitpur and Darrang. The third phase had two eariierrounds, the first round having being conducted on November, 2 000 and the second round on 3rd June, 2001. The administrations of pulse vitamin-A during first and second phase and first and second rounds of the third phase did not have any adverse report involving illness or death of children. However, as soon as the third round of the third phase of the administration of Vitamin-A to children was conducted on 11th November, 2001, a number of reports started coming in from the districts about children falling ill with various complaints and also of death of a number of children. The death reported after the third round of the third phase of the campaign was 23. A number of enquiries were conducted into the incidents of death district wise by the district administration concerned, health officials and representatives of UNICEF into the causes and extent of the deaths and illness of the affected children.
The death reported after the third round of the third phase of the campaign was 23. A number of enquiries were conducted into the incidents of death district wise by the district administration concerned, health officials and representatives of UNICEF into the causes and extent of the deaths and illness of the affected children. The Petitioners did not find satisfactory answer to the death caused by administration of Vitamin-A doses to the children within the age group of 1 to 5 years and for the illness of large number of children who have been administered Vitamin-A under the programme, approached the High Court by filing the present petition praying for amongst other things, an enquiry by an independent body into the cause and reasons for death and sickness of children following administering PulseVitamin-A solutions in the UNICEF sponsored programme; to provide adequate compensation to the near relatives of the children who have died and have fallen sick out of administering of Pulse Vitamin-A and for a direction to the authorities to take appropriate measures in future programmes to ensure that such tragedy do not occur. 2. The Division Bench of this Court by interim order dated 5.6.2002 directed the Director General of Police, Assam to have an enquiry conducted by an officer not below the rank of D.I.G. (C.I.D) who has submitted its report on 25.10.2002. The enquiry was conducted keeping in view the allegations made in the writ petition as well as the directions issued by the Gauhati High Court and taking into consideration issue of public interest involved in the matter. For the purposes of enquiry the spread was on the following points- (1) Was the vitamin-A solution administered free of contamination? (2) Did the cases of illness and death of the affected children have any cause and effect relation with the administration of Vitamin-A solution on 11th Nov/2001? (3) Was the infrastructure for the conduct of a programme of such a magnitude strong enough to bear it? (4) Was the preparation including training of workers sufficient for the o ne day programme? (5) Was there any fault during the actual conduct of the programme? (6) Was there any misappropriation or corruption in respect of funds? (7) Was there any negligence in taking care of children falling sick after administration of the solution?
(4) Was the preparation including training of workers sufficient for the o ne day programme? (5) Was there any fault during the actual conduct of the programme? (6) Was there any misappropriation or corruption in respect of funds? (7) Was there any negligence in taking care of children falling sick after administration of the solution? The Commission has gone into the questions whether Vitamin-A solution administered was free of contamination and after going through various factors the Commission has reached the conclusion that so far as the quality of the Vitamin-A solution was concerned there is nothing to show that it was contaminated or adulterated. The said solution stood the test of several independent Govt. and non-Governmental bodies and had there been anything wrong with it, it would have been detected immediately. On the second issue the commission has noted the cases of death of the 23 children, after administration of Vitamin-A in the one day programme on 11.11.2001, as provided by the State Health Department, as follows- 1. Asha Bhagti (2 years) Dist. Cachar: The Health authorities attribute the death to severe academic state of the child. She is also reported to have been suffering from vomiting, gastrointestinal disturbances on 10.01.01. The post mortem report does not give any cause of the death. The viscera report from the FSL Guwahati given negative test for any poison but positive test for Vitamin-A. 2. Lucky Begum (1 year 2 months) Dist. Cachar Death has been attributed to nausea, vomiting and diarrhoea that appeared after 36 hours of administration of Vitamin-A. P.M. examination was done. The Department of Forensic Medicine, Silchar Medical College opined that the death was due to pneumonia. Forensic examination of viscera gave negative tests for common poison and positive test for Vitamin-A. 3. Payal Das, (5 years) Dist. Cachar The patient was extremely emaciated. She was not taking food for 4/5 days prior to her death on 14.11.2001. Postmortem examination was not done. The reason for death given by the attending doctor w as cardio respiratory failure. 4. Rohima Begum, (4 years) Dist. Cachar The child has been stated to have been suffering from general illness and had not taken any food for 4 days prior to her death on 31.11.2001. Local enquiry indicates that the child vomited and had loose motions several times since 3/4 hours after the administration of the medicine.
4. Rohima Begum, (4 years) Dist. Cachar The child has been stated to have been suffering from general illness and had not taken any food for 4 days prior to her death on 31.11.2001. Local enquiry indicates that the child vomited and had loose motions several times since 3/4 hours after the administration of the medicine. No medical treatment was given to her. No post mortem was done. 5. Hemlata Bania (3 years) Dist. Nagaon The child had been suffering from fever since 9.11.2001. It died on 12.11.2001 after a bout of vomiting. Screamed on a high pitch three times before dying. Post mortem examination was not done. The guardian feels that the child died over sickness. 6. Wahidur Rahman, (2 years) Dist. Nagaon The child was suffering from viral fever and treated at Dhing PHC, had occasional vomiting, cough and diarrhoea. The medical opinion is that it died of acute respiratory tract infection. Post mortem was done but no definite opinion given. 7. Nazima Begum, (4 years) Dist. Morigaon Local enquiries indicated that the child developed stomach pain, vomiting and loose motion after 22 hours of the administration of Vitamin-A. Not treated by any Doctor. No post mortem examination was done. 8. Amol Bordoloi (2 years) Dist. Morigaon After one hour of the administration of Vitamin-A solution the child developed diarrhoea etc. and died the same day. Post mortem was not done. 9. Mousama Begum (1 year 6 months) Dist. Morigaon Within two hours of administration of Vitamin-A the child developed loose motion and died on the same day. Post mortem examination was not done. 10. Palash Medhi (1 year 6 months) Dist. Nalbari The child developed fever and loose motion within 20 hours of the administration of Vitamin-A and died one day later. Not treated by any doctor. Post mortem examination was done following registration of a U.D. Case at Nalbari P.S. The post mortem report gives the cause of death as dehydration. The child was not treated b y any doctor before its death. 11. Nitu Das (2 years) Dist. Nalbari Vitamin-A was not administered. The child was suffering from post measles complication and a doctor examined and treated it. Post mortem examination was not done. 12. Rubul Baishya, (2 years) Dist. Nalbari Local enquires indicate that about 4 hours after the administration of Vitamin-A the child developed fever and a doctor treated it.
11. Nitu Das (2 years) Dist. Nalbari Vitamin-A was not administered. The child was suffering from post measles complication and a doctor examined and treated it. Post mortem examination was not done. 12. Rubul Baishya, (2 years) Dist. Nalbari Local enquires indicate that about 4 hours after the administration of Vitamin-A the child developed fever and a doctor treated it. The doctor did not give any opinion about the cause of death. No post mortem was done. The Addl. C.M. and H.O. Nalbari opined that the death was due to acute respiratory infection. 13. Rupam Ora, (7 months) Dist. Sonitpur Local enquiries indicate that the child was administered Vitamin-A and there was no change in its health for that; however the Addl. C.M. and H.O., Sonitpur states that it died due to obstruction of airways caused by foreign body intake stated to be a piece of betelnut. No post mortem examination was done. However, since the programme was for children in between one and five years of age, administration of Vitamin-A to it was nothing but a repudiation of the norms laid down for the campaign. The Addl. C.M. and H.O. Sonitpur is answerable for this. 14. Azizul Haque (1 year) Dist. Sonitpur On local verification and as per statement of the Addl. C.M. and H.O., Sonitpur, the child was not administered Vitamin-A. It was supposedly suffering from gastroenteritis. No post mortem examination was done. 15. Reshmina Khatun (3 years 3 months) Dist. Sonitpur The child had vomiting trouble that started after 6 days of administration of Vitamin-A and it died on 18.11.2001 No post mortem examination was done. The Addl. C.M. and H.O. states that it died of acute respiratory tract infection coupled with malnutrition. 16. Dulur Hasda (5 years) Dist. Kokrajhar The child had vomiting problem after 24 hours of the administration of Vitamin-A. It died four days later. A U/D case was registered and P.M. examination done which did not indicate the cause of death. 17. Tale Hasda (3 years) Dist. Kokrajhar The child had vomiting problem after 24 hours of taking Vitamin-A. He died four days later. A U/D case was registered and P.M. examination was done. No definite opinion was given. Bijoy Topo(3 years) Dist. Kokrajhar It developed vomiting and loose motion after 48 hours of taking vitamin-A. A U/D case was registered and post mortem done. No specific cause of death has been cited.
A U/D case was registered and P.M. examination was done. No definite opinion was given. Bijoy Topo(3 years) Dist. Kokrajhar It developed vomiting and loose motion after 48 hours of taking vitamin-A. A U/D case was registered and post mortem done. No specific cause of death has been cited. 19. Bina Chetia (2 years) Dist. Sivasagar The child developed symptoms of vomiting after 4 hours of taking Vitamin-A. Local enquiries put the cause of death on gastroenteritis and vomiting. No P.M. examination was done. 20. Jagannath Keot, (3 years) Dist. Sivasagar The child started vomiting after 2 hours of taking Vitamin-A. It was given treatment by the Doctor-in-charge, Sapekati PHC. Death was attributed to existing ailments of the child. No post mortem examination was done. 21. Jan Das (5 years) Dist. Sivasagar The child died after three days of taking Vitamin-A. Death is attributed Nephritis. Post mortem examination was not done. 22. Isa Tati @ Rupamani Tati (2 years) Dist. Dibrugarh Vitamin-A was not administered. Death has a been attributed to fever. No post mortem was done. 23. Anita Tappu, @ Emansia Tappu (1 year 6 months) Dist. Dibrugarh The Addl. C.M. and H.O. Dibrugarh has attributed the death to fever. Local enquiry also says it was fever. No post mortem was done. 3. From the aforesaid reports submitted before the Health Department it appears that in most of the cases of post Vitamin-A death the child had been suffering from some existing ailment or malnutrition. It also revealed that in none of the cases in which post mortem examination was done, the post mortem report or the FSL report on viscera has attributed the cause of death to Vitamin-A solution. But it appears that the administration of Vitamin-A did induce certain common symptoms in the children with a differing time gap in individual cases. The commission has found that the infrastructure for conduct of the programme by the Health Department down to the district and PHC level worked satisfactorily and programme went ahead without breakdown. 4.
But it appears that the administration of Vitamin-A did induce certain common symptoms in the children with a differing time gap in individual cases. The commission has found that the infrastructure for conduct of the programme by the Health Department down to the district and PHC level worked satisfactorily and programme went ahead without breakdown. 4. While considering the issue whether the preparation including the training of workers were sufficient for the one day programme the commission has noted the expert opinions on the implications of the application of Vitamin-A on children of various categories, like those on a healthy child, a malnourished child, a child suffering from some ailments or a child who is both malnourished and sick and has made reference to the expert opinion which are as under: The intake of Vitamin-A is both for prophylactic (preventive) purposes and for treatment of variety of illness. However, excessive consumption of the Vitamin-A can cause toxic manifestations. Also known as antioxidants, Vitamin-A is necessary for growth and repair of body tissue. The three general functions of Vitamin-A are in maintaining the integrity of the epithelium, promoting synthesis of sterols and preventing night blindness and weak eyesight. Excessive Vitamin-A intake results in a toxic syndrome known as hypervitaminosis-A. Vitamin-A toxicities in human may be generally categorized as either acute or chronic. Acute toxicity occurs following ingestion of high doses of Vitamin-A . It may occur within hours or at most a day or two after a very large intake. Since Vitamin-A is stored in the liver, chronic ingestion of mega doses may result in hepatic toxicities. The range of Vitamin-A doses leading to liver damage vary from 15,00,000 I.U. per day. In patients with renal failure as little as 4,00,000 I.U. per day has been known to cause substantial liver damage. Children may develop hypervitaminosis-A with chronic doses of only 10 times of the recommended dietary allowances for vitamin-A an example of such a case occurred in a one year old boy who received 6,00,0001.U. Vitamin-A daily for three months. Acute Vitamin-A toxicity occurs when an infant ingests more than 3,00,000 I.U. Among other things, a child may develop any such symptom like case of vomiting and drowsiness. Did Vitamin-A kill the children in Assam as reported "Almost certainly not, even twice the intended prophylactic is not lethal but would have caused mildxeropthalmia.
Acute Vitamin-A toxicity occurs when an infant ingests more than 3,00,000 I.U. Among other things, a child may develop any such symptom like case of vomiting and drowsiness. Did Vitamin-A kill the children in Assam as reported "Almost certainly not, even twice the intended prophylactic is not lethal but would have caused mildxeropthalmia. Critics have chosen to ignore the mortality rate of 1-5 year olds per thousand children per year. Thus among the estimated 2.5 million children (sic) in the Vitamin-A campaign, 17,500 would be expected to die over the coming year including 48 deaths the very next day. The report of the committee under the Chairmanship of Shri NK Ganguly, Director General, Indian Council of Medical Research constituted on the wake of death of children in the Vitamin-A campaign in November 2001 has said regarding Vitamin-A toxicity. A review of the available literature indicates that a cute toxicity results from high doses (5,00,000 I.U.) Consumed over a short period. Occasionally children may experience mild side effects like loose stools, headache, irritability, fever, nausea and vomiting after a large dose of about 2,00,000 I.U. of Vitamin-A. The incidents of such adverse mild symptoms has been about 15 per cent to 7 percent depending on the age of the child. When a large number of children were given Vitamin-A on the same day, even one percent with side effects would be much enough to create panic. These side effects are transient. The incidents of side effects in Assam following Vitamin-A administration ranged from 0.29 percent to 0.48 percent. The lower rate of side effects in Assam maybe real or due to variations in methods of data collection. Vomiting, nausea and diarrhoea were predominant symptoms reported in Assam. 5. The commission has found that the UNICEF has replaced the traditional 2 ml. spoons with 5 ml. cups to pour out Vitamin-A during the campaign and it was suspected that the new system of measuring Vitamin-A coupled with inadequate training of health workers had led to over doses. The commission has found that even if some amount of overdosing had taken place by an extra one or 2 ml. more, it could not have caused death and sickness of the children in the scale it had happened. In the previous rounds and phases of the same campaign post administration effect has not been reported.
The commission has found that even if some amount of overdosing had taken place by an extra one or 2 ml. more, it could not have caused death and sickness of the children in the scale it had happened. In the previous rounds and phases of the same campaign post administration effect has not been reported. The commission has made certain suggestions like making fresh study by the NUICEF, World Health Organization, the Union Ministry of Health and Family Welfare and the State Health Department of the effect of the moderately toxic Vitamin-A solution on seriously sick children if administered. The commission has found that there was a defiance of the laid down norms while administering the Vitamin-A on account of the negligence of the health workers and medical officers concerned and reasonable care should have been taken before administration of Vitamin-A. 6. Claim in public law for compensation for contravention of human rights and fundamental freedoms, the protection of which is guaranteed in the Constitution, is an acknowledged remedy for enforcement and protection of such rights, and such a claim based on strict liability made by resorting to a Constitutional remedy provided for the enforcement of a fundamental right is distinct from and in addition to the remedy in private law for damages for the tort resulting from the contravention of the fundamental right. The relief of monetary compensation, as exemplary damages, in proceedings under Article 226 by the High Court, for established infringement of the indefeasible right guaranteed by Article 21 of the Constitution, is a remedy available in public law. Therefore, when the court exercises its power for granting compensation in the nature of matter, which has been brought before us, the Court does so under the public law by way of penalizing the wrongdoer and fixing the liability for the public wrong on the State which has failed in its public duty to protect the fundamental rights of the citizen. Compensation awarded cannot be misunderstood as damages under the private law, but it is a relief provided by the Court from the wrong doer, by ordering payment of monetary compensation under public law for the wrong done due to breach of public duty of not protecting the fundamental rights of the citizen.
Compensation awarded cannot be misunderstood as damages under the private law, but it is a relief provided by the Court from the wrong doer, by ordering payment of monetary compensation under public law for the wrong done due to breach of public duty of not protecting the fundamental rights of the citizen. The award of payment of exemplary damages against the wrong doer for breach of its public law duty is certainly independent of the rights available to the aggrieved party to claim compensation under the private law in an action based on tort, through a suit instituted in a court of competent jurisdiction or/and prosecute the offender under the penal law. 7. In the present case, it is apparent as per the report of the commission that the UNICEF has replaced the normal 2 ml. spoons with 5 ml. cups to pour out Vitamin-A during campaign. The Officials of the State or the Health Workers in charge in carrying out the administration of Vitamin-A dose to the children has not taken adequate care and have also not been looked into the effect which would be caused by administration of Vitamin-A to the seriously sick children and thus there lies some amount of carelessness on the part of the State officials. The State Government had not provided any guidelines to the Health workers and the officials of Health Department regarding the administration of dose and/or whether such dose of Vitamin-A can be administered to the sick children. Under the circumstances, we are of the view that there is some amount of negligence on the part of the officials of Health Department in carrying out the programme on 11th November 2001 of Pulse Vitamin-A Campaign and the State cannot shirk its responsibility of giving redressal to some extent to the families of the children, who had died, by payment of exemplary damages. In the present case, the learned Advocate General appearing for the State has informed that a sum of Rs. 5,000/- each have been paid to the family of 23 children mentioned hereinabove, who died after the 11th November 2001 Campaign of Administration of Pulse Vitamin-A. 8. Considering the factor of death of innocent children, we feel that the amount of compensation already paid as exemplary damages for the death of small children is not adequate and, therefore, we direct that an additional amount of Rs.
Considering the factor of death of innocent children, we feel that the amount of compensation already paid as exemplary damages for the death of small children is not adequate and, therefore, we direct that an additional amount of Rs. 20,000/- (Twenty' thousand) be paid to the families of the children who had died after the administration of Pulse Vitamin-A on 11th November 2001 and whose names appeared hereinabove. The amount shall be paid within a period of one month from the date of this order. 9. It is further directed that henceforth whenever such campaign is taken for administration of Pulse Vitamin-A to the small children the State authorities shall make adequate publicity campaign giving due publicity of shortcoming and the hazards of administration of Vitamin-A dose to the children suffering with serious ailments. The State Government shall issue necessary guidelines to the Public Health Workers in regard to administration of Pulse Vitamin-A dose to different age groups of children. The State shall adopt some method, which could effectively distinguish sick children from the healthy children before administration of Pulse Vitamin-A to the small children. With the aforesaid directions the writ petition stands disposed.