(Per : HONOURABLE MR.JUSTICE J.B.PARDIWALA) This writ-application under Article 226 of the Constitution of India is in the nature of a Public Interest Litigation and has been filed by one Babulal Mangaljibhai Thakkar, a resident of Ahmedabad, seeking appropriate writ, order or direction on the respondent-authorities to include Polymerase Chain Reaction (PCR) Test in the standard H.I.V. (Human Immuno Deficiency Virus) testing for blood transfusion in order to detect HIV infection.
At the very outset, we may state that vide our order dated September 26, 2012, we directed to delete the name of the writ-petitioner-in-person from the cause-title as we were of the view that the credentials of the writ-petitioner appeared to be doubtful from his act of writing a letter to the Director General of Police, Government of Gujarat, Gandhinagar, by an E-Mail praying for registering a First Information Report under Sections 269, 270, 274, 302, 304, 308, 324, 120(B) and 114 of the Constitution of India and Sections 7, 8, 13(1)(a) and 13(1)(d) of the Prevention of Corruption Act against Mr.Manmohan Singh, Prime Minister of India, Mrs.Sonia Gandhi, Shri Sayan Chatterjee, Director General, National AIDS Control Organisation, New Delhi and 31 departmental heads of National AIDS Council.
We had deleted the name of the writ-petitioner in person from the cause-title as he had affirmed an affidavit justifying his action. However, considering that the issue is a very serious in nature of a public cause, we decided to look into the matter in detail and, accordingly, we appointed Mr.Shalin Mehta, the learned Senior Advocate as Amicus Curiae to assist this Court.
I.
CASE MADE OUT IN THE PETITION :
According to the writ- petitioner, the HIV (Human Immuno Deficiency Virus) is the virus that causes AIDS. This virus is passed from one person to another through blood, using shared needles and sexual contact. In addition, infected pregnant women can pass HIV to their baby during pregnancy or delivery, as well as through breast-feeding. People with HIV have what is called HIV infection. Most of these people develop AIDS as a result of HIV infection.
4.1 A National Blood Policy has been formulated and is now being implemented with the mission to ensure easily, accessible and adequate supply of safe and quality blood collected from voluntary non-remunerated regular blood donors.
4.2 The Drugs and Cosmetics Act provides mandatory testing of blood for five major infections, viz. HIV, Hepatitis B, Hepatitis C, Syphilis and Malaria. Every unit of blood is tested for all these infections. According to the National Blood Safety Programme of National AIDS Control Organisation (for short 'NACO'), it is mandatory on the blood banks to test every unit of blood properly for grouping, cross-matching and testing for HIV, Syphilis, Hepatitis B, Hepatitis C and Malaria before it is issued for transfusion.
4.3 According to the writ-petitioner, for treatment in hospitals, the patients need blood. Blood saves life but if that blood is given without requisite test, in particular HIV test, then it can prove to be dangerous for life and, therefore, proper blood test is a must.
4.4 According to the procedure of the standard testing of HIV, the test is restricted to Elisa i.e. Anti body test, is being undertaken. According to the study of the medical science, the length of time following the infection of an individual to develop detectable antibodies is about three months after the infection. This is called the "window period".
There is no provision to identify virus during the window period, unless special test known as Antizen test is conducted through Polymer Chain Reaction (for short 'PCR') method. Under the Elisa test, the virus cannot be idenfied during the window period i.e. during three months of infection. The foundation of this petition is a newspaper report published in the Times of India dated November 30, 2006, wherein it was declared that India became the first country in Asia to introduce DNA Polymerase Chain Reaction (PCR) test, a dry blood sampling method of testing for paediatric AIDS. According to the writ-petitioner, India has become the first country in Asia to introduce PCR test, then why such a test is not being conducted. The only test carried out by the State as well as Union is Elisa and not the PCR.
4.5 According to the writ-petitioner, when the PCR test is easier to be conducted and result could be received within 16 hours and the present Elisa Test is unable to detect the HIV for at least three months (Window Period), then in such circumstances, necessary directions deserve to be issued on the authorities to introduce PCR test mandatorily.
4.6 The writ-petitioner has cited the instance of the unfortunate event that had occurred at Junagadh Civil Hospital some time back, whereby 23 Thalaseimic children got HIV infection at the time of blood transfusion.
4.7 According to the writ-petitioner, the blood donated by one saves life of another. Donation of blood is a noble cause and in order to achieve such objective, all necessary safeguards must be achieved while collecting blood samples, otherwise instead of saving the life, the contaminated blood would take away the life. In such circumstances, it is not disputed that during window period, unless the special test known as Antizen is conducted through PCR method, the virus cannot be identified. According to the writ-petitioner, the Government must ensure that in all blood banks, the PCR method is available to identify the virus of HIV during window period.
II.
STANCE OF THE LEARNED AMICUS CURIAE :
Mr.Shalin Mehta, the learned Senior Advocate appearing as Amicus Curiae, relying upon the voluminous research material, submitted that the PCR test detects the genetic material on HIV itself and can identify the HIV in blood within two to three weeks of infection. Mr.Mehta submitted that babies born of HIV positive mothers are tested with a special PCR because their blood contains their mothers' HIV antibodies. This is suggestive of the fact that they would test the HIV positive on a standard antibody test but a PCR test can determine as to whether the babies have HIV themselves. According to Mr.Mehta, the blood supplies in most developed countries are screened for HIV using PCR tests. The PCR tests are also used to measure viral load to the people who are HIV positive. According to Mr.Mehta, the following are the different types of HIV tests.
TYPE OF TEST WHAT THE TEST LOOK FOR?
RNA/DNA Antigen Antibody PCR/Viral Load ● P24 only test(Ag) ● 4th generation, antigen/antibody(Ag/Ab) tests (p24+ ELISA, ELI, MEIA/ELFA/ECLIA) : includes Architect, Duo, Combo/Combi etc ● ● 1st/2nd/3rd generation antigen only tests (ELISA, ELI, MEIA/ELFA/ECLIA) : includes TriDot etc ● Rapid tests : finger prick and oral swab test are antibody only : includes OraQuick.
● Western blot tests look for antibodies to specific HIV proteins. They confirm a positive HIV antibody test result.
● *Viral genetic material 5.1 Mr.Mehta explained the window periods and HIV testing as under :
WINDOW PERIODS AND HIV TESTING :
In HIV testing, the window period refers to the time interval between the point when a person is infected and the point when laboratory tests can detect HIV infection. Understanding the window period of HIV tests is important for health care providers to provide appropriate information to clients during pre-and post-test counseling, when interpreting HIV test results, and when discussing testing or re-testing with clients following an event or potential exposure to HIV.
The most common HIV tests used are based on the detection of three biological markers of HIV infection which appear at different times following HIV infection (figure1) : viral RNA, p24 angtigen (a viral core protein), and HIV-specific antibodies.
Progress in HIV testing technologies continues to result in tests with shorter window periods. A potential benefit of the shorter window period is the reduction in the time interval for testing following a risk event or exposure, which can reduce client anxiety. Additionally, earlier diagnosis of HIV infection benefits both individuals and populations in the following ways:
Individuals who are diagonsed with HIV can be connected earlier to HIV-related primary care.
Persons who are aware that they are infected with HIV will often take steps which will prevent HIV transmission to others.
Earlier testing can diagnose individuals in the actue phase of their infection, within the first 4-6 weeks after infection, when a person often has a very high viral load and there is a greater likelihood of transmitting HIV to others compared with individuals in later stages of HIV infection.
5.2 According to Mr.Mehta, there are following additional HIV Testing Technologies under evaluation :
ADDITIONAL HIV TESTING TECHNOLOGIES UNDER EVALUATION :
The Provincial Public Health Reference Laboratory at the BCCDC, in partnership with the STI/HIV Division, is currently evaluating the use of pooled RNA NAAT testing in diagnosing acute HIV infection. Pooled RNA NAAT testing is currently under evaluation as part of a CIHR team grant focuesed on the use of the test at lcinics accessed by gay men for HIV testing and is currently performed only from specimens at these clinics.
Pooled RNA NAAT testing, currently used by Canadian Blood Services to screen donated blood, pools specimens from individuals with non-reactive 3rd generation EIA tests. Pools are then tested using RNA NAAT testing. If any pool is positive and viral RNA is detected, then the individual specimens are tested to identify the RNA positive specimen using individual RNA NAAT.
This test identifies people who have acute HIV infection and are RNA positive, but still antibody negative. In STI clinics where pooled RNA NAAT testing has been added to standard HIV testing, the number of individuals newly diagnosed with HIV infection has increased by between 3 and 11%. the window period of pooled RNA testing is approximately 10 to 12 days.
5.3 Mr.Mehta submitted that there are following diagnosis of maternal and neonatal HIV infection :
DIAGNOSIS OF MATERNAL AND NEONATAL HIV INFECTION :
Diagnosis of HIV infection neonates is complicated by the fact that infants acquire passively-transferred HIV antibodies from the mother; thus, EIA serologic testing cannot be used for confirmation of infection and RNA NAAT testing is used instead. Cord blood should not be used for neonatal diagnosis due to the risk of cross-contamination with maternal blood.
There is good correlation between a negative RNA NAAT test and the absence of HIV infection in the infant. A positive RNA NAAT test on at least two sequential specimens from the infant confirms infection. Infants in who HIV infection has been ruled out by RNA NAAT testing are usually followed up serologically for up to 2 years to document the loss of maternal antibodies.
RNA NAAT is available on request for screening anti-HIV negative high-risk pregnant women who are close to their date of delivery. Please refer to Oak Tree Clinic, BC Women's Hospital and Health Centre for guidelines regarding HIV testing and management in pregnancy.
5.4 Mr.Mehta submitted that there are following characteristics of HIV Tests currently in use at Provincial Public Health Reference Laboratory as on June, 2010 :
Test Description Use Estimated Window Period Assay used Name on test report 3rd Generation EIA test Enzyme Immunoassay which detects the presence of HIV antibodies.
Standard test protocol, at screening test (first step).
~3-4 weeks Siemens ADVIA Centaur HIV-1/O/2 EIA Anti HIV 1 and 2 EIA 4th Generation EIA test Enzyme Immunoassay which detects the presence of both protein p24 antigen and HIV antibodies.
Standard test protocol, as supplemental test following reactive 3rd Generation EIA test.
~2-3 weeks Abbot AxSym HIV Combo HIV 1 and 2 Ab/Ag EIA Western Blot Immunoblot which detects HIV antibodies directed against specific HIV proteins. Interpreted according to Canadian consensus guidelines.
Standard test protocol, as confirmatory test. Considered to be gold standard for confirmation of HIV infection.
~4-6 weeks, may take up to 8 weeks for a positive result.
BioRad Genetic Systems HIV-1 Western Blot Western Blot Individual RNA quantitative NAAT Detects viral RNA in plasma Standard test protocol, to resolve indeterminate results following 3rd Gen EIA and Western Blot <1-2 weeks Roche COBAS TaqMan HIV-1 RNA Test HIV 1 Quantitative NAT Pooled RNA Detects viral RNA in plasma of individuals who without detectable antibody (negative on antibody tests).
In evaluation/ research protocols.
to 12 days Roche COBAS TaqMan HIV-1 RNA Test Not applicable (a positive pool is confirmed by Individual RNA NAAT).
5.4 According to Mr.Mehta, indisputably, the PCR test could be termed as a much more effective test recognised by the medical science as it is the only method to detect virus of HIV during the window period. However, according to Mr.Mehta, the subject is a very complex subject and needs to be examined by experts in the field. Whether it is feasible to introduce PCR mandatorily all over the State or not, is a matter which requires examination from many aspects. Mr.Mehta submitted that the PCR test could be used as an additional test and the standard test i.e. Elisa, should not be replaced by PCR in toto.
III.
STANCE OF THE RESPONDENT NOS.1 AND 2- STATE GOVERNMENT :
6. Mr.Prakash K. Jani, the learned Government Pleader appearing for the Director, Gujarat State Council for Blood Transfusion and the Additional Chief Secretary, Health and Family Welfare Department, submitted that so far as the issue of collection of blood is concerned, the same is governed by the procedure as laid down in the Drugs and Cosmetics Act, 1940 (hereinafter referred to as 'the Act') and that licence to such blood banks is being issued by the Central Government under the said Act. According to Mr.Jani, the Act prescribes for Elisa/ rapid test and does not mandate PCR Test. Mr.Jani submitted that the Central Government may consider to amend the Act and introduce the PCR Test. According to Mr.Jani, the State authorities would not be in a position to make PCR Test compulsorily as it lacks jurisdiction in the field governed. Mr.Jani, however, made it clear that the State Government would follow the directives that would be issued by the Central Government in the entire country with regard to issue of collection of blood and blood transfusion under the Act. According to Mr.Jani, the State Government has gathered the following materials/ literature with regard to PCR test for better adjudication of the issue in question :
"Blood Transfusion Services (BTS) in Gujarat State is governed by the Drugs and Cosmetic Act. The blood banks licenced by Drug Controller General of India, are under different administrative controls i.e. Government, Voluntary, and Private/ Commercial.
The first line of defence in providing a safe blood supply and minimizing the risk of transfusion-transmitted infection is to collect blood from well-selected, voluntary non-remunerated blood donors from low-risk populations, particularly those who donate regularly. The prevalence of TTIs in voluntary non-remunerated blood donors is generally much lower than among family/ replacement donors. NACO/NBTC prescribed voluntary blood donor programmes which provide donor information and education and develop stringent criteria for blood donor selection and deferral to exclude prospective donors having high risk behaviour so as contacting HIV, Hepatitis B, Hepatitis C etc. DCGI/ NACO/ NBTC mandates the use of Assay system for testing donor's blood by the Blood banks in the India.
As per the WHO document any Assay systems should be systematically evaluated and selected before procurement and then validated in each blood bank before their introduction for routine use.
Polymerase Chain Reaction/Nucleic Acid Amplification Technology :
This technology goes under the generic name of nucleic acid amplification testing (NAT) and is based upon the direct amplification and detection of viral nucleic acids rather than antibody production by the immune system of the infected person.
These tests use a primer to rapidly make copies of the genetic material.
A reverse transcriptase PCR (RT-PCR) is used for HIV and other RNA viruses.
Transcription mediated amplification uses a slightly different molecular method than PCR but has the same basic principle.
Difference between ELISA and PCR/ NAT testing :
ELISA PCR/NAT
1. Can detect presence of antigen or antibody.
Can detect presence of RNA or DNA.
2. Window Period :
HIV 22 days - antibody detection (Antibody detection) 16 days - antigen detection (antigen & antibody both) Hepatitis B 38 days (3rd antibody) Hepatitis C 58 days (3rd antibody) Window Period :
HIV 11 days - minipool testing 6 days - individual donor testing Hepatitis B 25 days Hepatitis C 4.9 days (Novartis) 12 days (Roche)
3. Low Cost High Cost
4. Easy to perform Very complex to perform
5. Many companies are available in the market Only two manufacturers having with patented technology in the market.
6. Open system Closed system.
7. Time needed to release the component is less (approx.3.5 hours) Time need to release the component is more than 14 hours)
8. Can be done at individual blood bank level.
Difficult and very complicated to run at individual blood bank due to high investment and highly skilled manpower.
There are two companies working in the PCR/ NAT technology. They are M/S.Novartis Diagnostics and M/S. Roche Diagnostics having patented technology.
In the context of blood screening, appropriate evaluation is required in selecting the type of assay for each TTI, based on critical assay characteristics, such as sensitivity and specificity, false positive, false negative as well as cost and ease of use.
Important points to be addressed for PCR/NAT Testing :
Detection of infectious markers : HIV-1, HIV-2, HCV, HbsAG all together Sensitivity : Sensitivity is a statistical index of diagnostic accuracy. It has been defined as the ability of a test to identify correctly all those who have the disease that is "true positive". (Park's textbook of Preventive and social medicine 19th edition 2007 by K. Park pg 119-20) Specificity : Specificity is defined as the ability of a test to identify correctly all those who do not have the disease that is "true negative".
Sensitivity and specificity are inversely related. Sensitivity may be increased only at the expense of specificity and vice versa. An ideal screening test should be 100 percent sensitive and 100 percent specific. In practice, this seldom occurs. (Park's textbook of Preventive and social medicine 19th edition 2007 by K. Park pg 119-20) Predictive accuracy : In addition to sensitivity and specificity, the performance of a screening test is measured by its "predictive value" which reflects diagnostic power of the test. The predictive accuracy depends on sensitivity, specificity and disease prevalence in the population.
False Negative : The term false negative means that the patients who actually have the disease are told that they do not have the disease . This gives them a false reassurance. The lower the sensitivity, the larger will be false negatives.
False Positives : The term false positive means that the patients who do not have the disease are told that they have the disease. A screening test with high specificity will have few false positives and with low specificity will have high false positives.
Yield : Yield is amount of previously unrecognised disease that is diagnosed as a result of the screening effort. It depends on sensitivity, specificity of test and prevalence of disease.
Combination of tests : Two or more tests can be used to enhance the specificity or sensitivity of screening. (Park's textbook of Preventive and social medicine 19th edition 2007 by K. Park pg 119-20) Technical Analysis :
PCR/NAT testing is not a Gold standard test, as per NACO, which is a Central organization and National Apex body for HIV control programme under the Ministry of Health, Government of India.
As per requirements of PCR/NAT testing, the unit/ sample has to be checked by ELISA first and all non-reactive units are sent for testing by PCR/NAT technology.
Polymerase Chain Reaction/ Nucleic Acid Amplification Technology is based on presence of virus which can be detected earlier than antibodies but these tests have window period limitation which cannot be eliminated by PCR/NAT testing. Also, the commercially licensed available nucleic acid tests either detect HIV 1 with HBV and HCV, thus not detecting HIV 2 which is also required or other system instead of doing individual donor testing, do the pooling of donor samples before testing and detect HIV 1 and 2 with HCV but omit HBV serotype.
PCR/NAT test also give false positive result that is the person might not be suffering from HIV, even though test result may show him HIV positive.
The PCR/NAT is very complex technology, requiring technical expertise. The PCR/NAT takes eight to ten hours to complete the tests unlike serology test. This will affect the release of blood to the patients at time of need.
If the Central Government decides to go for PCR/NAT which is supplementary test over and above the existing test, all the blood banks will be under statutory obligation irrespective of high costing of PCR/NAT.
EQAS (External Quality Assurance Scheme) is not available for any of the company.
Out of 2 companies, none is complete in testing, i.e. none of the two companies can assure 100 percent accurate result for all mandatory test prescribed in D & C Act.
Studies with 20000 samples has not established any superiority of NAT testing (Bharatsinh et al) Sensitivity and specificity of PCR/NAT test yet to be determined in the Indian context.
There is no quantifiable cost effective advantage of implementing PCR/NAT testing as public health measures in the state.
Looking to the complexity of the NAT technology, issues regarding sensitivity and specificity of the PCR/NAT test and non-availability of large scale data about efficacy of test, NACO (a National programme for HIV) is the competent/ appropriate authority to decide HIV testing protocol in the light of availability of new technologies and its suitability for public healthcare system.
Any national programme is to be executed as per the guidelines of its apex organization in letter and spirit."
IV.
STANCE OF THE RESPONDENT NO.3-NACO :
7. Mr.Amit Panchal, the learned counsel appearing on behalf of the respondent No.3-Director, National AIDS Control Organization, Ministry of Health and Family Welfare, submitted that the PCR is not a mandatory test for screening of blood and blood products.
7.1 Mr.Panchal submitted that National AIDS Control Organisation only issues the National Blood Policy and the day to day functioning of the blood banks across the country lies with the State Government. The regulation and establishment of blood banks is under the Drug Controller General (India) and implementation of the same is with the State Government. Under Blood Safety Component of National AIDS Control Programme (NACP), the Government is committed to provide safe and adequate supply of blood and blood components in the country. Accordingly, selected licensed blood banks in the public and charitable sector are being supported by NACP, for providing certain equipments , manpower and consumables to ensure mandatory screening of blood units for Human immuno-deficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Syphilis and Malaria as prescribed under the provisions of the Drugs and Cosmetics Act . It is also submitted by the learned advocate that under the provisions of the Drugs and Cosmetics Act, 1940, all licensed Blood Banks must ensure freedom from HIV antibodies (AIDS) tests along with freedom from Hepatitis B surface antigen and Hepatitis C virus antibody , VDRL and malarial parasite before blood can be transfused.
7.2 Mr.Panchal relied upon the directions issued by the Honourable Supreme Court of India in Writ petition No.91 of 1992 filed by "Common Cause", a Society registered under the Society Act. The National Blood Transfusion Council (NBTC) was formed under NACO in 1996 with its Memorandum of Association and Rules and Regulations, whose one of its objectives being "development of National guidelines/ Standards for blood centre operations to be adopted by all Nodal Blood centers, while preparing their own standard operating procedures".
7.3 Mr.Panchal further submitted that according to these provisions, the reagents used for HIV must be ELISA or Rapid antibody tests for HIV 1 and 2. The learned advocate disagreed that standard testing is restricted to ELISA, as Rapid antibody tests are also permitted under the Drugs and Cosmetics Act, 1940. According to the National AIDS Prevention and Control policy, blood is screened for HIV using Strategy-I, which is done using a single antibody screening test. Any unit found to be reactive (i.e. antibodies to HIV are present) is required to be discarded by the concerned blood bank and only units negative for presence of antibodies to HIV are considered free of HIV and considered for transfusion subject to absence of the other four serological markers. In addition to HIV testing the blood units are also screened for Hepatitis B and C, Syphillis and Malaria. Only those blood units found to be free of all infectious markers i.e. HIV, HCV, HBV, Syphilis and Malaria are issued for transfusion to patients who require it. It is submitted that window period is a period from the time of infection till the appearance of antibodies in the body. However, Nucleic Acid Testing is based on presence of virus which can be detected earlier than antibodies but these tests have window period limitation which cannot be eliminated by NAT testing as stated by the writ-petitioner. Also, the commercially licensed available nucleic acid tests either detect HIV 1 with HBV and HCV, thus not detecting HIV 2 which is also required or other systems detect HIV 1and 2 with HCV but omit HBV. All five mandatory sero markers cannot be tested on any one system.
7.4 Mr.Panchal further submitted that Nucleic Acid Testing (NAT) is only an additional test over and above the antibody tests, as the gold standard for testing till date for HIV is antibody detection. The learned advocate also pointed out instances of reported cases which were seropositive (i.e. antibody detected by rapid/ELISA) but NAT negative samples. With reference to the newspaper article cited by the petitioner which refers to introduction of dried blood spot testing in infants and children <18 months of age is concerned, the learned advocate submitted that the babies under reference are those born to HIV positive mothers and that other children are not tested by DNA PCR testing under the National AIDS Control Programme (NACP). It was further submitted that this test is done on such children due to cross reacting antibodies of the mother which may exist in the baby limiting the use of antibody detection tests in the baby. The test performed in these cases is not to eliminate window period. It aims at detection of pro-viral DNA as a marker for HIV -1 infection as routine antibody tests may give false positive result due to presence of maternal antibody in baby's blood. It is submitted by the learned advocate that the PCR test detects the presence of proviral DNA in the baby, which can be detected from 6 weeks onwards and that the PCR test is not a gold standard but used in the absence of utility of antibody detection tests in these infants and children <18months born to HIV positive mothers. However, even if DNA is detected final confirmation is done by antibody tests at 18 months of age.
The learned advocate submitted that NAT testing is a technically complicated testing which offers very limited value on gaining of window period and cannot replace antibody testing which is the gold standard for diagnosis of HIV. It is also submitted that PCR testing for blood screening (for HIV/HCV) in blood banks is a type of NAT test offered by single vendor in the globe. The learned advocate also submitted that yield by NAT is 2 in 12,224 samples studied in an Indian study which were antibody negative and NAT positive. In this case it is also submitted that these could give positive result unless proved by seroconversion by donor follow up. However, in the same study there were 21 samples, which were antibody positive but missed by NAT or NAT negative clearly indicating utility of the above test. The strategy thus should focus on inducting healthy donors by appropriate donor counselling and deferral in blood banks.
7.5 Mr.Panchal also submitted that at the 23rd Governing body meeting of the NBTC held at NACO, New Delhi on 2nd Dec 2011, the issue of 'Introduction of Nucleic Acid Testing (NAT) in Blood Banks" was discussed as agenda item No. 3.5.1, wherein the members had then opined that NAT testing does reduce the window period, but it does not eliminate the same, as it is technologically intensive and requires capacity building and involvement of extra manpower. The value addition of this kind of testing over the existing protocol does not seem to be having any public health rationale at present.
7.6 Mr.Panchal submitted that with regard to the information sought for by this Honourable Court about the number of countries where ELISA tests are not followed and instead of that PCR tests or any other modern tests are being followed by the authorities for the purpose of transfusion of blood', NACO had sought the above information from Blood Transfusion Safety division of World Health Organisation (WHO). Based on the information available to WHO, no country in the world reports performing NAT (nucleic acid amplification technology) in place of ELISA testing for blood screening. However, over the last few years countries have introduced NAT (either mini-pool or individual testing), only after the quality and coverage of the blood screening at national level using serology techniques which have been well-established. It was thus, submitted that according to the available information no country in the world uses NAT testing as a substitute to antibody testing by ELISA or Rapid test for the purpose of Blood Transfusion.
7.7 Mr.
Panchal concluded by submitting that Polymerase Chain Reaction (PCR) is a principle of testing and not the name of a test. The principle of PCR testing is used in multiple kits manufactures for assisting in establishing diagnosis of various infections, e.g. viral, bacterial, parasitic etc. However, the above test is always used as a supplemental/add on test. It is not a 'gold standard' in diagnosing most of the infections and is not used alone, but is used in conjunction with other tests, clinical features etc. In case of HIV infection also , PCR is not a "gold standard" test. Multiplex PCR is a PCR test in which more than one infection can be detected in a given sample after running the test.
Thus, it was therefore, suggested that a focus on donor deferral through appropriate counselling will be far more effective for eliminating window period in the existing circumstance. The learned advocate also candidly accepted that there cannot be any restriction or impediment for any State/Blood Bank/Institution to undertake such tests over and above the prescribed standards as per Drugs & Cosmetics Act by using their own State resources.
V.
STANCE OF THE RESPONDENT NO.4-UNION OF INDIA:
8. Mr.Pankaj Champaneri, the learned Assistant Solicitor General of India, led emphasis on the Drugs and Cosmetics Rules, 1945 and submitted that the said Rules laid down requirement for collection, storage, processing and distribution of whole human blood components by blood banks and for manufacture of blood products.
8.1 According to Mr.Champaneri, the Elisa test is time tested, cost effective, consumes less time to give results, has a potential to test large number of samples in a single cycle, requires minimum expertise and there are large number of samples manufacturers of ELISA kit.
8.2 According to Mr.Champaneri, the PCR Test is a very complex technology and at the same time, very expensive. It demands expertise handling condition and meticulous technique. He submitted that there are a few companies manufacturing PCR kits and at times, may give false positive result. It takes around 16 hours to complete the test unlike ELISA Test which takes 1.5 hours to give the necessary result. According to Mr.Champaneri, such time consuming method may sometime hamper timely transfusion of blood to needy patients.
8.3 Mr.Champaneri submitted that window period is the period in which newly infected people have not yet produced enough HIV antibodies to be detected. He submitted that the writ- petitioner is not right in asserting that window period is three months for ELISA and PCR method totally eliminates the window period. He further submitted that under ELISA method, the window period is 16-22 days (about 3 weeks) and under PCR method, the window period is 6-11 days. He submitted that even by adopting the PCR method, the window period cannot be eliminated which is being contended by the writ-petitioner.
9. During the course of hearing of this matter, we also noticed that the Union of India relied upon the view of the National Institute of Biologicals (NIB) for testing the biologicals in support of their view that PCR method is not advisable. We, therefore, though fit to ask the National Institute of Biologicals to express their views on the subject. To our benefit, the National Institute of Biologicals have filed an affidavit explaining as under :
"2. It is most respectfully submitted that safe supply of blood is of paramount importance in all the countries. At present, there are about 2535 licensed Blood Banks in India which are regulated under the Drugs and Cosmetic Act, 1940 to provide safe blood by minimizing the risk of transmission of Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) etc. It is submitted that National AIDS Control Organization (NACO) deals with research, prevention & control of HIV & Blood safety in India. Screening (examination) of blood is mandatory for these viruses as per the Drugs and Cosmetics Rules, 1945 and as per the guidelines as issued by the World Health Organization (WHO). The screening of blood is done by following main assays :
Screening of Blood by Enzyme Linked Immuno Sorbent Assay (ELISA)/ Rapid Kit :
WHO has recommended use of various ELISA/ Rapid kits for screening of blood. Earlier, 1st and 2nd generation ELISA kits were used for screening of blood. These kits were able to detect HIV antibodies after 55 and 45 days of infection respectively. It is submitted that mostly use of these kits were discontinued mainly due to their lesser sensitivity and specificity. It is further submitted that with the rapid progress in science, better 3rd generation ELISA (sandwich based) kits were developed and introduced in the market about a decade ago. Since their development and introduction in the market these kits are still in use. The advantage with this kit is that they are able to detect HIV antibodies after 22 days of infection. It is further submitted that recently, the more advanced 4th generation ELISA Kits have been developed are being introduced in the market. It is respectfully submitted that they are more advanced as they detect P24 antigen (protein part of the virus) as well as HIV antibodies after 17 and 22 days of infection respectively. They thus further reduce the window period of the infection and helping in the early detection of the infection. It is respectfully submitted that these kits are economical, frequently used in blood banks and have other advantages as well.
Screening of blood by PCR testing :
The screening of blood by PCR testing helps in detection of viral RNA (genetic material of HIV). It has been in use in many countries as a complement to the traditional ELISA testing to screen whole blood, serum and plasma samples. There are various types of PCR Techniques which are meant for screening of blood, qualitative and quantitative analyses of RNA in the blood samples. The window period for detecting the infection of HIV through the PCR testing is 11 days, thereby, further increasing the safety of the blood.
3. It is submitted that around the world, more than 53 out of 92 million units of blood collected per annum are screed with both PCR & ELISA in the developed countries like USA and European countries as well as in developing countries like Thailand, Malaysia, Indonesia, Egypt, Mexico, Korea, etc. It is submitted that a few blood banks of the Government Sector (AIIMS) as well as some blood banks operated and managed by Private (Apollo Hospital, New Delhi) & NGOs (Lions Club) have already started using PCR technique for screening of blood for viral infections. PCR method is expensive and its kits are costly but it can be made cost-effective in a phased manner by making centralized facility and by using multiplex PCR meaning by detecting all the three viruses together in a mini pool of 16 to 24 blood units as being practiced in some of the above mentioned countries. It is further submitted that PCR technique has been proving useful recently in medico-legal cases particularly when only seronegative tested blood transmitted infection in the patient.
4. It is submitted that The World Health Organization (WHO) in its manual 2010 states that "Screening of Transfusion Transmitted Infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recepients is a critical part of the process of ensuring that transfusions are as safe as possible." As NAT/PCR is too expensive in future a significant TTI reduction which will help in ensuring that their blood supplies meet international safety standards.
5. It is respectfully submitted that overall, HIV antibody screening by ELISA/ Rapid Kit remains indispensable for ensuring rival safety of blood despite PCR implementation because these are not equivalent rather complementary to each other.
It is evident from the above that PCR has been found to enhance the safety of blood but its implementation in India may be considered by NACO and Government in a phased manner in the forthcoming few years."
VI.
ANALYSIS:
10. Taking into consideration the complex nature of the issue with which we are dealing, we have to be mindful of the principle that judicial review of a policy evolved by the Government is limited. On matters affecting policy and requiring technical expertise, the court would leave the matter for decision of those who are qualified to address the issues.
11. In Balco Employees Union (Regd.) v. Union of India and others, reported in (2002) 2 SCC 333, the Supreme Court observed in paragraph 46 as under :
"46.
It is evident from the above that it is neither within the domain of the Courts nor the scope of the judicial review to embark upon an enquiry as to whether a particular public policy is wise or whether better public policy can be evolved. Nor are our Courts inclined to strike down a policy at the behest of a petitioner merely because it has been urged that a different policy would have been fairer or wiser or more scientific or more logical."
12. The Supreme Court further proceeded to observe that in examining a question of the nature where a policy was evolved by the Government, judicial review thereof is limited. On matters affecting policy and requiring technical expertise, the Court should leave the matter to the experts who are qualified to redress the issues. Unless the policy or action is inconsistent with the Constitution and the laws or arbitrary or irrational or abuse of powers, the Court will not interfere with such matters.
13. In TATA Iron and Steel Co. Ltd. v. Union of India and another, reported in (1996) 9 SCC 709, the Supreme Court passed the following observations in paragraph 68 :
"68. At this juncture, we think it fit. to make a few observations about our general approach to the entire case. This is a case of the type where legal issues are intertwined with those involving determination of policy and a plethora of technical issues; In such a situation, courts of law have to be very wary and must exercise their jurisdiction with circumspection for they must not transgress into the realm of policy making, unless the policy is inconsistent with the Constitution and the laws. In the present matter, in its impugned judgment, the High Court had directed the Central Government to set a Committee to analyse the entire gamut of issues thrown up by the present controversy. The Central Government had consequently constituted a Committee comprising high level functionaries drawn from various Governmental/institutional agencies who were equipped to deal with the entire range of technical and long-term considerations involved. This Committee, in reaching its decision, consulted a number of policy documents and approached the issue from a holistic perspective. We have sought to give our opinion on the legal issues that arise for our consideration. From the scheme of the Act it is clear that the Central Government is vested with discretion to determine the policy regarding the grant or renewal of leases. On matters affecting policy and those that require technical expertise, we have shown deference to, and followed the recommendations of, the Committee which is more qualified to address these issues."
14. In State of U.P. and others v. Ranusagar Power Co. and others, reported in (1988) 4 SCC 59, the Supreme Court passed the following observations in paragraph 76 :
"76. Shri Trivedi, learned Additional Advocate-General, State of Uttar Pradesh drew our attention to the case of Panama Canal Company v. Grace Line, 356 U.S. 309 2 Lawyers' Edn. 788, where at page 793 of the report while dealing with the facts of that case Justice Douglas observed that, as it was seen in that case, the conflict raged over questions that at heart involved problems of statutory construction and cost accounting: whether an operating deficit in the auxiliary or supporting activities was a legitimate cost in maintaining and operating the Canal for purpose of the toll formula. These are matters on which experts might disagree; these involve nice issues of judgment and choice, which required the exercise of informed discretion. In those circumstances Justice Douglas observed that the case was, therefore, quite unlike the situation where a statute created a duty to act and an equity court was asked to compel the agency to take the prescribed action. What was emphasised was that the matter should be far less cloudy, much more clear for courts to intrude. It is also in this connection necessary that if technical considerations are involved the Court feels shy to interfere. Reliance was placed on the observations of this Court in Vincent Panikurlangara v. Union of India and others, [1987] 2 S.C.C. 165. There the writ petition involved the claim for withdrawal of 7000 fixed dose combinations and withdrawal of licences of manufacturers engaged in manufacture of about 30 drugs which have been licensed by the Drugs Control Authorities; the issues that fell for consideration are not only relating to technical and specialised matters relating to therapeutic value, justification and harmful side effects of drugs but also involved examination of the correctness of action taken by respondents 1 and 2 therein on the basis of advice; the matter also involved the interest of manufacturers and traders of drugs as also the interest of patients who require drugs for their treatment. This Court reiterated that in view of the magnitude, complexity and technical nature of the enquiry involved in the matter as also the far-reaching implications of the total ban of certain medicines for which the petitioner had prayed, a judicial proceeding of the nature initiated was not an appropriate one for determination of such matters. The technical aspects which arose for consideration in a matter of that type could not be effectively handled by a court. This Court also reiterated that similarly the question of policy which was involved in the matter was also one for the Union Government-keeping the best interest of citizens in view-to decide. No final say in regard to such aspects came under the purview of the court."
15. Bearing the aforesaid principle of law in mind, our final conclusion in the matter is as under :
15.1 As held by the Supreme Court in the case of Common Cause v. Union of India, reported in (1996) 1 SCC 753, the blood is an essential component of the body which provides sustenance to life. There can be no greater service to the humanity than to offer one's blood to save the life of other fellow human-beings. At the same time blood, instead of saving life, cannot lead to death of the person to whom the blood is given if the blood is contaminated. As a result of developments in medical science it is possible to pre-serve and store blood after it has been collected so that it can be available in the case of need. There are blood banks which undertake the task of collecting, testing and storage the whole blood and its components and make the same available when needed, In view of the dangers inherent in supply of contaminated blood it must be ensured that the blood that is available with the blood banks for use is healthy and free from infection.
15.2 We have no doubt in our mind after going through the materials on record that PCR Test is a superior test compared to ELISA Test. The importance of PCR Test lies in its capacity to detect the virus during the Window Period. According to the study of the medical science, the length of time following the infection of an individual to develop detectable antibodies is about three months after the infection, this is called the "Window Period".
Take a case where the ELISA Test fails to detect HIV virus during the Window Period and on the strength of such negative report if such blood containing HIV virus is transfused to a person, he would easily get affected by the HIV virus. It is at that stage, perhaps, by way of abundant caution that the PCR Test could also be undertaken to rule out the presence of the HIV virus in the blood during the window period.
15.3 The materials on record also suggest that testing kits, so far as ELISA Test is concerned, are easily available as there are many manufacturers in the market, whereas the testing kits for PCR Test are not being manufactured on large scale and the cost factor is also compared to the ELISA Test much higher. However, we would like to make one aspect very clear that when we are dealing with the subject of life of a citizen, the cost should not be a factor so far as the Government is concerned. It is the duty of the Government to protect the life of its citizens and it would not lie in the mouth of any Government to say that because of cost factor, the PCR Test is to be ruled out. Life is priceless. However, we have also noticed that the PCR Test takes around 16 hours to give necessary results, whereas the ELISA Test takes around 1.5 hours. In a given case, when there is an urgent need of blood transfusion, then the time factor would also play a crucial role. It appears to us that there are positive aspects as well as negative aspects of the PCR Test and as pointed out by Mr.Jani, the learned Government Pleader, the Act also prescribes the ELISA Test.
15.4 This is a matter of policy, and therefore, this Court sitting in a public interest jurisdiction should not issue directions to the State Government or the Union of India to frame a particular legislation, e.g. introducing the PCR Test.
15.5 We are, therefore, of the view that this issue needs to be looked into very extensively by a body of experts in the field. When the Central Government has already declared way back in the year 2006, introduction of DNA Polymerase Chain Reaction (PCR) Test, a dry blood sampling method of testing for paediatrics AIDS, then in such circumstances, the Central Government, after seeking opinion from a body of experts, should also consider implementation and execution of the same in its true perspective.
15.6 We, therefore, direct the respondent No.3-Ministry of Health and Family Welfare Department, Government of India, to constitute a body of experts in the subject to examine as to what extent the PCR Test could be made mandatory at all licensed blood banks across the country. We direct the respondent-Union of India to constitute such committee within a period of two months from today. The Committee constituted shall consider the issues raised in this writ-application and place its report before this Court within a period of three months thereafter.
Let the matter appear in the First Week of May, 2013, to consider the report of the Committee of experts.
(Bhaskar Bhattacharya, Chief Justice) (J.B.
Pardiwala, J.) Aakar