In the High Court of Judicature at Madras
(Special Original Jurisdiction)
W.P.No. of 2020
President, Desiya Makkal Sakthi Katchi
No.21/11, Venkatraman Street,
Chennai-600 079 ….Petitioner
- The Secretary,
Ministry of Health and Family Welfare,
Government of India,
‘A’ Wing, Nirman Bhavan,
New Delhi, DL – 110001
- The Secretary
Ministry of Health and Family Welfare
Government of Tamil Nadu
Chennai, TN – 600009
- Director General,
Indian Council of Medical Research,
V. Ramalingaswami Bhawan,
New Delhi, DL – 110029.
ICMR – National Institute of Virology
20/A, Dr.Ambedkar Road
Pune, MH – 411001 ….Respondents
AFFIDAVIT OF M.L.RAVI
I, M.L.RAVI, Son of M.Lakshmipathy, Hindu, aged about 54 years, residing at No.21/11, Venkatrama Street, Chennai- 600 079, do hereby solemnly affirm and sincerely state as follows:-
- I submit that I am the President of Desiya Makkal Sakthi Katchi, a registered Political Party, registered with Election Commission of India, a Practicing Advocate, a Social Activist, Charter president of Lions Club of Chennai Mint. I have contested in the Elections held for Lok Sabha, as Candidate of North Madras.
- I state that I am the Petitioner herein and as such I am well acquainted with the facts of the case. I submit that I am filing this writ petition as Public Interest Litigation out of my own funds. My PAN No. is AAFPR1527G. My Income per annum is Rs.2,50,000/-. I have no personal interest in this petition. I am ready to accept the order of the court and cost if any order to be paid. I am also ready to abide by any other condition that may be imposed by this Hon’ble Court. I pray that the contents of the typed set may be read as part and parcel of this affidavit. I may be permitted to submit additional affidavit, at later stage after the respondent submit their replies.
- I submit that I have filed various Public Interest Litigation petitions in this Hon’ble Court. Our main objectives of upholding the Constitution and its values, Social Justice with equal opportunities to all and a corrupt free and transparent administration and Good Governance. We have been actively taking up the cause of the people of this country in various forms, I have planted One lakh Trees.
- I submit that with China first reporting of cases of pneumonia from of unknown etiology (unknown source) to WHO on 31-12-2019 and detection of first cases in neighbouring Thailand on 13-01-2020, Japan on 15-01-2020, South Korea on 20-01-2020 and India on 30-01-2020 and to almost all countries thereafter, the WHO has declared it to be an international pandemic. The novel Corona virus (COVID-19) is yet without any drug invented for treatment or vaccination and in the circumstances is treated by increasing immunity through certain drugs in existence and traditional knowledge.
- I submit that the Government of India, on 24th March 2020, announced lockdown throughout country due to COVID-19 epidemic, based on the Notification issued by the World Health Organisation. An Order No. 40-3/2020-DM-I(A) was issued by the Home Ministry, in this regard, for a period of 21 days upto 14th April 2020 and which was later extended till 3rd May 2020.
- I submit that with many “Asymptomatic” cases reported in India (cases where there are no symptoms of the virus on the carrier for upto 21 days and yet the person continues to infect others) the spread of virus by such Asymptomatic carriers will continue undetected and be the source of infection for a multitude of others. The spread of COVID-19 can be controlled only by extensive testing followed by treatment to the infected. And therefore, Corona virus will continue to spread inspite of lockdown and social distancing announced and implemented. And for this purpose of increased testing, the Government of India and States have taken measures procure Rapid Test Kits for faster diagnosis and extensive testing.
- I submit that the Indian Council of Medical Research the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. The National of Virology, Pune is an Institute under ICMR and the premier Institute for intensive training and research in virology in India.
- I submit that at present Polymerise Chain Reaction (PCR) and Antibody testing are the 2 dominant ways that global healthcare systems are testing citizens for COVID-19 while researchers are looking into alternate ways. The PCR Test uses nasopharyngeal swab samples to directly detect the presence of an antigen. By detecting viral RNA, which will be present in the body before antibodies form or symptoms of the disease are present, the tests can tell whether or not someone has the virus very early on. However, PCR Tests are time consuming and very labour intensive, with several stages at which errors may occur between sampling and analysis. The Antibody Test usually uses blood samples to measure antibody presence in the blood rather than very small amount of Corona virus in the blood and Test results are usually available within hours.
- I further submit that with the very high global demand for Testing Kits and specifically Rapid Testing Kits for diagnosis of COVID-19, there have been reported instances of defective or ineffective Rapid Test Kits of Chinese origin been sold to those in desperate need for some form of testing in their pursuit to stop spread of COVID-19. Spain and Turkey have been victims to such sale of defective / ineffective Rapid Test Kits as gathered from news reports on 26-03-2020.
- I submit that with the extensive testing that India needs to effectively control the rapid spread of COVID-19, the faster test result yielding Rapid Test Kits that use Antibody Testing was possibly considered better suited by the Indian Government and Governments of the Indian States while deciding to order for Rapid test Kits.
- I submit that ICMR, though ICMR–National institute of Virology, Pune, is known to have tested 23 such Antibody based Rapid Test Kits made by different manufacturers and has found 18 of such Rapid Test Kits to be satisfactory of which 9 of them were from / made by Indian Companies. Further to this, on 16-04-2020 ICMR had issued guidance for usage of Rapid Antibody Kits for testing COVID-19. ICMR’s Guidance found the rapid test Kits of those 18 Companies to be satisfactory and also permitted CE-IVD Certified Rapid test Kits for direct usage (without testing at NIV, Pune) after due approval from Drugs Controller General of India (“DCGI”).
- I submit that Government of India has ordered for 37 lakhs Antibody Rapid Test Kits and 33 Lakhs RT-PCR Kits. Antibody Rapid Test Kits of 3 lakhs quantity has been purchased from Wondfo Biotech, Guangzhou, China. These Rapid Test Kits were distributed to various States including Tamil Nadu. Tamil Nadu had independently placed order for 1.25 lakhs pieces and already received 24,000 pieces of Rapid Test Kits made by Wondfo Biotech through Shan Biotech, Chennai. Government of Andhra Pradesh has independently purchased Rapid Test Kits from
- I submit that Government of India released a Purchase Order for 5 Lakh pieces of Wondfo Biotech Company made Antibody based Rapid Test Kits through Aark Pharmaceuticals, New Delhi.
- I submit that ICMR Released Guidance for purchase of Rapid Test Kits was based on (i) satisfaction from testing done at National Institute of Virology, Pune and also based on (ii) Rapid Test Kits of those manufactured with CE–IVD Certification of European Economic Union as available, as per ICMR, on https://www.finddx.org/covid-19/pipeline/
- I submit that from the Rapid Test Kits of Wondfo Biotech is not evidently seen to have been tested at the National Institute of Virology, Pune as seen from the absence of the products Batch Number in the Guidance issued by ICMR on 16-04-2020. Nor is the Rapid Test Kit (for COVID-19 Antibody Testing) of Wondfo Biotech evidently seen to have the CE–IVD Certification of the European Economic Union to be considered by ICMR as fit for use.
- I submit that the acts of the Union of India and the States in ordering millions of Testing Kits
(a) Ignoring the prevalence of defective Rapid Test Kits supplied by Chinese companies from as early as 26-03-2020
(b) Without applying the guidance of ICMR for using only such Rapid test Kits that have been found to be satisfactory after testing at NIV, Pune
(c) Without applying the guidance of ICMR for using only such Rapid test Kits that have CE–IVD Certification of the European Economic Union when not tested at NIV, Pune
is a clear case of arbitrary exercise of power.
- I further submit that after beginning to use the Rapid Test Kits that have arrived into India from Chinese manufacturers, test results have been found to be erroneous with both false negatives and false positives thereby making the exercise of test with Rapid Test Kits a futile one. Some States like Punjab have returned these Rapid Test Kits back to ICMR.
- I submit that ICMR ON 21.04.2020 ask the States and other users to halt testing for COVD 19 using the Rapid Test Kits imported without disclosing that the imported Rapid Test Kits do not conform to the standards declared by ICMR as it shows erroneous results like a positive patient tested by RT-PCR showing Negative in Antibody Rapid Test Kit testing.
- I submit that Details of Total Rapid Test Kits ordered from one or more suppliers have not been made available in the public domain. News reports indicate that India has ordered 3 Million Rapid Test Kits in total at this time. With ICMR finding Rapid Test Kits manufactured by 18 different manufacturers, including 9 from India, to be satisfactory, the basis of ordering 5 Lakh Kits from only a select supplier like Wondfo Biotech that did not satisfy NIV, Pune’s testing or have a CE–IVD Certification is with total Non-application of mind.
- I submit that Order of the 6.5 Lakh Rapid Test Kits received by India on 17-04-2020 included 3 Lakh from Wondfo Biotech. It is unclear as to how much more of Rapid Test Kits has been ordered from Wondfo Biotech or such similar defective and non-certified manufacturers apart from the Purchase Order dated 27-03-2020 for 5 Lakh Test Kit Units.
- I submit that it is necessary to direct the Ministry of Health to implement testing for COVID-19 using only such Rapid Test Kits that are tested to be satisfactory by NIV, Pune or CE-IVD Certified. Else, it will result in mass mismanagement of a pandemic of epic proportion leaving a catastrophic effect on public health and economy and pushing millions into poverty, deprivation and deaths as evidenced in other parts of the globe.
- I submit that while swift action in procuring Test Kits, Private Protection Equipment (“PPE”), Medicines, Active Pharmaceutical ingredients, etc. necessitated at this juncture to prevent tragic outcomes from spread of COVID-19 as evidenced in other countries like USA, Spain, Italy, etc. procedural violations like those with Transparency in Tender Act, and other legislation and may be justified for the purpose of public good intended through public health sought to be achieved. However, the arbitrary exercise of power with non-application of mind that can only result in aggravating the spread of COVID-19 through faulty testing with the defective Rapid Test Kits is a direct affront to the Right to life guaranteed under the Constitution.
- I further submit that ineffective testing from such defective Rapid Test Kits will only result in tragic loss of lives in the numbers as seen USA. Spain and Italy or even more and it is very much in the interest of the public that such a tragedy is prevented by swift judicial intervention and remedy from the Executive’s arbitrary exercise of power that has resulted in a compromise in the health and safety of lives of citizens through sheer non-application of mind. And, this Writ Petition has been filed when there is no other effective or alternate remedy given the gravity of the situation, except to invoke Article 226. It is further prayed that this Hon’ble Court may be please to pass an interim order to Stay the Purchase Orders issued by the 1st and 2nd Respondents for purchase of Rapid Test Kits from manufacturers whose Rapid Test Kits have shown wrong (variance) results on the patients tested pending disposal of this and thus render justice. I therefore pray that this Hon’ble Court may be pleased to Issue writ of MANDAMUS or any other order or orders or direction in the nature of writ, to direct the 1st and 2nd Respondents to fully implement testing for COVID-19 in their Healthcare System using only such Rapid Test Kits that have been tested to be satisfactory by National Institute of Virology, Pune OR using such Rapid Test Kits that have been CE–IVD Certified by European Economic Union and pass such further and/or other orders as this Hon’ble Court may deem fit and proper and thus render justice.
Solemnly affirm at Chennai on this
the 24th day of April 2020 and BEFORE ME,
Signed his name in my presence.