The Madras High Court is set to consider a PIL seeking an injunction against the Centre and the state of Tamil Nadu from procuring and using in their Healthcare Systems such In-Vitro Diagnostic Test Kits for COVID-19 (RT-PCR Test Kits as well as Antibody Rapid Test Kits) that do not have the approval of the Regulator- the Drug Controller General of India.
Petitioner M. L. Ravi, President of Desiya Makkal Sakthi Katchi, a registered Political Party, has submitted that the RT-PCR Test Kits being accurate only 70℅ of the time and giving False Negative in the rest will mean that there will be undetected spread by Carriers who tested Negative and this is because these kits are in use without being DCGI-approved.
In view of the public interest involved, and after hearing the arguments, the Court, at the previous occasion, was inclined to implead DGCA as necessary party to contest the writ petition.
"Based on the on-going approvals by ICMR that GoI, through National Institute of Cancer Prevention and Research ("NICPR"), issued a Purchase Order ("PO") to Aark Pharmaceuticals, New Delhi ("Aark Pharma"), on 28-03-2020, for procuring 5,00,000 Antibody Rapid Test Kits manufactured by Wondfo Biotech, Guangzhou, China ("Wondfo")...Newspaper reports suggest that GoI has further ordered about 3 million Rapid Test Kits and 3 million RT-PCR Test Kits and it is not known if those Kits ordered are ones approved (with grant of Licence) by the Regulator, DCGI. Neither the process for those procurement nor the vendor for supply has been made available to the public and shrouded in secrecy", it is asserted.
However, it is argued that from data available in the public domain, India's DCGI has approved only the COVID-19 Test Kits (2 – PCR and 2 – Rapid Test Kits) of 4 manufacturers.
The plea avers 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 through such Asymptomatic carriers will continue undetected and be the source of infection for a multitude of others. Further, erroneous and ineffective testing using defective test kits and such test kits that have not been approved for quality by the Regulator DCGI will not have properly detected the virus affected persons to be kept in isolation for COVID-19 treatment and thus further add to the spread of COVID-19 by un-detected carriers.
"SARS Cov-2 spread will continue despite the implementation of lockdown due to
a) ineffective and erroneous testing done with defective test kits
or test kits not approved for quality by DCGI
b) Asymptomatic nature of SARS Cov-2 for up to 21 days and therefore the spread of COVID-19 can be controlled only by extensive testing and effective testing followed by treatment to the infected", it is urged.
The petition avers that the nations that have been relatively unaffected by COVID-19 or those nations that had better controlled COVID-19 spread are those nations that had done extensive testing and effective testing. Countries like South Africa, and others with an even higher population density like Taiwan and Hong Kong have managed to control the spread of COVID-19 without a lockdown with effective testing and extensive testing, followed by available treatment, further substantiating the fact that effective testing and extensive testing alone is the best step forward.
Besides, between countries that have done "extensive" testing with closely similar rates of testing (persons tested per million population) like South Korea and USA, the difference has been "effective" testing. "A recent research report on test kits being used in the US has found most Test Kits to be without US-FDA approval and confirmed that Test Kits with even a 3% false result is not interpretable and a 13% false result is useless", it is pointed out.
It is stated that under the Drugs and Cosmetics Act, 1945, per Sec.3(b)(ii), a "Drug" includes Devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings. And, the COVID-19 Diagnosis Test Kits that use nasal and throat swab samples extracted from human bodies (RT-PCR Test Kits) and Test Kits that use blood samples extracted from human bodies (Antibody Rapid Test Kits) are "In-Vitro" Diagnostic ("IVD") Medical Devices and come within the definition of "Drug".
"Under the DC Rules, in "Part X A" that relates Rules on Import or Manufacture of New Drugs for Clinical Trials or Marketing, Rule 122-A prescribes that No new Drug (including In-Vitro Diagnostics by implication) shall be "Imported" except under and in accordance with the permission granted by the Licensing Authority appointed under Rule 21(b). And, Rule 122-B prescribes that No new Drug (including In-Vitro Diagnostics by implication) shall be "Manufactured" for Sale unless it is approved by the Licensing Authority appointed under Rule 21(b)", it is advanced.
The petitioner submits that DGCI is the Authority appointed by the Central Government to perform the duties of the Licensing Authority per Rule 21(b). And a total of 7 Labs notified to be Central Drugs Laboratory, for the purpose of testing and analysis of Drugs amongst other purposes, that come under the Central
Drugs Standard Control Organization ("CDSCO") as well as other statutorily required Drugs Consultative Committee ("DCC") and Drugs Technical Advisory Board ("DTAB") are all headed by DCGI.
Further, Rule 69(2)(c) provides for an Application for a Licence to "Manufacture" In-Vitro Diagnostics and Rule 81(1) provides for the grant of the Licence thereto. Likewise, Rule 24 provides for an Application for a Licence to "Import" Drugs (including In-Vitro Diagnostics by implication) and Rule 27 provides for the grant of the Licence thereto.
Moreover, the conditions for Licence to "Import" Drugs prescribed under Rule 26 for grant of Import Licence under Rule 27 and the conditions for Licence to "Manufacture" Drugs prescribed under Rule 78 and Schedule 'F' or Schedule 'F(1)' for grant of Manufacturing Licence under Rule 81(1) require among other conditions the adherence to standards of quality. The standards of quality are specified in Rule 125A and "Schedule R-I". And the Quality Management System to be followed in case of manufacture of Medical Devices and In-Vitro Diagnostics are specified in "Schedule M – III".
It is brought to the Court's attention that the Indian Council of Medical Research ("ICMR") has taken upon itself the role of Approving COVID-19 Test Kits for use in Healthcare Systems even without those Test Kits being approved for Quality Standard by DCGI. This has resulted in GoI and GoTN and other states, through the different arms/agencies of the Government, procuring numerous COVID-19 Test Kits that have not been approved by DCGI and which has eventually turned out to be defective Test Kits providing erroneous test results (False Positives and False Negatives for infection of SARS Cov-2 virus) that will now add to the "un-detected" spread of COVID-19.
Click Here To Download Order
Click Here To Download Affidavit