NEW DELHI: A total of 6,05,65,728 samples were tested for COVID-19 in India between March 23 and September 16, and the testing capacity increased manifold with over 1,700 laboratories conducting these tests as against one in January, Union Minister Ashwini Choubey told Parliament on Friday.
In a written reply to a question in Lok Sabha, the Union minister of state for health said an effective COVID-19 vaccine is likely to be available by the first quarter of 2021 if the advanced trials of vaccines succeed.
A total of 6,05,65,728 samples had been tested across India for detection of COVID-19 from March 23 to September 16, Choubey said in a written reply to another question.
Tests (4,43,40,875) had been done on approximately 3.23 per cent of the total projected population of 1,37,23,60,351 till September 1, he said.
Recognising the importance of early detection of cases through testing, capacity for COVID-19 testing in the country has been enhanced manifold, Choubey said.
From a single laboratory equipped to undertake testing for COVID-19 in January, presently (as on September 16) 1,751 laboratories are conducting testing, he said.
Laboratories have been established in difficult terrains like Ladakh, Sikkim, Arunachal Pradesh, Nagaland as well as other northeastern states, Lakshadweep, and Andaman and Nicobar Islands, he informed.
"Currently, the testing is about 1 million tests a day (which translates to 720 tests per million population per day), much higher than that stipulated by WHO which is 140 tests per million population per day," the minister said.
Besides the gold standard Real-Time Polymerase Chain Reaction (RT-PCR), testing is being done through Truenat and CBNAAT platforms.
In addition, rapid Point-of-Care (PoC) Antigen detection tests are being utilised which have a quick turnaround time.
On the accuracy of the RT-PCR testing kits in detecting the SARS-COV-2 viral infection, Choubey said the kits for COVID-19 testing as per ICMR acceptance criteria have a specificity of 99 per cent or more.
"This means out of 100 tests conducted on negative samples, only one will yield a false positive," he said.
For tests like POC, a specificity of 99 per cent or more is desired.
For quantitative IgG antibodies and CLIA, a specificity of 95 per cent is desired, he said.
In a written reply to another question on the time by when a COVID-19 vaccine is likely to be commercially launched, Choubey said, "If the advanced clinical trials of Covid vaccine succeed, then an effective Covid vaccine is likely to be available by the end of the first quarter of 2021."
More than 30 vaccine candidates have been supported which are in different stages of development, three candidates are in advanced stages of Phase I/II/III trials and more than four are in the advanced pre-clinical development stage, he said.
A National Expert Group on Vaccine Administration for COVID-19 has been constituted on August 7, he said.
The minister said 13 clinical trials of repurposed drugs have been undertaken to build a portfolio of therapeutic options for COVID-19 patients.
On whether the government has considered the request by states and union territories to increase funding through the National Disaster Response Fund, Choubey said no such request has been received.
Expenditure related to COVID-19 measures, for quarantine, sample collection and screening, procurement of essential equipment/laboratories, relief measures, etc.
is allowed under the State Disaster Response Fund only, he said.
Choubey said states are being supported in terms of supply of logistics.
A total of 1.41 crore PPE kits, 3.44 crore N-95 masks, 10.84 crore tablets of hydroxychloroquine, 30,663 ventilators and 1,02,400 oxygen cylinders have been supplied to states, UTs and central government hospitals till September 14, he said.
A total of Rs 4,256.79 crore of grants were provided under the COVID-19 Emergency Response and Health System Preparedness package, the minister informed.
Besides, states and UTs have been supported for technical guidance in terms of guidelines, advisories, containment plans, Standard Operating Procedures, etc, he said.
Choubey said the Union of India has taken a series of actions to prevent, control and mitigate the impact of the pandemic and India followed a "whole of government and whole of society approach".
Public health actions were taken in a pre-emptive, pro-active, graded manner based on the evolving scenario.
A number of travel advisories were issued restricting the inflow of international travelers.
Commercial flights were suspended on March 23, he said.
Till then, a total of 14,154 flights with 15,24,266 passengers had been screened at airports.
Screening was also done at 12 major and 65 minor ports and land border crossings, he added.
In the initial days of the pandemic, India evacuated a large number of stranded passengers from then COVID affected countries like China, Italy, Iran, Japan and Malaysia.
In the un-lockdown phase, a total of 13,18,891 passengers have been brought back till September 14 and followed up, Choubey said.
The Integrated Disease Surveillance Programme (IDSP) is conducting contact tracing through community surveillance, he said.
In the earlier part of the pandemic, this was done for travel-related cases and subsequently for cases being reported from community as a part of the containment strategy.
As on September 14, a total of about 40 lakh people have been kept under surveillance, the minister said.
Till September 15, a total of 15,360 COVID treatment facilities with 13,20,881 dedicated isolation beds without oxygen support have been created, he said.
There are a total of 2,32,516 isolation beds with oxygen support and 63,194 ICU beds, including 32,409 ventilator beds, he informed.
Choubey said a dedicated helpline (1075) has been started to guide the community at large which is being used by the citizens very effectively and on a regular basis.
Government cancelled ICMR's purchase orders from China for COVID-19 test kits: MoS Health Choubey
The Indian Council of Medical Research (ICMR) had placed purchase orders for COVID-19 antibody test kits to Indian firms which were cancelled subsequently with no payment made to any Chinese company, the Lok Sabha was told on Friday.
In a written reply to a question, Minister of State for Health Ashwini Choubey said the ICMR has not imported huge quantities of antibody test kits from China.
Narrating the sequence of incidents which led the government to withdraw the faulty COVID-19 antibody test kits from China and the grounds on which the import orders were cancelled, Choubey said antibody kits of M/s Aark Pharmaceuticals (Wondfo) and M/s Gene2me (Livzon) were sent to the field.
"When complaints were received from states of Rajasthan, Punjab, Karnataka regarding non-performance of the antibody test kit in the field, and based upon the said feedback from the field, those purchase orders were cancelled without any payment," the minister said in his reply.
"Simultaneously, the licenses of these companies were also cancelled by Drug Controller General," he said.
The minister further replied in negative to a question on whether there exists any complaints against massive profiteering and over-pricing in kits imported from China.
However, a public grievance was received primarily describing a commercial dispute amongst different distributors of the kits supplied by Wondfo company, China, Choubey said.
The ICMR is not a party to the said dispute among different distributors of a commercial entity.
As there was no payment made by ICMR to any supplier, there was no further action to be taken by ICMR.
Stating whether the government has taken any action or proposes to take any action against the persons involved in this serious lapse, the minister said that 17 importers were issued licenses between March 23 and April 24 for import of antibody rapid diagnostic kits from China under Medical Devices Rules, 2017 subject to various conditions.
ICMR reported that the above test kits do not meet the specification in the field and issued orders on April 26 cancelling the purchase orders.
Pursuant to above information from ICMR, the importers were issued directions on April 28 to stop import of the said diagnostic kits as well as they were asked to show cause as to why action will not be taken to suspend or cancel their licenses.
Subsequently, on April 29, after verification of the responses, as received, the importers were directed that no batches of the said diagnostic kits should be imported for sale/stock/distribution or be sold or offered for sale.
Further, they directed that entire batches imported and supplied, should be recalled from the market including hospitals and accordingly, their import licenses were made infructuous and cancelled with immediate effect, Choubey said.
Informing the steps taken by the government to ensure availability of genuine testing kits to combat the disease, the minister said detailed requirements and conditions of the manufacturing/import license required to be complied by the licensee are prescribed in the MDR 2017.
In addition, the ICMR in co-ordination with CDSCO has issued guidelines for validation and batch testing of COVID-19 diagnostic kits and for validation centres.
Acceptance criteria for COVID-19 diagnostic kits and regents has been fixed by the ICMR experts group for testing product and quality at the ICMR designated labs to ensure the quality of the product for recommendation to use in the country for testing patient samples, the minister said.