ANSWER
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND
FAMILY WELFARE
(SHRI ASHWINI KUMAR CHOUBEY)
(a) Central Drugs Standard Control Organisation (CDSCO) has informed that it has granted test license permission for manufacture of COVID-19 Vaccine for preclinical test, examination and analysis to the following manufacturers in India:
1. M/s Serum Institute of India Pvt., Ltd., Pune
2. Ms. Cadila Healthcare Ltd., Ahmadabad
3. M/s Bharat Biotech International Ltd., Hyderabad
4. Biological E Ltd., Hyderabad
5. M/s Reliance Life Sciences Pvt Ltd., Mumbai
6. M/s Aurbindo Pharma Limited, Hyderabad
7. M/s Gennova Biopharmaceuticals Limited, Pune
The Indian Council of Medical Research (ICMR), an autonomous organisation under the Department of Health Research, has informed that it is facilitating the following studies related to COVID-19 vaccines:
(i) An inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 has been developed by Bharat Biotech International Ltd (BBIL) using the virus isolate (NIV-2020-770) provided by ICMR-National Institute of Virology (NIV), Pune. Characterization of the vaccine candidate has been undertaken at ICMR-NIV followed by safety and tolerability studies in small animals like rats, mice and rabbits. Status of clinical trials is as follows:
• Phase I clinical trials alongwith parallel studies in hamsters and rhesus macaques have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress.
• Phase II clinical trials are ongoing.
(ii) A DNA vaccine (ZyCov-D) has been developed by Cadila Healthcare Ltd. Pre- clincial toxicity studies were conducted in small animals: mice, rats, rabbits and guinea pigs. The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR for conduct of parallel pre-clinical studies in rhesus macaques. Status of clinical trials is as follows:
• Phase I clinical trials have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress.
• Phase II clinical trials are ongoing.
(iii) Serum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates:
• ChAdOx1-S, which is a non- replicating viral vector vaccine developed by University of Oxford/AstraZeneca. This vaccine is undergoing phase III clinical trials in Brazil. Phase II/III bridging studies have been initiated by ICMR at 14 clinical trial sites. ICMR-National Institute for Research in Tuberculosis (NIRT), Chennai is the lead institution.
• ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from USA. The trial will be initiated in second half of October after the vaccine is manufactured by SII. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune.
As per details provided by Department of Biotechnology (DBT)/Department of Science and Technology (DST), more than 30 vaccine candidates have been supported which are in different stages of development.
(b) to (d) Government of India has taken a series of actions to prevent, control and mitigate the impact of COVID-19. India followed a whole of Government and whole of society approach. Hon’ble Prime Minister, a High level Group of Ministers (GoM), Cabinet Secretary, Committee of Secretaries and senior officers in MoHFW continue to monitor public health response to COVID-19 in the country.
The 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 inflow of international travellers, till such time, commercial flights were suspended on 23rd March, 2020. Till then, a total of 14,154 flights with 15,24,266 passengers have been screened at these airports. Screening was also done at 12 major and 65 minor ports and land border crossings. In the initial part of the pandemic, India evacuated a large number of stranded passengers from then COVID affected countries (China, Italy, Iran, Japan, Malaysia) and again in the un-lockdown phase, a total of 13,18,891 passengers have been brought back (as on 14th September, 2020) and followed up.
Integrated Disease Surveillance Programme (IDSP) is conducting contact tracing through community surveillance. 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 containment strategy. As on 14th September 2020, a total of about 40 lakh persons have been kept under surveillance. According to ICMR a total of 1717 COVID 19 testing laboratories are registered on its portal comprising 1049 Government labs and 668 Private labs. In addition, ICMR has 5134 Antigen testing sites entered in their database as on 17.09.2020. ICMR has informed that till 13.09.2020, a total 5,72,39,428 COVID 19 tests have been performed by the testing laboratories, of which 48,46,427 have been reported as COVID 19 infected.
Guidelines on Clinical management of COVID-19 have been issued and are being updated regularly.
States are being supported in terms of supply of logistics. So far 3.44 crores N-95 masks, 10.84 crore tablets of Hydroxychloroquine and 30,663 ventilators and 1,02,400 oxygen cylinders have been supplied to States/UTs/ Central Government hospitals so far (as on 14th September, 2020).
Various cadres of personnel and volunteers across sectors and departments for COVID related works and maintenance of other essential medical services have been worked out, trained through resources made available on the website of MoHFW, iGOT (online platform) by DOPT (https://igot.gov.in/igot/).
MoHFW website is being updated daily to provide general public with information on current status of COVID-19 spread in India. Communication material is also being hosted on MoHFW website and through social media. A dedicated call centre / helpline (1075) has been started to guide community at large which are being used by the citizens very effectively and on a regular basis.
For appropriate management of COVID-19 cases, a three tier arrangement of health facilities [(i) COVID Care Center with isolation beds for mild or pre-symptomatic cases; (ii) Dedicated COVID Health Centre (DCHC) with oxygen supported isolation beds for moderate cases and (iii) Dedicated COVID Hospital (DCH) with ICU beds for severe cases] has been implemented.
Tertiary care hospitals under ESIC, Defence, Railways, paramilitary forces, Steel Ministry etc. have been leveraged for case management. In addition, Defence Research and Development Organisation (DRDO) has set up large field hospitals with capacities ranging from 1000 to 10,000 isolation beds.
Clinical management protocol for managing COVID cases has been developed and widely circulated to improve patient outcomes.
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