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:
M/s Serum Institute of India Pvt., Ltd., Pune
Ms. Cadila Healthcare Ltd., Ahmadabad
M/s Bharat Biotech International Ltd., Hyderabad
Biological E Ltd., Hyderabad
M/s Reliance Life Sciences Pvt Ltd., Mumbai
M/s Aurbindo Pharma Limited, Hyderabad
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.
CDSCO has informed that it has granted permission to conduct clinical trials in various clinical trial sites such as New Delhi, Chennai, Chandigarh, Jaipur, Kanpur, Surat, Hyderabad, Pune, Mumbai, Ahmadabad, Bhubaneswar, Patna, Gorakhpur etc. and the trials are on going.
Presently, under Universal Immunization Program (UIP) vaccine distribution is based on Electronic Vaccine Intelligence Network (eVIN) system. eVIN is an internet based digital system to track routine immunization, vaccine stocks, storage temperature in about 25,000 dedicated cold chain storage points across the country as well as movement of vaccine. The vaccine is distributed to health facilities and outreach station sites, so as to reach in all areas. even system is regularly monitored by health authorities at state and district level. eVIN system is being enhanced to address the needs for distribution and tracking of COVID 19 vaccine, when it becomes available.
Further, a National Expert Group on COVID 19 vaccine has been constituted to guide the Government on:-
Prioritization of population groups for vaccination.
Selection of COVID 19 vaccine candidates.
Inventory management and delivery mechanism of the vaccine including making of vaccination process.
Selection of delivery platforms.
Cold chain and associated infrastructure for roll-out of COVID 19 vaccination etc.
The Minister of State (Health and Family Welfare), Sh Ashwini Kumar Choubey stated this in a written reply in the Lok Sabha here today.
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1. AYUSH practices inducted into the Management Protocol for COVID - 19 recovered patients Ministry of Health and Family Welfare (MoHFW) issued a protocol on Post COVID Management on 13th September, 2020. The protocol provides an integrated holistic approach for patients of COVID to care at home and is not meant to be used as preventive/curative therapy. It also states that the recovery period is likely to be longer for patients who suffered from more severe form of the disease and those with pre-existing illness. The protocol is also notable for the induction of various AYUSH practices of hea
3. Yoga in Helping Recovery of COVID-19 Patients The Central Council for Research in Yoga & Naturopathy (CCRYN), has undertaken a research project to verify the efficacy of Yoga in facilitating early recovery of COVID – 19 patients in collaboration with Rajiv Gandhi Super Speciality Hospital, Delhi, AIIMS Delhi, AIIMS Rishikesh and RML Hospital, Delhi.
Due to stringent restrictions on mass gatherings arising from the contagious nature of COVID-19, the theme for International Day of Yoga (IDY) 2020 was adopted as ‘Yoga at Home,
5. Covid-19 Testing Labs According to the Indian Council of Medical Research, an autonomous organisation under the Department of Health Research, the total number of testing labs all over India authorised and set up for testing of Covid-19 for the months of March, April, May, June and July 2020, month-wise is as under:
6. Strategic Approach to Combat Covid-19 India would be following a scenario based approach for the following possible scenarios, (i) Travel related case reported in India, (ii) Local transmission of COVID-19, (iii) Large outbreaks amenable to containment, (iv) Wide-spread community Transmission of COVID-19 disease and (v) India becomes endemic for COVID-19.
Currently many areas are experiencing large outbreaks amenable to containment. Hence a containment strategy is being followed by Government of India.
7. Early Indications of COVID 19 Pandemic Outbreak in the country Ministry of Health & Family Welfare was following the evolving situation in China, when WHO India alerted our country on 6th January, 2020 about outbreak of pneumonia of unknown origin in Wuhan city of China. The Joint Monitoring Group under Director General of Health Services to met on 8th January, 2020 to review the evolving situation in China and deliberated on public health preparedness and response strategies for the same.
Before the nationwide lockdown, a series of ac
8. Status of Development of COVID Vaccine in India While the Govt. and Industry are trying their best to make available a safe and effective vaccine for COVID-19 at the earliest, it is difficult to comment on the exact timelines in view of various complex pathways involved in vaccine development.
The Government has constituted a high-level National Expert Group on vaccine administration for COVID-19 which is chaired by Member, Niti Aayog and co-chaired by Secretary, Ministry of Health & Family Welfare. Other representatives are: Secretary,
9. Checking Overcharging by Private Hospitals 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,
10. Health Outreach Services during Covid-19 The Government has been regularly reviewing the situation in consultation with States/UTs. In order to improve the nutritional status of Women and Children, Ministry of Women and Child Development is implementing Supplementary Nutrition Programme under Anganwadi Services and Scheme for Adolescent Girls under the Umbrella Integrated Child Development Services (ICDS) Scheme to children (6 months to 6 years), Pregnant Women, Lactating Mothers and out-of-school Adolescent Girls (11-14 years). As per the dire
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14. Serological Testing at CSIR-CDRI, Lucknow for antibodies against Corona Virus (SARS-CoV-2) CSIR-CDRI (Central Drug Research Institute) is carrying out a research study that involves testing of people for antibodies against SARS-CoV-2. The serological testing is conducted from 9th-11th September. For the past 7 months we are in the midst of a pandemic of coronavirus (COVID-19) infection with more than 45 lakh individuals being infected with the virus which has resulted in more than 76,270 deaths in India.
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16. Impact of Coronavirus The sudden outbreak of COVID-19 has severely impacted some of the major economies of the world. It has affected countries across the globe including some of the major players like USA, European Union, UK, and India.Both World Bank and IMF estimate contraction in global GDP for FY 2020-21 due to the spillover effects of the lockdown to curb the spread of COVID-19 pandemic. Various sectors were affected due to the nation-wide lockdown. However, after the lockdown was relaxed, we see significant improvement
17. Treatment of Non-COVID-19 Patients During Pandemic The patients who were not suffering from Corona but still have been treated in AIIMS and Central Government run hospitals in IPD as well as in OPD after 24th March, 2020 in the country is given in Annexure.
As per the National Health Accounts (NHA) Estimates 2016-17 (latest available), public expenditure on health as a percentage of GDP is 1.2%.
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18. Assessment of COVID Prevention World Health Organization, Country office, India alerted India on 6th January, 2020 about outbreak of pneumonia of unknown origin in Wuhan city of China. WHO issued a statement on 9th January, 2020 about a novel coronavirus, which was later named as SARS-CoV-2 virus and the disease was named COVID-19 by WHO on 11th February, 2020.
The first Indian case of COVID-19 was reported on 30th January 2020. Before the Nationwide lockdown, a series of actions were undertaken in a pro-active, graded and p
19. Revised National Tuberculosis Control Programme Rapid molecular diagnostics are presently available at 1360 blocks across the country. State wise number of blocks with rapid molecular diagnostics is given below:
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20. Allocation of Funds to States for Battling COVID-19 Public health and hospitals being a State subject, the primary responsibility of treatment of COVID-19 patients lies with the respective State governments. States/UTs are using their own resources for COVID-19 management including for treatment of the patients and the details are not maintained centrally.
Besides this, States/UTs are being provided required technical and financial assistance under National Health Mission (NHM) for managing the COVID-19.
21. Malnutrition in India Malnutrition is not the direct cause of death among children under five years of age. Though it can increase morbidity and mortality by reducing resistance to infections. Malnourished children are more vulnerable to any infection than normal children. The overall under five mortality rate (number of deaths per thousand live births) has reduced from 74.3 as reported by 3rd National Family Health Survey report released in 2005-06 to 49.7 as 4th National Family Health Survey report released in 2015-16.
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