Mumbai-based Haffkin Institute has received permission from the Centre on Thursday to manufacture Bharat Biotech’s Covaxin on the basis of transfer of technology.
The owner of the institute, the Maharashtra government thanked PM Modi for the approval and tweeted, “The Dept. Of Science and Technology, Government of India, has granted approval to Haffkin Institute to produce Bharat Biotech’s CovaxinCovaxin vaccine on a transfer of technology basis.”
“CM Uddhav Balasaheb Thackeray has thanked Prime Minister for approving this request,” the tweet from the CM Office added.
Maharashtra is currently among the highest Covid case spike states.
The Union Government has today issued the Regulatory Pathway in India for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL).
In a radical reform measure, the Union Government on 13th April 2021 had approved a significant streamlining and fast tracking of regulatory system for COVID-19 vaccines approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan or which are listed in WHO Emergency Use Listing (EUL). This decision will facilitate quicker access to such foreign vaccines by India and would encourage imports including import of bulk drug material, optimal utilization of domestic fill and finish capacity etc., which will in turn provide a fillip to vaccine manufacturing capacity and total vaccine availability within the country.
The Central Drugs Standards Control Organization (CDSCO) headed by DCGI has today explained that the following would be the Pathway:
- CDSCO shall prepare detailed guidelines specifying regulatory pathway for approval of foreign approved Covid vaccines based on NEGVAC recommendations.
- These guidelines have since been prepared and posted by CDSCO on its website. CDSCO will take steps to widely disseminate these guidelines to the concerned stakeholders.
- Applicants for grant of approval for Restricted Use in Emergency situation may be submitted to CDSCO.
- Application can be made by the foreign manufacturer through its Indian subsidiary or through its authorized agent in India (in case it does not have an Indian subsidiary).
- CDSCO will process such applications for Restricted Use in Emergency Situation and DCGI will consider and take a decision within 03 working days from date of submission of complete application by the applicant.
- DCGI will issue permission for Restricted Use in Emergency situation with, inter-alia, the following conditions:
- Vaccine shall be used as per the guidelines prescribed under National Covid-19 Vaccination Programme.
- First 100 beneficiaries of such vaccines shall be assessed for 7 days for safety outcomes before it is rolled out for further Vaccination program.
- Applicant shall initiate conduct of post approval bridging clinical trials within 30 days of such approval.
- Applications for Restricted Use in Emergency situation for such vaccines maybe accompanied by bridging trial protocol, application for import registration certificate and application for import license.
- CDSCO will process applications for Registration Certificate (registration of oversees manufacturing site and product: in this case Covid vaccine) and Import License, within 3 working days from the date of approval of Restricted Use in Emergency Situation.
- As per the existing protocol of CDSCO for batch release of vaccines, each batch of the vaccine will be released by Central Drugs Laboratory(CDL), Kasauli before it can be used as per the guidelines prescribed under the National Covid-19 vaccination programme.
- The applicant will use Covid vaccine, after receipt of CDL approval, initially only on 100 beneficiaries and submit the safety data to CDSCO.
- CDSCO will review the safety data submitted by the applicant, and once found satisfactory, will authorise the applicant to use the vaccine.
- CDSCO will approve the protocol for the bridging trial in consultation with Subject Expert Committee (SEC) within 7 days of the receipt of the proposal.
- Applicant will conduct the bridging trial within the time lines specified in the approved protocol, and submit data generated in the bridging trial to CDSCO.
- After the receipt of the bridging trial results, the DCGI will review the permission granted for Restricted Use in Emergency situation.
Union Home Secretary Shri Ajay Kumar Bhalla along with Shri Rajesh Bhushan, Union Health Secretary chaired a high-level meeting today to review the status of COVID19 in Madhya Pradesh and the public health measures taken for surveillance, containment and management of COVID19 by the health authorities. Shri Iqbal Singh Bains, Chief Secretary, MP, Dr Balram Bhargava, DG ICMR, Dr (Prof) Sunil Kumar, DGHS were present along with Principal Secretary (Health), Mission Director (NHM), and State Surveillance Officers of the MP.
Madhya Pradesh has reported nearly 13.4% week-on-week increase in new COVID cases. In last two weeks, the State has seen almost 79% increase in weekly new cases. In MP, in contrast to the week 7th-13thApril 2021 in the week of 17th-23rd March 2021, RT-PCR tests have increased to 73% (from 67%) while the Antigen tests has decreased to 25% (from 31%). Issues related to adequate availability of N95 Masks, PPE Kits, HCQ tablets availability, ventilator allocation, delivery and installation along with Oxygen requirement and status of allocation of Concentrator Plants were discussed in detail in the meeting.
The Union Home Secretary highlighted critical bottlenecks in the State’s response to COVID: shortage of beds in general and oxygenated beds in particular and other hospital infrastructure.
After a detailed and comprehensive review of the status of COVID-19 in the state, including the mortality figures, the following5-fold strategy for tackling the recent surge was highlighted and discussed:
1. On the front of Testing, the State was advised to-
• Significantly increase testing in all districts with a minimum of 70% RT-PCR tests and use of Rapid Antigen Tests as screening tests in densely populated areas as well as areas where fresh clusters are emerging.
• Mandatorily subject those who have tested negative in Rapid Antigen Test (RAT) to RT-PCR test.
2. Tracing, Containment, surveillance to suppress spread
• Tracing of close contacts at least 25 to 30 such close contacts for each infected person and their isolation to be done in 72 hours.
• Do subsequent testing and follow up of all close contacts.
• Delineate Containment Zones as per proper mapping of clusters of cases & their contacts.
3. The State was advised to follow the protocol of Clinical care, treatment & support, for Home / facility care:
• Increase the number of isolation beds, oxygen beds, ventilators/ICU beds, ambulance fleet as per requirement.
• Plan for adequate oxygen supply.
• Focus on mortality reduction by early identification & complying to treatment protocols
4. On front of COVID safe behaviour, the State was advised to
• Use local political, cultural, sports, religious influencers to disseminate proper wearing of masks and maintaining physical distance.
• Use of Police Act, DM Act and other legal/administrative provisions for effective and strict enforcement.
5. Regarding the Vaccination, the State was advised to ensure-
• Time-bound plan of 100% vaccination of eligible HCWs, FLWs and eligible age groups.
India crosses 2 Lakh daily cases today.
The nation reports 2,00,739 new COVID19 cases, 93,528 discharges and 1,038 deaths in the last 24 hours, as per Union Health Ministry
Total cases: 1,40,74,564
Total recoveries: 1,24,29,564
Active cases: 14,71,877
Death toll: 1,73,123
Total vaccination: 11,44,93,238
New Delhi: Prime Minister Narendra Modi on Wednesday virtually interacted with governors and lieutenant governors of all states and union territories regarding the covid-19 situation and the ongoing vaccination drive in the country.
According to PMO, PM Modi said that the values and sense of duty of people are the biggest strengths in the battle against covid -19, along with the vaccine. He also praised the citizen who participated in this battle last year, considering it their duty, he said that the same feeling of janbhagidari (public participation) needs to be encouraged now as well.
Vice President M Venkaiah Naidu, union home minister Amit Shah and union health minister harsh Vardhan also attended the interaction.
The prime minister also mentioned that the role of the governors, through appropriate utilisation of their social capacity, thus becoming all the more critical to achieving victory over COVID -19. Governors are an important link to ensure better coordination between state governments and society, he said, adding that the combined power of all community organisations, political parties, NGOs and social institutions needs to be harnessed.
He also suggested that the governors can actively engage to ensure that social institutions collaboration seamlessly with the state governments towards micro containment.
He said that their social network can help ensure an increase in the capacity of ambulance, ventilators and oxygen in hospital. Along with spreading the message about vaccination and treatment, the governors can also spread awareness about AYUSH related remedies, according to the PMO release.
PM Modi noted that the Indian youth, the workforce, is an important part of the economy, therefore, it is important to ensure that the youth follow all covid -19 related protocols and precautions. He said that the governor’s role is also critical in ensuring the greater engagement of our students in university campuses towards this janbhagidari.
We also need to focus on better utilisation of facilities at university and college campuses, he added.
Discussing the raise in the number of covid-19 cases, he said that in this stage of fight against the virus, the country stands to gain from last years’ experience and improved healthcare capacity. he discussed the increased RT-PCR testing capacity and noted that the country has become Aatmanirbhar with respect to kits and other material related to testing.
He also emphasised the significance of increasing tracking, tracing and testing, and said that RT-PCR testing needs to be increased from 60 to70 per cent, while urging that more and more people should get tested.
He also underlined that the government is committed to ensuring adequate availability to vaccines, highlighting that India has become the fastest nation to reach the landmark of 10 crore vaccinations. Noting the positive impact of tika utsav in the last four days, he said that in this period, the vaccination drive was expanded and new vaccination centres also came up.
According to the official statement, vice president Naidu also appreciated PM Modi for leading the fight against COVID -19 and his proactive steps to develop the infrastructure required to tackle the pandemic, highlighted the contributions of the scientific community, healthcare works, sanitation workers, and other frontline workers in giving a vaccine to India and the whole world.
Naidu called upon the governors to bring up a coordinated front by leading all party meeting in their respective states and engaging with civil society organisation to spread awareness about COVID – appropriate behaviour.
Meanwhile, shah stressed the importance of saving each and every life, while the governors shared details of how their respective state are tackling the spread of the virus and coordinating activities towards ensuring a smooth implementation of the vaccination drive. As per the PMO statement, they gave suggestions for further improvements in the efforts and shared plans of how janbhagidari can be increased through the active social engagement of various groups.
India has been witnessing a massive surge in COVID-19cases and reported a record number of over 1.84 lakh infected on Tuesday.
Source: ANI
On Wednesday, the European Union said that it would get 50 million Pfizer vaccine doses earlier than expected after Denmark banned use of AstraZeneca over blood clot links.
The news broke out after U.S. drugmaker Johnson & Johnson delayed its Covid-19 shot among rising caseloads. Referring to the delay, EU Commission chief Ursula von der Leyen said “there are still many factors that can disrupt the planned delivery schedules of vaccines.”
The EMA said J&J was in contact with national authorities and recommended storing doses already received until the safety committee issued an expedited recommendation, reports Reuters.
Europe will receive BioNTech/Pfizer vaccine doses in the second quarter of this year and the delivery will start as soon as this month.
A Covid-19 patient died after he was allegedly made to wait for one and a half hour at Patna’s Nalanda Medical College & Hospital. The other hospitals did not admit him due to which he came to NMCH.
The son of the deceased said, “My father was Covid-positive. Other hospitals refused to admit him, NMCH agreed. They made us wait outside for 1.5 hours.”
Citing the unfortunate incident, Bihar Health Minister Mangal Pandey said, “For some days, the number of cases has increased in hospitals, efforts are being made to improve the facilities.”
Dr Harsh Vardhan, talking how human health could not be seen in isolation anymore, stressed on the need of ‘One Health’ approach, especially during COVID. He announced the creation of an Eco-Health initiative for India which will be supported by National Institute of One Health.
He elucidated that 64 per cent of all infectious diseases which have emerged between 1973 and 1994 had aetiology which was zoonotic in nature. While talking about zoonotic viruses, Harsh Vardhan said India is one of the four global hotspots for the emergence of zoonotic diseases and added that “we are struggling even after 15 months”.