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Bharat Biotech’s Covaxin Gets Emergency Approval For Children Aged 2-18 years

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The Subject Expert Committee on Covid-19 has granted emergency use approval to Bharat Biotech’sBiotech’s Covaxin for children 2-18 years. In September, Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 years of age and submitted the trial data to the Drugs and Comptroller General of India (DCGI) at the start of this month.

“After detailed deliberation, the committee recommended for grant of market authorisation of the vaccine for the age group of 2 to 18 years for restricted use in an emergency,” the subject expert panel said in a statement.

The made in India vaccine will be administered in two doses, with a gap of 20 days between the first and second dose.

The emergency use authorisation, however, is subject to certain conditions. Therefore, the developer of Covaxin will continue the study as per Whole Virion, Inactivated Corona Virus Vaccine, the approved clinical trial protocol.

It will have to provide updated prescribing information/Package Insert (PI), Summary of Product Characteristics (SmPC) and factsheet.

Moreover, the firm should submit safety data, including the AEFI and AESI, with due analysis every 15 days for the first two months and months after that. After that, as per New Drugs & Clinical Trials Rules, 2019, it said.

Meanwhile, the WHO is yet to grant emergency use authorisation to Covaxin. Bharat Biotech reportedly submitted all documents required for the listing to the WHO by July 9, and the WHO review process, which takes close to six weeks, had commenced by July-end.

In August, India had also granted emergency use approval to ZyCov-D’s Covid-19 vaccine for children between the ages of 12 and 18. The vaccine was developed by pharmaceutical firm Zydus Cadila and is the first DNA vaccine to be approved globally.

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AC Approves Creation of 4 new Courts of Additional District & Sessions Judge

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The Administrative Council (AC), which met here under the chairmanship of the Lieutenant Governor, Manoj Sinha, accorded approval for the creation of four courts of Additional District & Sessions Judges at district headquarters- one each in District Samba, Bandipora, Ganderbal and Poonch.

Farooq Khan and Rajeev Rai Bhatnagar, Advisors to the Lieutenant Governor, Dr Arun Kumar Mehta, Chief Secretary, J&K and Nitishwar Kumar, Principal Secretary to the Lieutenant Governor, attended the meeting.

The Administrative Council also approved the creation of 40 new posts of different categories (10 each) at the new court complexes in the four selected districts with a financial implication of Rs. 258.245 lacs (salary) and Rs 21.657 lacs (NPS) per financial year.

The gradual increase in the population of Jammu and Kashmir has substantially enhanced the judicial workload, which has necessitated the opening of new court complexes to cater to the increased public demand.

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J&K Rolls Out Aspirational Blocks Development Programme

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For intensive and focussed development of the 44 most backward blocks of the Union territory, the Administrative Council (AC), which met here under the chairmanship of Lieutenant Governor, Manoj Sinha, approved the rollout of the prestigious ”Aspirational Blocks Development Programme”.

Farooq Khan and Rajeev Rai Bhatnagar, Advisors to the Lieutenant Governor, Dr Arun Kumar Mehta, Chief Secretary, J&K and Nitishwar Kumar, Principal Secretary to the Lieutenant Governor, attended the meeting.

The blocks identified under the Aspirational Blocks Development Programme are the most backward blocks of the UT of Jammu and Kashmir, requiring particular focus to par with other blocks. In addition, the programme aims to improve development in terms of various socio-economic parameters like education, health and wellbeing, and overall living conditions of the people.

These Aspirational Blocks shall be developed by converging various ongoing UT schemes/programmes and centrally sponsored schemes/ programmes. The District Development Commissioners will be tasked with preparing a suitable development plan. In contrast, the Planning Development and Monitoring Department will constantly monitor the district-wise progress of these blocks through a digital portal.

Under the programme, the resources will be delineated across various development sectors – poverty, health & nutrition, education, and basic infrastructure, at the district level. Additionally, an amount of Rs. 1.00 crore will be provided to each block after fulfilment of defined criteria.

The best practices implemented in the development of Aspirational Blocks will be acknowledged and duly replicated in other blocks to ensure the Union territory’s inclusive and equitable socio-economic development.

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RBI Approves Baldev Prakash As Jammu And Kashmir Bank CEO

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The Reserve Bank of India (RBI) on Wednesday approved the candidature of Baldev Prakash as Managing Director and Chief Executive Officer of Jammu and Kashmir Bank for three years; the Bank said in a note to exchanges on October 27.

The appointment is effective from the date of taking charge or April 10, 2022, whichever is earlier, the Bank said.

The Bank said that the appointment of Baldev Prakash as MD & CEO by the Bank of the Bank and the actual date of his taking charge should be communicated separately.

Previously, Baldev Prakash was working with the State Bank of India in various capacities, including as Chief General Manager responsible for framing bank-level policy and strategy for developing and providing digital and transaction banking services to all Bank corporate clients.

Besides this, Prakash has worked for over four years at Muscat (Sultanate of Oman), responsible for handling remittances business including treasury operations successfully, the Bank said.

In September this year, J&K Bank, in an exchange notification, said the board has approved fundraise up to Rs 2,000 crore subject to shareholders’ approval. The fundraiser will be a mix of debt and equity, the Bank said.

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30 Sep 2021, 1:39 AM (GMT)

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