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The Drugs Controller General of India (DCGI) has given nod to the Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford University developed Covid-19 vaccine candidate in the country.

Government officials said that the approval for conducting phase 2 and 3 clinical trials by the SII was granted by DCGI Dr V G Somani late Sunday night after a thorough evaluation based on the recommendations of the Subject Expert Committee (SEC) on Covid-19.

"The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials," a senior official said.

"As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals," the official said.

As a rapid regulatory response, the expert panel at the Central Drugs Standard Control Organisation (CDSCO) on Friday, after a detailed deliberation and considering the data generated on the vaccine candidate in phase 1 and 2 of the Oxford University trial, had recommended granting permission for phase 2 and 3 clinical trials of the potential vaccine, 'Covishield', on healthy adults in India,  the officials said.

Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.

The officials said that the SII had submitted a revised proposal on Wednesday after the SEC on July 28, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information.

The panel had also recommended that the clinical trial sites which have been proposed for the study be distributed across India.

According to the revised proposal by the SII, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS-Delhi, B J Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore.

"According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' on healthy Indian adults," the official said.

The SII, which has partnered with AstraZeneca, for manufacturing the Oxford vaccine candidate for Covid-19 had submitted its first application to the DCGI on July 25 seeking permission for conducting the phase 2 and 3 trials of the potential vaccine. 

Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the UK showed that it has an acceptable safety profile and homologous boosting increased antibody response, sources had said.

To introduce the vaccine, SII, the world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca. 

New Delhi, Jul 29: The new National Education Policy (NEP) approved by the Union Cabinet on Wednesday is set to usher in a slew of changes with the vision of creating an education system that contributes directly to transforming the country, providing high-quality education to all, and making India a global knowledge superpower.

The draft of the NEP by a panel headed by former Indian Space Research Organisation (ISRO) chief Kasturirangan and submitted to the Union Human Resource Development Minister Ramesh Pokhriyal when he took charge last year. The new NEP replaces the one formulated in 1986.

Some of the key highlights of the New Education Policy are:-

The policy aims to enable an individual to study one or more specialized areas of interest at a deep level, and also develop character, scientific temper, creativity, spirit of service, and 21st century capabilities across a range of disciplines including sciences, social sciences, arts, humanities, among others.

It identified the major problems facing the higher education system in the country and suggested changes such as moving towards multidisciplinary universities and colleges, with more institutions across India that offer medium of instruction in local/Indian languages, a more multidisciplinary undergraduate education, among others. 

The governance of such institutions by independent boards having academic and administrative autonomy has also been suggested.

Under the suggestions for institutional restructuring and consolidation, it has suggested that by 2040, all higher education institutions (HEIs) shall aim to become multidisciplinary institutions, each of which will aim to have 3,000 or more students, and by 2030 each or near every district in the country there will be at least one HEI.

The aim will be to increase the Gross Enrolment Ratio in HEIs including vocational education from 26.3 per cent (2018) to 50 per cent by 2035.

Single-stream HEIs will be phased out over time, and all will move towards becoming vibrant multidisciplinary institutions or parts of vibrant multidisciplinary HEI clusters.

It also pushes for more holistic and multidisciplinary education to be provided to the students.