Rotomac promoter Vikram Kothari flees after Rs 800-cr bank fraud?

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 Aug 6: In a new twist in the Vijay Mallya case, a certain document connected with the case in the Supreme Court has gone missing from the apex court files. 

A bench comprising Justices U.U. Lalit and Ashok Bhushan adjourned the hearing to August 20.

It was hearing the review plea filed by Mallya against a July 14, 2017 judgment wherein he was found guilty of contempt for not paying Rs 9,000 crore dues to banks despite repeated directions, although he had transferred $40 million to his children.

The bench was looking for a reply on an intervention application, which it seemed has gone missing from the case papers.Parties involved in the case sought more time to file fresh copies.

On June 19, the Supreme Court sought explanation from its registry regarding Mallya's appeal against the May 2017 conviction in the contempt case for not repaying Rs 9,000 crore dues to banks not listed for the last 3 years.

A bench comprising Justices Lalit and Bhushan had asked the Registry to furnish all the details including names of the officials who had dealt with the file concerning the Review Petition for last three years.

The bench said according to the record, placed before it, the review petition was not listed before the court for last three years. "Before we deal with the submissions raised in the Review Petition, we direct the Registry to explain why the Review Petition was not listed before the concerned Court for last three years," said the bench.In May 2017, the apex court held him guilty of contempt of court for transferring $40 million to his children, and ordered him to appear on July 10 to argue on the quantum of punishment.

The bench said let the explanation be furnished within two weeks. "The Review Petition shall, thereafter, be considered on merits," it added.In 2017, the apex court passed the order on a contempt petition against Mallya by a consortium of banks led by the SBI. 

The banks claimed Mallya transferred $40 million from Daigeo to his children's accounts, and did not use this money to clear his debt. Banks cited this as violation of judicial orders.

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