Coal-gate: Sonia may ask ‘tainted’ Sahai, Jaiswal to go

New Delhi, Jun 8: India on Monday reported the highest single-day spike of 9,983 more COVID-19 cases and 206 deaths in the last 24 hours.

With this, the country's coronavirus count has reached 2,56,611, including 1,25,381 active cases, according to the Ministry of Health and Family Welfare.

1,24,094 patients have been cured/discharged so far and 7,135 succumbed to the deadly virus. While one patient has migrated.

With 85,975 cases, Maharashtra is the worst-affected state in the country followed by Tamil Nadu at 31,667 cases.

A total of 1,08,048 samples were tested for coronavirus in the last 24 hours and overall 47,74,434 samples have been tested till now.

New Delhi, Jul 6: The Indian Academy of Sciences, a Bengaluru-based body of scientists, has said the Indian Council for Medical Research's (ICMR) target to launch a coronavirus vaccine by August 15 is "unfeasible" and "unrealistic".

The IASc said while there is an unquestioned urgent need, vaccine development for use in humans requires scientifically executed clinical trials in a phased manner.

While administrative approvals can be expedited, the "scientific processes of experimentation and data collection have a natural time span that cannot be hastened without compromising standards of scientific rigour", the IASc said in a statement.

In its statement, the IASc referred to the ICMR's letter which states that "it is envisaged to launch the vaccine for public health use latest by 15th August 2020 after completion of all clinical trials".

The ICMR and Bharat Biotech India Limited, a private pharmaceutical company, are jointly developing the vaccine against the novel coronavirus -- SARS-CoV-2.

The IASc welcomes the exciting development of a candidate vaccine and wishes that the vaccine is quickly made available for public use, the statement said.

"However, as a body of scientists including many who are engaged in vaccine development IASc strongly believes that the announced timeline is unfeasible. This timeline has raised unrealistic hope and expectations in the minds of our citizens," it said.

Aiming to launch an indigenous COVID-19 vaccine by August 15, the ICMR had written to select medical institutions and hospitals to fast-track clinical trial approvals for the vaccine candidate, COVAXIN.

Experts have also cautioned against rushing the process for developing a COVID-19 vaccine and stressed that it is not in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential.

The IASc said trials for a vaccine involve evaluation of safety (Phase 1 trial), efficacy and side effects at different dose levels (Phase 2 trial), and confirmation of safety and efficacy in thousands of healthy people (Phase 3 trial) before its release for public use.

Clinical trials for a candidate vaccine require participation of healthy human volunteers. Therefore, many ethical and regulatory approvals need to be obtained prior to the initiation of the trials, it added.

The IASc said the immune responses usually take several weeks to develop and relevant data should not be collected earlier.

"Moreover, data collected in one phase must be adequately analysed before the next phase can be initiated. If the data of any phase are unacceptable then the clinical trial is required to be immediately aborted," it said.

For example, if the data collected from Phase 1 of the clinical trial show that the vaccine is not adequately safe, then Phase 2 cannot be initiated and the candidate vaccine must be discarded.

For these reasons, the Indian Academy of Sciences believes that the announced timeline is "unreasonable and without precedent", the statement said.

"The Academy strongly believes that any hasty solution that may compromise rigorous scientific processes and standards will likely have long-term adverse impacts of unforeseen magnitude on citizens of India," it said.

New Delhi, Mar 6: Union Finance Minister Nirmala Sitharaman on Friday will move the Insolvency and Bankruptcy Code (Second Amendment) Bill, 2019 for consideration and passing in Lok Sabha.

In December last year, the Union Cabinet had approved a proposal to promulgate an ordinance to amend the Insolvency and Bankruptcy Code (IBC) 2016.

The amendments will remove certain ambiguities in the IBC 2016 and ensure smooth implementation of the code, an official statement said.

The move is aimed at easing the insolvency resolution process and promoting the ease of doing business. Aimed at streamlining of the insolvency resolution process, the amendments seek to protect last-mile funding and boost investment in financially-distressed sectors.

Under the amendments, the liability of a corporate debtor for an offence committed before the corporate insolvency resolution process will cease.

The debtor will not be prosecuted for an offence from the date the resolution plan has been approved by the adjudicating authority if a resolution plan results in change in the management or control of the corporate debtor to a person who was not a promoter or in the management or control of the corporate debtor or a related party of such a person.

The amendments are aimed at providing more protection to bidders participating in the recovery proceedings and in turn boosting investor confidence in the country's financial system.