Pranab Mukherjee hails Election Commission

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.

Jul 2: Democratic presidential candidate and former US vice-president Joe Biden has said that if he wins the November elections, strengthening the relationship with India which is America’s "natural partner", will be a high priority for his administration.

"India needs to be a partner in the region for our safety's sake and quite frankly for theirs," he said in response to a question on India-US relationship during a virtual fundraiser event on Wednesday.

At the fundraiser hosted by Chairman and CEO of Beacon Capital Partners Alan Leventhal, the former vice president said that India and the United States were natural partners.

"That partnership, a strategic partnership, is necessary and important in our security," Biden said when asked by an attendee whether India is critical to the US' national security.

Referring to his eight years as the vice president, he said, "In our administration, I was proud to play a role more than a decade ago in securing Congressional approval for the US-India Civil Nuclear Agreement, which is a big deal".

"Helping open the door to great progress in our relationship and strengthening our strategic partnership with India was a high priority in the Obama-Biden administration and will be a high priority if I'm elected president,” Biden said.

Both as the vice president and a senator from Delaware, he was a big supporter of India-US relationship.

About the November polls, Biden said that the character of the country is on the ballot. The upcoming election is the most important poll of a lifetime and that the country is currently engaged in a battle for its soul, he claimed.

Biden also slammed President Donald Trump and his administration over the handling of the coronavirus pandemic.

"Trump ignored warnings from the very beginning, refused to prepare and failed to protect the country. Not just now but throughout his presidency, undermining the very core pillars of ours, what I would argue, moral and economic strength.

"I really do believe that our country is crying out for leadership and maybe even more important, some healing. Today, we have an enormous opportunity not only to rebuild but to build back better than before. To build a better future. That's what America does," he added.

Mar 16: An investigation into Coffee Day Enterprises Ltd., initiated by its board after the death of founder V.G. Siddhartha, is likely to conclude that at least Rs 2,000 crore is missing from its accounts, according to people familiar with the matter.

The months-long probe following the suicide of Siddhartha in July examined the financial transactions of India’s largest coffee chain and its dealings with dozens of private companies owned by the entrepreneur. The draft report, running more than a hundred pages, points to thousands of rupees that have gone missing, said the people, asking not to be named because the details aren’t public. It also details hundreds of transactions between the founder’s listed and personal businesses that were not conducted at arm’s length, they said.

Though the report is in its final stages, the precise details could change before its release, expected as early as this week, the people said. The missing funds could total more than Rs 2500 crore, one person said.

“The investigation report is still a work in progress, and not finalized,” a spokesman for the company said. “The board of directors and the company are unaware of its content at this point of time. Hence it would be premature to speculate on the investigation findings.”

The priority for management and Siddhartha’s family “is to keep the business running in a challenging environment and meet all stakeholder commitments, including 30,000 jobs associated with the group,” the spokesman added.

The disappearance of the 59-year-old founder last year stunned India’s business community. He had last been seen telling his driver he was going for an evening walk along a bridge in southern India; his body was found by local fishermen two days later. A letter delivered to Coffee Day’s board and employees, which appeared to be signed by Siddhartha, described massive debts and complained of pressure from lenders and tax authorities. It claimed he bore sole responsibility for the company’s financial transactions.

The probe began about a month later when the company brought in Ashok Kumar Malhotra, a retired senior official from India’s federal enforcement agency, to investigate. A senior lawyer practicing in India’s top court is assisting, the company said in a regulatory filing at the time.

The publicly traded Coffee Day was supposed to be India’s answer to Starbucks Corp. More than 1,500 of its Café Coffee Day outlets blanketed cities and highways, with affordable options for the country’s aspiring middle classes. The chain’s tagline: “A lot can happen over coffee.”

But the empire has been battered since the founder’s death. Its shares plummeted about 90% and its market value dropped to about $80 million. Trading was suspended in February.

India’s regulators are tracking the situation and may use the company’s final report as part of a deeper dive into its internal affairs, the people said. Coffee Day showed about Rs 2400 crore in cash and cash equivalents on its balance sheet as of March 2019, the most recent figures the company has issued.

After the death of Siddhartha however, the company faced a severe liquidity crunch and had “zero cash in the bank,” according to one of the people. It struggled with day-to-day expenses and paying salaries has been a strain, the person said.

The draft report details personal guarantees by Siddhartha for loans taken by Coffee Day, and his unsecured loans at high interest rates from local money lenders, the people said. It also probes Coffee Day’s defaults to coffee growers and other vendors, they said.

A related issue is that coffee estates owned by Siddhartha and several employees had been used as collateral for bank loans. The report found that valuations for properties were inflated to get the loans, one person said.

Investigators have examined several theories about what happened to the company’s money, including whether Coffee Day was manipulating its finances to show cash and profit and whether Siddhartha was taking cash out of the listed company to pay off a large investor to whom he had guaranteed a return, the person said. From the filings of his listed and private companies, the entrepreneur’s loans had totaled more than Rs 10,000 crore, and he had been squeezed by borrowing to repay interest on earlier loans, the person said.

In the letter purportedly from Siddhartha, the entrepreneur said he had tried his best but failed as an entrepreneur. “I am solely responsible for all mistakes,” the letter read. “Every financial transaction is my responsibility. My team, auditors and senior management are totally unaware of all my transactions. The law should hold me and only me accountable, as I have withheld this information from everybody including my family.”

As the report nears release, Coffee Day is finalizing a deal with Blackstone Group Inc. for real estate assets. A large tranche of the payment is due in about a week, one person said.

Coffee Day said it is working to reduce its debt load by divesting non-core enterprises.

“The aim is to save employment and preserve this iconic Indian brand,” the spokesman said.