India revokes Mallya's passport

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, Jan 16: In trouble brewing for the Gautam Adani-led M/S Adani Enterprises, the Central Bureau of Investigation (CBI) on Thursday said that it has registered a case against former officials of the National Co-operative Consumer Federation (NCCF) and others over alleged irregularities in supply of coal to the Andhra Pradesh Power Generation Corporation (APGENCO) in 2010.

The CBI in its FIR has named Virendra Singh, the then Chairman of the NCCF, G P Gupta, the then MD of the NCCF, S C Singhal, the then Senior Advisor of NCCF, Adani Enterprises Ltd and other unknown public servants and others for criminal conspiracy, cheating and criminal misconduct by public servants.

According to CBI, the case was filed on Wednesday after the preliminary enquiry revealed the crime by the officials named in the FIR and the Adani Enterprises was found to be true.

The FIR alleged that on June 26, 2010, APGENCO floated a tender enquiry for supply of six lakh metric tonnes of imported coal "on free on rail destination" basis to Dr Narla Tata Rao Thermal Station (NTTPS), Vijaywada and Rayalasaleema Thermal Power Plant (RTTP), Kadapa, Andhra Pradesh/RTPP via Kakinada-Vizag-Chennai-Krishnapatnam or any other ports

The same was forwarded by the Chief Engineer, APGENCO to seven PSUs -- PEC Limited, STC Limited, MSTC Limited, NCCF, MMTC, Coal India Limited and SCCL Limited.

The FIR alleged that during the probe, the Adani Enterprises used a proxy company to get the supply contract. It said, "NCCF received bids from six companies -- Adani Enterprises Ltd, Maheshwari Brothers Coal Limited (MBCL), Vyom Trade Links Pvt. Ltd, Swarana Projects Pvt. Ltd, Gupta Coal India Ltd and Kyori Oremen Ltd.

During investigation it was found that Gupta Coal India Ltd had quoted the NCCF margin of 11.3 percent, while the MBCL quoted the margin of 2.25 percent and rest did not quote any margin to the NCCF.

The FIR said the quotes of the Gupta Coal India Ltd, Kyori Oremen Ltd and Swarana Projects Pvt. Ltd were rejected by the NCCF as they were not found to be fulfilling the tender conditions.

"Post tender negotiation was done by senior officials of NCCF to give undue favour to Adani Enterprises Ltd despite it not qualifing the tender (terms)," the FIR said, adding instead of cancelling the bid of Adani Enterprise Ltd, senior management of NCCF conveyed the offer margin to the company through one of its representative -- Munish Sehgal, who was sitting in the NCCF head office. It is prima facie evident that when the bids were being processed at NCCF head office in Delhi, a representative of Adani Enterprises Ltd. was informed regarding their imminent rejection due to non-submission of NCCF margin and also that MBCL was eligible bidder quoted 2.25 percent margin," it alleged.

The CBI in its FIR, further alleged that Adani Enterprises Ltd. had given an unsecured loan of Rs 16.81 crore to Vyom Trade Links Ltd in 2008-09. "And further it was revealed that the bank guarantees of the Adani Enterprises Ltd. and Vyom Trade Links Ltd. were issues by the same branch of the State Bank of India and at the same time," it said.

"It was clear that Adani Enterprises Ltd. presented Vyom Trade Links Ltd. as a proxy company in this particular tender and Vyom Trade Links Ltd. later withdrew its offer on flimsy ground," the CBI FIR said.

"The aforesaid acts of commissions and omissions on the part of the senior management of the NCCF disclose that during their tenure, they acted in a manner unbecoming of public servants and committed irregularities by way of manipulation in the selection of bidders, thereby giving undue favours to Adani Enterprises Ltd. in award of work for supply of coal to APGENCO despite its disqualification," it added.

New Delhi, Jun 23: The Delhi High Court Tuesday granted bail to Jamia student Safoora Zargar, who is pregnant and was arrested under anti-terror law UAPA in a case related to communal violence in northeast Delhi during protests against the Citizenship Amendment Act, as Solicitor General Tushar Mehta did not oppose it on humanitarian grounds.

At the outset of the hearing, Mehta, representing Delhi Police, submitted that Zargar can be released on regular bail on humanitarian grounds and the decision has not been taken on merits of the case and should not be made a precedent.

Justice Rajiv Shakdher, who conducted the hearing through video conferencing, released Zargar, who is 23-week pregnant, on bail on furnishing a personal bond of Rs 10,000 and surety of like amount.

The court said she shall not indulge in any activity for which she has been charged with and shall not hamper the investigation or influence the witnesses.