Serum Institute of India gets nod for phase 2,3 trials of Oxford covid vaccine

Agencies
August 3, 2020

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. 

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Agencies
June 13,2020

New Delhi, Jun 13: In a bid to provide relief to small businesses amid the coronavirus pandemic, the GST Council on Friday decided to halve the interest rate on late filing of GSTR-3B returns for the period of February, March and April 2020.

The interest rate on late return filing will be 9% from the usual 18% till September 30, 2020. The benefit will be available for small taxpayers with aggregate turnover of up to Rs 5 crore.

For the three months, small taxpayers will not be charged any interest till the notified dates for relief and thereafter 9% interest will be charged till September 30, a Finance Ministry statement said.

"For small taxpayers (aggregate turnover upto Rs 5 crore), for the supplies effected in the month of February, March and April 2020, the rate of interest for late furnishing of return for the said months beyond specified dates (staggered upto 6th July 2020) is reduced from 18 per cent per annum to 9 per cent per annum till 30.09.2020," said the statement.

The Council has also extended relief to small taxpayers for subsequent period of 2020 through waiver of late fees and interest if the returns in Form GSTR-3B for the supplies effected in the months of May, June and July are furnished by September 2020.

It has also decided to reduce the late fee on the filing of GSTR-3B returns for the period between July 2017 and January 2020. The late fee has been capped at Rs 500, but interest will be charged at the existing rate on the due tax liability.

Speaking to the media in New Delhi after a GST Council meet through videoconference, Union Finance Minister Nirmala Sitharaman said that those entities with no tax liability will not have to submit the late fee for the period.

For entities with tax liability but which have not filed returns or have filed returns late, the late fee has been capped at Rs 500 without interest. Interest will, however, be payable on the tax component at the applicable rate for delays.

To facilitate taxpayers who could not get their cancelled GST registrations restored in time, the Council has provided an opportunity for filing of application for revocation of cancellation of registration up to September 30, 2020, in all cases where registrations have been cancelled till June 12, 2020.

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News Network
March 29,2020

Theni, Mar 29: A young man under home quarantine for coronavirus after return from Sri Lanka suddenly ran out of his house and fatally bit a 80-year old woman in his neighbourhood in a village near here, police said on Saturday.

The woman with injuries in her neck was hospitalised late Friday after the incident but died on Saturday without responding to treatment, they said.

The man, a resident of Jakkamanayakanpatti and engaged in seasonal business in clothing, was overpowered and handed over to police, who arrested him and investigations were on.

He had recently returned from Sri Lanka and directed to remain under quarantine by health authorities as per the protocol for foreign returnees to check coronavirus spread.

He came out of his house on Friday evening and all of a sudden, denuded himself and began running through the street.

Shocked family members including his father gave a chase even as he caught hold of Nachiyammal, seated on her house’s front yard and bit hard her neck.

The man’s kin overpowered him and admitted the woman to nearby Bodi Government Hospital where doctors on Saturday said she succumbed to her injuries, not responding to treatment. Health authorities were unavailable for comments immediately.

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News Network
February 14,2020

New Delhi/Washington, Feb 14: India has offered to partially open up its poultry and dairy markets in a bid for a limited trade deal during US President Donald Trump's first official visit to the country this month, people familiar with the protracted talks say.

India, the world's largest milk-producing nation, has traditionally restricted dairy imports to protect the livelihoods of 80 million rural households involved in the industry.

But Prime Minister Narendra Modi is trying to pull all the stops for the US President's February 24-25 visit, aimed at rebuilding bonds between the world's largest democracies.

In 2019, President Trump suspended India's special trade designation that dated back to 1970s, after PM Modi put price caps on medical devices, such as cardiac stents and knee implants, and introduced new data localization requirements and e-commerce restrictions.

President Trump's trip to India has raised hopes that he would restore some of the country's US trade preferences, in exchange for tariff reductions and other concessions.

The United States is India's second-largest trade partner after China, and bilateral goods and services trade climbed to a record $142.6 billion in 2018. The United States had a $23.2 billion goods trade deficit in 2019 with India, its 9th largest trading partner in goods.

India has offered to allow imports of US chicken legs, turkey and produce such as blueberries and cherries, government sources said, and has offered to cut tariffs on chicken legs from 100 per cent to 25 per cent. US negotiators want that tariff cut to 10 per cent. The Modi government is also offering to allow some access to India's dairy market, but with a 5 per cent tariff and quotas, the sources said. But dairy imports would need a certificate they are not derived from animals that have consumed feeds that include internal organs, blood meal or tissues of ruminants.

New Delhi has also offered to lower its 50 per cent tariffs on very large motorcycles made by Harley-Davidson, a tax that was a particular irritant for President Trump, who has labelled India the "tariff king." The change would be largely symbolic because few such motorcycles are sold in India.

President Trump will be feted in PM Modi's home state of Gujarat, then hold talks in New Delhi and attend a reception that the hosts have promised will be bigger than the one organised for former president Barack Obama in 2015.

But it is far from clear whether India's offers will be enough to satisfy US Trade Representative Robert Lighthizer, who cancelled plans for a trip to India this week. Instead, he has held telephone talks with Commerce Minister Piyush Goyal.

The US dairy industry remained sceptical on Thursday that a viable deal is at hand.

"We're always looking for market access, but in terms of India, as of today I'm not aware of any real progress going on," said Michael Dykes, president of the International Dairy Foods Association and a member of USTR's agricultural trade policy advisory committee.

Mr Dykes said the US dairy industry was looking for access in viable commercial quantities.

A USTR spokesman and India's trade ministry did not respond to requests for comment.

A parliament panel is reviewing a draft data privacy law that imposes stringent controls over cross-border data flows and gives the government powers to seek user data from companies.

It is not clear whether it will be passed, or in what form, but the possibilities have unnerved US companies and could raise compliance requirements for Google, Amazon.com Inc, and Facebook.

The draft law is not part of the trade discussions, Indian officials say, because the issue is too difficult to resolve at the same time.

"The privacy and localization piece will be raised independently and in concert with the trade discussions," said a Washington-based source with knowledge of the US administration's thinking.

President Trump on Tuesday was non-committal about sealing a trade deal before his visit. "If we can make the right deal, we'll do it," he told reporters.

Two US sources said progress had been made on proposed alterations to the medical device price caps. India's new import tariffs on medical devices, walnuts, toys, electronics and other products on February 1 surprised US negotiators, however.

The new tariffs were aimed at China, which also makes medical devices, according to an Indian government source. "We have to protect our market and our companies," the source said.

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