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
February 20,2020

New Delhi, Feb 20: Hitting out at the Bharatiya Janata Party (BJP), Congress leader Sachin Sawant on Thursday said that the same BJP who tried to pressurise government lawyers so that the accused in the Malegaon bomb blast case, Samjhauta express case can be let off are now demanding that there should be a re-investigation in the 26/11 terror attacks, this is the biggest irony.

"By demanding that the case be re-investigated the BJP which gave a ticket to Pragya Thakur who was accused in the Malegaon blast case, has insulted all those brave police, the army who fought bravely. BJP should apologise to all those people," he said.

"If the BJP were serious about re-investigating the case why didn't they do it when they were in power in the state and the Centre? Was the government sleeping for the last five years? asked Maharashtra Congress committee's general secretary, Sachin Sawant.

"Rather than this, the BJP should ask for a fair inquiry in the incident where a Kashmir police officer Davindar Singh was caught in the company of terrorists and also, the role of the Sangh Parivar in the Malegaon Blasts," said Sawant.

Sawant said that BJP has crossed all limits while lying and it has stooped to the lowest levels of political discourse and is not thinking twice before defaming the Opposition.

In the book written by the retired police officer Rakesh Maria doesn't have anything other than what was there in the charge sheet on Ajmal Kasab. In his confession, Kasab has said that he was given an ID card with a Hindu name and also a red coloured thread by the Lashkar-e-taiba.

Because of this forged identity, they would be able to dodge the police. All these details have been clearly mentioned in the Kasab's confession.

Maria has mentioned in his book that if Kasab was not caught alive, the media would have declared him as a Hindu. Maria hasn't said that there was any kind of government pressure or any other conspiracy behind it. He was only talking about the media and also given all the details in the charge sheet. The BJP is only using this as a political tool in their low-class politics.

The leader added that, "The letter written by BJP MLA Atul Bhatkhalkar to CM Uddhav Thackeray has crossed all limits of lying. The Congress government in Maharashtra had formed a committee under retired home secretary Ram Pradhan to probe the 26/11 attack."

On the basis of an interview given by Ram Pradhan to a national daily on the 10th anniversary of the 26/11, he has levelled baseless allegations on former Central Home minister P Chidambaram, he added.

Bhatkhalkar in his letter has said that Chidambaram had asked Ram Pradhan to not to disclose the local connection that was found in the conspiracy. In fact, there is no such mention in the interview given by Ram Pradhan. Pradhan has said in the interview that Chidambaram wanted to see the report. Hence along with the report, some sensitive information was sent to the department separately and those were overlooked. After some time news related to David Headley had surfaced.

Ram Pradhan committee was not set up by the Centre but was set up by the state government and so it was not mandatory for the Centre to inform Ram Pradhan whether cognisance was taken regarding the sensitive information.

"In was during the Congress government that the first terrorist was caught alive due to the bravery of the police force and after following all the due procedures a verdict to hang him was given," said Sawant..

"Everyone has appreciated India's legal system in which even a terrorist was allowed to give his side," he added.

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News Network
February 6,2020

Feb 6: India has been ranked 40th out of 53 countries on a global intellectual property index, even as the country has shown improvement in terms of scores when it comes to the protection of IP and copyright issues, a top American industry body said on Wednesday.

India was placed at 36th position among 50 countries in 2019.

India's score, however, increased from 36.04 per cent (16.22 out of 45) in 2019 to 38.46 per cent (19.23 out of 50) in 2020, a 2.42 per cent jump in an absolute score.

However, India's relative score increased by 6.71 per cent, according to the International IP Index released by Global Innovation Policy Center or GIPC of the US Chambers of Commerce.

This year, it finds itself on the 40th place among 53 countries. Two new Index economies (Greece and the Dominican Republic) scored ahead of India. The Philippines, and Ukraine leapfrogged India.

"Since the release of the 2016 National IPR Policy, the government of India has made a focused effort to support investments in innovation and creativity through increasingly robust IP protection and enforcement," the GIPC said.

Since 2016, India has improved the speed of processing for patent and trademark applications, increased awareness of IP rights among Indian innovators and creators, and facilitated the registration and enforcement of those rights, it added.

According to the eighth edition of the annual report, India's score on the Chamber's International IP Index demonstrates the country's growing investment in IP-driven innovation and creativity. The Index specifically highlights a number of reforms over the last year that strengthen India's overall IP ecosystem, it said.

"In 2019, the Delhi High Court used dynamic injunctions to disable access to copyright-infringing content online, resulting in an increase in India's score on two of the copyright-related indicators," it said.

"The use of these injunctions places India alongside global leaders in copyright enforcement, including Singapore and the UK. As a result, India scores ahead of 24 other economies in the copyright indicators," the report said.

The Delhi High Court also issued a series of judgements that provide clarity on existing statutes related to trademark protection online, resulting in a score increase on one of the trademark-related indicators, it added.

The courts issued two precedential rulings that raised the bar for the damages awarded in IP-infringement cases and may provide a deterrent for future infringement. This resulted in an increase in score on one of the trademark-related indicators, it said.

Global Innovation Policy Center or GIPC said India also continues to score well in the Systemic Efficiency indicator, scoring ahead of 28 other economies in these indicators.

"This is a result of a concerted effort by the Indian government to consult with stakeholders during IP policy formation and create greater awareness about the importance of IP protection,” it said adding that India also remains a leader in the use of targeted incentives and IP assets for small and medium-sized enterprises (SMEs).

“To continue this upward trajectory, much work remains to be done to introduce transformative changes to India’s overall IP framework and take serious steps to consistently implement strong IP standards," the report said.

GIPC has identified several challenges for India. Prominent among them being patentability requirements, patent enforcement, compulsory licensing, patent opposition, regulatory data protection, transparency in reporting seizures by customs, and Singapore Treaty of Law of TMs and Patent Law Treaty.

"We are encouraged that Indian policymakers seem to recognize this Index as a valuable resource in their efforts to strengthen the country’s promising innovation ecosystem and enhance its competitiveness in an increasingly knowledge-based global economy,” the report said.

Observing that no other economy stands to gain more from strong Indian IP than India itself, the report said for example, no industry has been hurt more by copyright violations in India than the country’s own Bollywood industry, which loses almost USD3 billion to piracy each year.

"The number one way the Modi administration can demonstrate its commitment to the success of the Atal Innovation Mission, Accelerating Growth for New India’s Innovations, Make in India, Digital India, and Startup India is to strengthen its IP framework in ways that promote the legal and regulatory certainty necessary for greater R&D investment, high-value jobs, and greater innovative and creative outputs,” it said.

"Strong IP standards can further solidify India's position as the world’s fastest-growing economy, bolstering its reputation as a destination for doing business, foreign businesses’ ability to invest and make in India, thereby supporting the growth of India’s own innovative and creative industries," the report said.

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News Network
June 17,2020

New Delhi, 17: Tensions on the Indo-China border have spiked to the highest since 1962 after over 20 troops, including an Indian commanding officer, were killed in the face-off in Galwan valley that has seen a six-week long standoff underway with the Peoples Liberation Army.

The Army said that the soldiers – including the Commanding Officer of 16 Bihar regiment in charge of the area – died while a `de-escalation process’ was underway. Sources said that this death toll could rise up as some soldiers are currently not accounted for after PLA troops attacked with spiked sticks and stones in the Galwan valley.

Chinese side also has casualties but the number is still not known. The Indian death toll is perhaps the worst single day loss in decades and has come at a time when thousands of troops are forward deployed in Eastern Ladakh.

ET was the first to report on May 12 about a massive troop build up in the Galwan valley, which is an old flashpoint that had seen action in the 1962 war as well.

There have been reports of casualties on the Chinese side in the clash but numbers are currently not available. Worryingly, information from the ground suggests that several Indian soldiers, including four officers, are missing and could have been taken captive by a vastly larger Chinese force. Their status is still not known.

“During the de-escalation process underway in the Galwan Valley, a violent face-off took place yesterday night with casualties. The loss of lives on the Indian side includes an officer and two soldiers. Senior military officials of the two sides are currently meeting at the venue to defuse the situation,” an Indian Army statement reads.

The Ministry of External Affairs said that the clash occurred when the Chinese side violated the LAC. “On the late-evening and night of 15th June, 2020 a violent face-off happened as a result of an attempt by the Chinese side to unilaterally change the status quo there. Both sides suffered casualties that could have been avoided had the agreement at the higher level been scrupulously followed by the Chinese side,” a statement reads.

The loss of the Commanding Officer is especially devastating and he had been directly involved in de-escalation talks with the Chinese side, including one hours before the clash took place. Sources said that the talks on Monday morning had led to an agreement for Chinese forces to withdraw from Indian territory as part of the disengagement.

According to one version, the CO had gone to the standoff point with a party of 50 men to check if the Chinese had retreated as promised. As the Indian side proceeded to demolish and burn illegal Chinese structures on its side of the LAC, including an observation post constructed on the South bank of the river, a fresh stand off took place as a large force of Chinese troops returned back.

Sources said that a Chinese force in excess of 250 quickly assembled near Patrol Point 14 and were physically stopped by Indian soldiers from entering Indian territory. Soldiers from both sides did not use firearms but the Chinese soldiers carried spiked sticks to attack.

Given the terrain of the region, a part of the standoff and clash took place in the middle of the Galwan river that is currently flowing at full spate, leading to high casualties as injured soldiers got swept away. Indian soldiers have to cross the Galwan river at atleast five points to reach PP 14, which marks the LAC.

Chinese media reports on Tuesday quoted the spokesperson from its Western Theatre Command as laying claim over the Galwan valley region and blaming the Indian side for the clash. Reports quoted Col Zhang Shuili as saying that India has violated the consensus made during Army commander level talks.

As reported, Galwan river area has a painful history with China, with Peoples Liberation Army (PLA) soldiers surrounding a freshly set up Indian Army post in July 1962, in what would be one of the early triggers to the Sino-Indian war. At an Army post that was overrun at Galwan, 33 Indian soldiers were killed and several dozen taken captive in 1962.

In the past, the Doklam crisis in 2017 saw tensions building up along the Pangong Tso lake as well with soldiers engaging in a fight with sticks and stones. However, the Eastern Ladakh standoff is of a much more serious nature, with over 6000 Chinese troops lined up with tanks and artillery, faced off with a larger Indian forces. Troop build up has also been reported across the borders in Himachal Pradesh, Uttarakhand, Sikkim and Arunachal.

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