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The Drugs Controller General of India plans to come out with vaccine specific regulatory policy and a manual for regulatory requirements for commercialization of new drug and on how to conduct clinical trials in India, it was announced on Saturday.
S. Eswara Reddy, Drugs Controller General of India, Central Drugs Standard Control Organisation said that since pneumococcal is one of the major priority vaccines, they would first come out a policy to facilitate introducing indigenously-produced vaccine.
Speaking at a symposium on ‘research and development of vaccines: issues, challenges and opportunities’ organized by PC2 Scientific Services, a strategic and technical consulting company in association with Federation of Asian Biotech Associations (FABA) and CR RAO AIMSCS at University of Hyderabad, he listed out the steps being taken by his organisation to promote innovation through transparent system and regulatory changes.
Reddy said they were also in process of making new regulations for conducting clinical trials and new drugs. “We will fix time lines. 30 days will be maximum timeline for giving response to their applications. If response is not received within 30 days, the application will be deemed approved,” he said.
He also proposed to conduct symposiums across India and invite research institutions to know their regulatory challenges. The regulator will reach out to research and innovation centres by disseminating information about the regulatory requirements for commercialization of their products.
Reddy underlined the need to communicate to media the facts about the deaths due to clinical trials. He told the gathering that media gives a wrong projection about the number of deaths.
He said media reports that during last 7-8 years, 25,000 patients died during clinical trials in India while the fact is that only 5 percent of these deaths are actually due to clinical trials. “For example, during clinical trials related to cancer, patients who are already in terminal stage die. The death of such patients is not due to clinical trials,” he said.
With the drug developers and researchers raising concern about the restrictions on import of animal models, the Drug Controller General hoped that the Union Environment and Forests Ministry would look into the issue.
He said the import of animals was restricted by the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) guidelines and suggested that the innovators, industry and regulator make a joint representation on the issue.
Some participants spoke how the researchers were forced to go abroad because of non-availability of such animals in the country for studies and the restrictions on the import. Reddy said the issues was relating in the country losing its credibility and the forex reserves.
Manuel Elkin Patarroyo, the malaria vaccine scientist from Columbia, was the keynote speaker. The symposium was attended by delegates from scientific research & academic and industry both from India and abroad.
Dr. Dasari V Ravi Kumar, Director of PC2 Scientific Services, pointed out that Hyderabad is producing about 33 per cent of global vaccines dosages and 35 per cent to the pharmaceutical production in the country.(IANS)
Final preparations are in full swing at Six Senses Fort Barwara which will host the much talked about wedding of celebrity couple Vicky Kaushal and Katrina Kaif.
According to sources, the event company working for this wedding has procured crystal balls and chandeliers from abroad to give a royal look to the wedding. These will be installed in the hotel soon.
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Six Senses Hotel has also parked indicator vehicles on the road at frequent intervals for the guests to reach the hotel easily. A glass 'mandap' has been prepared and decorated in Rajwada style for the couple to take 'pheres' (rounds around the fire) as per Hindu rituals. Moreover, the glass carvings on the mandap is such that it creates an optical illusion.
This wedding ceremony will be held amidst tight security arrangements. Secret codes have been given to each of the guests, so that it is impossible to know which guest is staying in which room.
Mobile phones have been banned inside the venue. International photographers have been hired to shoot the entire wedding. The ceremonies will be held from December 7 to December 9, with bouncers and police personnel looking after the security arrangements. As many as 100 bouncers have arrived from Jaipur to look after security arrangements at the wedding.
Katrina and Vicky's wedding is to be solemnized on December 9.Unsplash
Vicky Kaushal and Katrina Kaif's outfits have been designed in Mumbai which they will wear during different wedding ceremonies.
As per information, Katrina Kaif and Vicky Kaushal are scheduled to reach Hotel Six Senses Fort Barwara located at Chauth Ka Barwara, by 9 p.m. on Monday, via car from Jaipur where both are expected to receive a grand welcome by the hotel management.
Along with Vicky and Katrina, their family members too will reach the hotel on Monday. However, some close family members and other guests will reach the venue separately. Katrina's sister Natasha and friends reached Jaipur airport on Monday afternoon from where they left for the wedding venue by car.
Katrina and Vicky's wedding is to be solemnized on December 9. (IANS/SP)
(Keywords : wedding, Bollywood, Vicky Kaushal, Katrina Kaif, Rajasthan, hotel, Fort Barwara, ceremony, photographer, bouncer, outfit)
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Meta-owned WhatsApp on Monday announced an incubator programme in India that will select 10 organisations and help them build digital solutions to tackle critical health issues.
Called the WhatsApp Incubator Programme (WIP), the initiative aims to facilitate positive and measurable health outcomes at scale by leveraging the WhatsApp Business Platform.
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"During the pandemic we have seen several innovative use cases of the WhatsApp Business Platform by government organisations, civic actors, city administrations and many more NGOs, both large and small, across sectors and locations," said Abhijit Bose, Head of WhatsApp India.
The selected organisations will also be provided with technical support in order to design, prototype and pilot their health use cases.Unsplash
Also Read : The story behind Whatsapp
"We hope the WhatsApp Incubator Programme brings forth more such innovative and unique solutions that will help solve India's healthcare needs," he said in a statement.
The selected organizations will also be provided with technical support in order to design, prototype and pilot their health use cases.
The company said that participating organizations get the opportunity to be mentored by industry experts, access on-ground ecosystems, receive support with impact measurement guidance, and a chance to network with funders to scale their use cases.
The programme, for which applications are open till December 24, is being administered by Quicksand Design Studio, WhatsApp said. (IANS/SP)
(Keywords : Whatsapp, incubator, organizations, digital, health, business, pandemic, innovative, technical)
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By D.C. Pathak
Advent of Biden Presidency with its resonating calls of 'America is back', 'we will repair our alliances' and 'will engage with the world once again' on one hand and the rise of President Xi Jinping with a stronger hold on China after the Plenary session of the 19th Central Committee of CPC, on the other, have got strategic analysts to examine if a new Cold War was already on the horizon.
India has to define its stand and negotiate its international policy keeping in view the nation's best interests of the long run. Sino- Pak military alliance that chiefly worked against India, natural friendship between the two largest democracies of the world and the need for a rapid advancement of our Defence capabilities, are the major paradigms that should determine India's approach to both development and security.
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Xi Jinping is implementing a two- fold strategy of seeking the economic route to becoming the second superpower and pursuing 'Sinicisation of Marxism' to define the future of Communist China. In a huge give and take between the Godless dictatorship of China and the fundamentalist regime of Pakistan, the former has invested on CPEC located on the territory of PoK ceded by Pakistan to China in the face of the Indian protests and got an opening into the Muslim world where sympathy for Islamic radicals has been on the rise.
Pakistan is close to the pro- US group led by Saudi Arabia and yet has a good equation with Islamic radical organizations represented by Taliban. With one leg in the camp of 'revivalists' -- Pakistan -- it mediated between the US and the Taliban on Afghanistan -- would be in a position to assure the Chinese that the Cold War game of the West using Pak-Afghan region to 'radicalise' Muslims of Xinjiang and other parts of China, would not be allowed. The axis of the two principal adversaries of India has become very active after the Indian Parliament scrapped Article 370 of the Constitution in August 2019 and converted J&K and Ladakh into union territories. India had successfully evolved a strategy of dealing with both China and Pakistan together.
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It needs to be recalled that China drew the best lessons from the demise of the USSR -- it could clearly see that the Soviet regime had become an oligarchy that ignored the internal economic decline because of which it was not able to sustain the war in Afghanistan. This led Deng Xiaoping to adopt the policy of opening the Chinese market to the world in a controlled fashion and thus initiate a process of faster economic growth on which China has not looked back. China has become the second biggest global economy by investing in markets abroad and accessing technological knowledge wherever it was available -- including the research work of the US universities where it established 'Chairs' to reach out to the same.
Xi Jinping combines the persona of Deng and Mao Zedong and while consolidating Chinese economy further, he has reverted to the concept of supremacy of the Communist Party of China as the symbol of Marxism. This has helped him, among other things, to keep his leadership going on the strength of ideology and project it as something that was free of any personal vested interest. The recent conference of the Central Committee of CPC credited Xi Jinping with achievement of the first Centennial goal of making China a 'moderately prosperous society' by 2021 -- the hundredth year of the party's existence and acknowledged his pledge to make China a 'great modern Socialist country' by 2049 -- the second centennial mission marking the completion of hundred years since Mao Zedong declared the establishment of the People's Republic of China. By highlighting the importance of 'ideology' and 'line', Xi Jinping has identified himself with the Party so completely that his leadership can not be easily challenged by any dissenters.
Under Xi Jinping, China is progressing economically and also politically extending its influence in the world taking care to buy time for its mission and somewhere following the doctrine of winning a war without a battle. It is joining multilateral platforms to create a non- combatant image, inducing economic dependence of other smaller nations on it through its Belt & Road Initiative (BRI) and forging bilateral alliances and pacts to further its geo- political advancement.
Pakistan is close to the pro- US group led by Saudi Arabia and yet has a good equation with Islamic radical organizations represented by Taliban.Unsplash
Sino- Pak strategic alliance -- an illustration of this multi-prong objective of China -- is a cause for great concern for India. China knows it can not change the Western systems and is not in a hurry to challenge the global economic order -- it is exploring alternate approaches of invading others economically and doing it successfully. As far as territorial expansion was concerned Xi's China adheres to its known 'two steps forward one step backward' strategy -- which is salami slicing of sorts -- that was in evidence on LAC as also in the Indo-Pacific. India has suitably responded to these moves on land as well as on sea by undertaking a matching military build up and actively joining in Quad, respectively.
Some analysts have perceptively noted that President Xi Jinping has embarked on a larger than life mission of surpassing Mao Zedong in building China as the dominant power of the world -- matching the place it once occupied in its civilizational history. His new strategy of bringing all 'under one heaven' compels a recall of the description the Chinese Emperor once enjoyed as the 'son of heaven'. It is remarkable that a Communist dictatorship carrying the stamp of Marxism today is deriving strength from the country's civilisational roots. This reflects the desire for world domination -- the Emperor of China expected 'tribute' from other countries as protection money.
Xi's China is also working on fail -- safe alliances -- using its economic hold as in the case of Pakistan. The defence expenditure of China has been on the rise -- in comparison to India it rose from a near parity in the Nineties to more than three times of India's defence budget, as at present. China's move forward is neither transactional nor transformational but a strategy of continuum -- steady in pace and direction --attempted on a good understanding of the global 'space' on land ,sea and air. Geo- politically China is now in the frame so far as the emerging scene of the world getting divided between two superpowers, was concerned.
The defence expenditure of China has been on the rise -- in comparison to India.Unsplash
India has set in motion a well- considered strategy of handling the economic and security challenges emanating from this situation. There was never any doubt that the US and India must together anchor the collective effort of the democratic world to counter the threat from the Communist dictatorships on one hand and that from Islamic extremists on the other.
The policy of the Modi government to have bilateral relations on the basis of mutuality of interests in the economic and security spheres has been very successful. India is enlarging the ambit of friendships with European democracies, Australia, Japan and Israel -- including association with Quad -- to promote collective security against these dangers. As a nation with a voice in the global matters pertaining to war and peace, India is working for self-reliance in the area of defence and building military strength to take on any aggressive move of the PLA on the LAC and punish Pakistan for any provocation from across the LOC.
India has maintained close friendship with Russia which has -- apart from defence deals with India -- been on the same page on the vital issues of Afghanistan and radicalization. It is the policy of mutuality of security interests in Afghanistan that has made India work in collaboration with Iran, notwithstanding the conflicts that this country had with the US and Israel. Indian diplomacy has worked hard to keep the Western powers convinced of the legitimacy of India's policy towards all these other countries.
Finally, there is an added challenge on the internal security front because of the intent of the China-Pak combine to instigate acts of terror, insurgency and sectarian discord in India in an attempt to destabilize this country. A new dimension of the domestic scene of India is the rise of civil society forums which in collusion with anti-India lobbies abroad and elements hostile to the Modi government at home, play politics by proxy on issues ranging from Kashmir to Northeast and from safety of Dalits and minorities to poverty alleviation. Fortunately, we are getting adequate Intelligence to draw a line between genuine protests and sponsored agitations.
(The writer is a former Director of Intelligence Bureau; the views expressed are personal)
(Keywords : president, prime minister, Biden, Xi Jinping, Narendra Modi, China, America, India, Pakistan, military, alliance, defence, challenge, concern, security, dominant, power, history. )
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