In another setback to India's biggest drugmaker Ranbaxy Laboratories Ltd, a court in Finland has prohibited it from marketing its generic version of Pfizer's cholesterol lowering drug Lipitor in the country.
The US pharma industry has expressed concern over deteriorating intellectual property environment in India, alleging that patent rights in the country are unreasonably denied.The US pharma industry has expressed concern over deteriorating intellectual property environment in India, alleging that patent rights in the country are unreasonably denied.
There is a process to be followed for EUL and pre-qualification of vaccines under which a company has to complete phase 3 trials and submit the whole data to the regulatory department of WHO which is examined by an expert advisory group," Swaminathan said.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
China has given conditional approval for a single dose COVID-19 vaccine, touted to be a rival to Johnson & Johnson's one-jab shot cleared by the United States drug regulator on Sunday.
A longer shelf life is critical, given many makers have started manufacturing vaccines and stockpiling them, so as to make them available in the market immediately after approval, reports Sohini Das.
'You will not have a vaccine for everyone initially.'
As many as 721,469 appointments were made through the national booking service on Friday -- the day of the announcement -- at an average of more than eight every second. To cope with demand, the NHS said it is using stadiums and football grounds as giant vaccination centres.
'Until the case load starts dropping, we will have to keep up the current level of prevention activities.'
The Indian government headed by Prime Minister Manmohan Singh, who is known as the architect of the country's liberalisation and economic reforms, is inching towards a "protectionist" regime, top American experts have told US lawmakers.
The Medicines and Healthcare Products Regulatory Agency said in its latest Yellow Card monitoring of the coronavirus vaccine programme this week that of the 18.1 million people who had the Oxford vaccine in the UK, 30 people developed blood clots and seven had died as of March 24.
The government said it had been evaluating the implementation of the decentralised model of vaccination since its launch on May 1 and that the decision to centralise it again was taken after detailed deliberations and following requests by some states, amid claims by the Opposition that the policy change was due to the Supreme Court's intervention.
India's generic drug manufacturer, Dr Reddy's Laboratories, suffered a setback when a US' Court of Appeals ruled that it infringed on Pfizer Pharmaceutical company's patent for the blood pressure medicine Norvasc.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
India's Supreme Court in April rejected a patent for Novartis AG's cancer drug Glivec, saying it was an amended version of a known molecule called imatinib, setting the precedent for more such cases in the country.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said healthcare workers and frontline workers need not register themselves as their database has been populated on to the Co-WIN vaccine delivery management system in a bulk manner.
'India missed the software products revolution (and now is in danger of missing the platform revolution), complacent that we are the software experts of the world based on IT services prowess,' points out Rajeev Srinivasan.
The British-Swedish pharmaceutical major and the UK's medicines regulator said that the vaccines produced by Oxford University in collaboration with AstraZeneca to protect against COVID-19 are safe.
Snooping is one of the oldest peccadilloes of man, observes Ambassador M K Bhadrakumar.
Addressing a virtual Downing Street press conference, Boris Johnson acknowledged the divided views on lifting all lockdown restrictions to declare that his update does not imply that the pandemic "is over".
'Mortality or hospitalisation has not increased in South Africa because of the new variant.' 'There is nothing to show so far that it is more infectious.' 'I am of the opinion that at the moment, there is no reason to panic.'
'A third wave is possible, but we must try to restrict it to a low level by adopting all personal protection and public policy measures to prevent viral transmission, while speeding up vaccination.'
'Ideally, the efficacy data of all the trials should be there in the public domain, and as soon as possible.' 'It is difficult to understand the reason behind the authorisation.'
'Nobody is attacking the company or the vaccine.' 'The concerns are about the process and the lack of transparency.'
Severe price cuts help multinationals ramp up growth, gain market share.
''None of the existing vaccines have 100% efficacy.' 'Each vaccine will work openly on a certain percentage of the population.'
The ministry has asked 44 pharmaceutical companies, including global drug majors such as Eli Lilly, Novartis, Pfizer, Bayer, Merck, Johnson & Johnson and Sanofi Aventis, to explain why they have not given the compensation, which is mandatory under the current drug laws.
In an effort to improve their balance sheets, many of the major multinationals have started to lay-off employees.
Currently, the govt directly caps prices of 348 formulations at the average price of all medicines in a particular segment with at least 1% market share
Interacting with state chief ministers, Modi underscored the enormity of what he described as the world's biggest vaccination exercise, which begins from January 16, saying over 30 crore citizens will get the jabs in the next few months in India against only 2.5 crore people vaccinated so far in over 50 countries in around a month.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
'We lost our place in being first in the epidemic, when it hit India so hard, but we were actually the epicentre of the epidemic from essentially April 2020, for almost an entire year. We had such high cases. We were the country that had the most mixed response.'
Bharat Biotech, Serum Institute, Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax and Biological E are among the domestic pharma firms working on the coronavirus vaccines in India.
The Clinical Research sector is emerging as an attractive option for science graduates, doctors, management/ IT professionals, alike.
However, in two different dose regimens, the vaccine's efficacy was 90 per cent in one and 62 per cent in the other.
The Delhi High Court on Friday stayed the ban on some fixed dose combination (FDC) drugs of Glaxo SmithKline, Wockhardt and Laboratories Griffon but said action against their sale could be taken in the absence of valid sale and marketing licence.
'If at all there is going to be a second wave, it will not be very strong unlike in the US and Europe.'
India's largest drug maker Ranbaxy Laboratories, which is fighting a patent battle with the world's largest drug maker Pfizer on the cholesterol lowering drug Lipitor in about 18 countries, got a mixed verdict from the Full Court of Federal Court of Australia.
In another setback to Big Pharma, US drug major Eli Lilly's blockbuster erectile dysfunction drug Cialis (generic name:Tadalafil) has failed to qualify for a product patent in India after the basic constituent of the medicine was found to be a known substance, developed and patented by Indian scientists 32 years ago.
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