Covid-19 has been pushing the limits of science and regulatory processes. Pharmaceutical companies are at phase 3 trials around the world, while the UK green-lighted emergency-use authorisation (EUA) of the Pfizer vaccine in early December.
On November 17, the US Food and Drug Administration (FDA) said that reviews of all data and information regarding EUAs granted to Covid-19 drugs and vaccines would be made public. “Today’s transparency action is just one of the number of steps we are taking to ensure public confidence in our EUA review process for drugs and biological products, especially any potential Covid-19 vaccines,” said USFDA Commissioner Stephen Hahn in a statement published by Reuters.
Around the same time in November, two of India’s largest clinical trials—being conducted by Pune-based Serum Institute of India (SII) and Hyderabad-based Bharat Biotech—came under scrutiny when one volunteer each from both trials were hospitalised after being administered a vaccination dosage. Although Union Secretary of Health and Family Welfare Rajesh Bhushan assured that these developments would not affect vaccine timelines in India, experts think pharma companies and the Drugs Controller General of India (DCGI) should be more transparent and accountable about explaining how evidence is being examined and decisions are being taken with respect to these procedures.
Denne historien er fra January 01, 2021-utgaven av Forbes India.
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Denne historien er fra January 01, 2021-utgaven av Forbes India.
Start din 7-dagers gratis prøveperiode på Magzter GOLD for å få tilgang til tusenvis av utvalgte premiumhistorier og 9000+ magasiner og aviser.
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Home-Cooked Meal Is Now Greatly Valued
The pandemic has also brought with it an improved focus on hygiene, use of technology in dining, rise of cloud kitchens and resurgence in popularity of Indian ingredients
Paytm 3.0 - Reaching Near Breakeven In Two Years
As of 2020, Vijay Shekhar Sharma’s super app for financial services had run up losses in thousands of crores. Now, as digital payments gets yet another boost courtesy Covid-19, he’s hopeful of reaching near breakeven in two years
THE PANDEMIC HAS CAUSED WOMEN GREATER LABOUR PAIN
Covid-19 has shown that women are more likely to face the brunt of job losses than men, and find fewer opportunities when they want to resume. That apart, several have to deal with increased hours of unpaid work at home and even domestic abuse
LEADERSHIP WILL BE ABOUT SEEING THE BIGGER PICTURE
Leaders must not only guard their teams first during a crisis, but also deal with stakeholders with respect and dignity. And apart from pursuing business goals, they should remain committed to our planet and the environment
PHILANTHROPY SHOULD BE HUMBLE, BUT NOT MODEST
Apart from building a flexible and resilient framework for the future, philanthropists, civil society and the government must work in tandem so that every rupee is absorbed on the ground
INTEGRATED HEALTH CARE, TECH WILL DISRUPT SECTOR
While clinical research will get a boost, having a skilled workforce and public spending on health care will be challenges in the near term
DIGITALISATION WILL HELP IN VALUE CREATION
As the pandemic brings technology and innovation to the core of business and daily life, the next decade will see about 150 million digital-first families in India
Industry 4.0: Climate Revolution?
Augmenting sustainability alongside digital capabilities is an economic, competitive and global opportunity for India’s businesses, but regulations need to reflect intent
EV Dream Still Miles Away
Electric vehicles have remained a buzzword in India for years. But not much has moved on ground due to high upfront costs, range anxiety and charging infrastructure
Living Waters
A virus has caused us to scramble for oxygen but our chokehold on the environment is slowly strangling the very waters that breathe life into us. The virus is a timely reminder: We are merely consumers, not producers of life’s breath on this planet