A key lesson for the pharmaceutical sector in this case is to not downplay the significant impact that regulatory non-compliance can have on operations.
'Pfizer India has submitted an application on December 4 to the DCGI seeking emergency use authorization for its COVID-19 vaccine in India'
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
Ajit Mishra, vice president, Research, Religare Broking, answers your queries.
Earlier in April, Pfizer said that it had offered a not-for-profit price for its vaccine for the government immunisation programme in India and it remains committed to continuing engagement with the government to make the vaccine available in India.
Pfizer Ltd, the Indian arm of the world's largest pharmaceutical company Pfizer Inc, is selling four consumer health brands that are household names in India Listerine, Benadryl, Caladryl and Benylin to Johnson & Johnson Ltd for Rs 214.85 crore, as part of J&J's acquisition of Pfizer's global consumer health business in June 2006.
Currently, the country is using two 'made-in India' jabs -- Covishield and Covaxin -- to inoculate its billion-plus population and has administered 20 crore doses since launching the world's largest vaccination drive in mid-January. A third vaccine, Russian-made Sputnik V, has been approved by the government and is being used on a smaller scale at present.
As India gets ready to roll out one of the largest vaccine programmes, billionaire Mukesh Ambani on Tuesday said his group is working with authorities to provide technology tools and backbone for mass inoculation against COVID-19. Ambani's telecom venture Jio was rolled out four years back, offering free voice calling and dirt-cheap data. Today, Jio is India's largest telecom operator with over 400 million users, each connected to the internet. At a Facebook event, Ambani said the government's digital push kept the country running even during the pandemic and is now helping in the rollout of one of the largest vaccination programmes.
In the international market, Pfizer completed its acquisition of Wyeth in 2009.
Aurobindo Pharma, Cadila Healthcare and Serum Institute are readying their vaccine candidates.
Voveran, Novartis India's flagship pain killer medicine, has become the largest selling domestic drug with sales of more than Rs 11 crore (Rs 110 million) in March 2008, displacing Pfizer India's cough and cold syrup Corex, which had sales of Rs 10 crore (Rs 100 million). Cipla, on the other hand, maintained its leadership position as the largest domestic pharmaceutical company edging out Ranbaxy Laboratories with a market share of 5.24 per cent.
Pfizer Ltd has said that its US parent company has nominated Kewal Handa as managing director of the company.
The next hearing on Pfizer's plea is slated for March 21
India battles big pharma over cough syrup abuse, reducing supplies