India’s drug regulator has approved 31 fixed-dose combination (FDC) drugs out of more than 300 banned products, after an assessment by its drugs technical advisory board. It has also asked for more phase IV postmarketing data for 19 others.
The use of voice recognition systems based on artificial intelligence (AI) in health care is emerging in India, which offers a potentially enormous market, according to Scribetech Healthcare (India) Pvt. Ltd., one of the leading voice recognition companies in the country.
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18.
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18.
A new rule published by India’s Central Drug Standards Control Organization that would require additional tests, trials or even approvals for drugs after changes in their active substances is likely to have only limited impact on companies and the market, despite evoking memories of a bruising patent dispute eight years ago.
The Make in India initiative will be a long-term driver of local medical device manufacturing and will boost exports as well as a production linked incentive scheme, according to a report by market research firm Fitch Solutions.
A new rule published by India’s Central Drug Standards Control Organization that would require additional tests, trials or even approvals for drugs after changes in their active substances is likely to have only limited impact on companies and the market, despite evoking memories of a bruising patent dispute eight years ago.
Zydus Cadila Group could make history after applying for approval for the first ever human DNA vaccine in India. But that could be just the start for a technology that could treat a vast array of diseases, including cancer, infectious diseases and chronic diseases.
Zydus Cadila Ltd. has applied for emergency use authorization in India for its DNA plasmid COVID-19 vaccine, potentially the first shot of its kind to be approved in humans. The filing for the vaccine called ZyCoV-D will be based on a phase III study showing efficacy of 66.6% for symptomatic disease and 100% efficacy for moderate disease.
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.