U.S. trading partners are raising concerns about the FDA’s continued delays in inspecting foreign drug manufacturing facilities due to the COVID-19 pandemic and related travel restrictions.
India is home to just one of several regulatory entities that have overhauled their med-tech regulatory apparatus in recent years, but the Central Drugs Standard Control Organization (CDSCO) has also joined the COVID-19 regulatory delay club as well.
The COVID-19 pandemic has pushed India’s pharmaceutical and medical device industries towards the more widespread use of blockchain as part of a significant digital transformation effort underpinned by growing use of the Internet of Things (IoT), machine learning (ML) and the use of artificial intelligence (AI).
Through a series of notifications, India’s drug regulator has classified a new batch of medical devices as well as a range of software used in medical devices according to risk, taking another step to strengthen regulatory oversight and shore up the domestic med-tech sector.
The COVID-19 pandemic has pushed India’s pharmaceutical and medical device industries towards the more widespread use of blockchain as part of a significant digital transformation effort underpinned by growing use of the Internet of Things (IoT), machine learning (ML) and the use of artificial intelligence (AI).
India is turning to digital means in a bid to manage illnesses within its borders, with both public and private corporations getting in on the action. The All India Institute of Medical Sciences Delhi (AIIMS), a public medical institute in the state of Delhi, has developed two mobile apps for patients with chronic mental illness and their caregivers. The first app is Shaksham, for patients with chronic mental illness, while another, called Disha, will be for patients who are undergoing their first such episode of symptoms.
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.
