Biosimilars are bearing the brunt of the impact that COVID-19 has had on the U.S. FDA’s inspection program, which has ground almost to a halt during the pandemic. That’s the message Juliana Reed, president of the Biosimilars Forum, delivered to a House subcommittee last week.
China’s med-tech products exports declined in 2021 as manufacturing in other countries picked up, while med-tech imports to the country increased. In the first half of 2021, China’s med-tech exports amounted to $47.931 billion, a decrease of 23.1% year-on-year. But imports for the same period amounted to $24.392 billion, an increase of 25.2% year-on-year, according to med-tech data company Guangzhou Joinchain Big Data Technology Co. Ltd.
India’s Department of Pharmaceuticals (DOD) released draft guidelines to boost research and development in its pharmaceutical and medical device industries. The document touched on the reasons for a dedicated R&D and innovation policy, which involved reducing import dependence, increasing the speed of biologic and biosimilar development cycles, and tackling infrastructural challenges.
India’s Department of Pharmaceuticals (DOD) released draft guidelines to boost research and development in its pharmaceutical and medical device industries. The document touched on the reasons for a dedicated R&D and innovation policy, which involved reducing import dependence, increasing the speed of biologic and biosimilar development cycles, and tackling infrastructural challenges.
Even as it strives for self-reliance, India is struggling to wean itself off a reported 75% increase in med-tech imports from China. China led the contribution to India’s med-tech imports with ₹91.12 billion (US$1.2 billion) worth of goods in the 2021 fiscal year (April 2020 to March 2021), according to an analysis of data from India’s Department of Commerce by the Association of Indian Medical Device Industry (AIMED).
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).
