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US FDA Flags Lapses by Indian Firm's Eye Drops Linked to Vision Loss and Deaths - Tabassum Barnagarwala

Scroll.in The US Food and Drug Administration has found a series of violations in the manufacturing process and sterilisation methods adopted by Global Pharma, the Indian manufacturer of an eye drop that has been linked to 68 cases of eye infection in America, including eight cases of vision loss and three deaths. The company recalled its product, EzriCare Artificial Tears Eye Drop, early in February. The over-the-counter product has been linked to...

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Maharashtra FDA recalls batch of anti-anaemic medicine after alleged cases of adverse reactions

-Scroll.in One persons died in Mumbai after allegedly being administered with Orofer FCM. The Maharashtra Food and Drug Administration has announced that it will recall a batch of anti-anaemic medicine Orofer FCM after noting multiple incidents of alleged adverse reaction, including the suspected death of a 55-year-old man in Mumbai in September. Orofer FCM is manufactured by Pune-based Emcure Pharmaceuticals, which supplies medicines to 70 countries. It is administered in the form of...

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For Poor Manufacturing Practices, Indian Pharma Company Gets ‘Warning Letter’ From US FDA

-TheWire.in The US drug regulator says Lupin Limited's response to tackling genotoxic impurities was not adequate. New Delhi: The US Food and Drug Administration (FDA) has sent a warning letter to the Indian pharmaceutical company Lupin Limited after deeming its efforts to address violations of various good manufacturing practices at its facility in Tarapur, Maharashtra “inadequate”. The FDA sends a ‘warning letter’ to a manufacturer if it has “significantly violated” the agency’s regulations....

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India learns a bitter lesson for disregarding crucial warnings and recommendations on Covid-19

In the month of April this year, there has been an unprecedented upsurge in daily new cases and daily new deaths in the country due to Covid-19. States, which reported large increases in daily new cases and daily new deaths, are Maharashtra, Kerala, Karnataka, Delhi and Uttar Pradesh, to name but a few.   Data accessed from https://www.covid19india.org/, which is a crowdsourced platform and an independent aggregator of daily Covid-19 figures and...

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Cheap generic vs costly branded: Issues in picking right drug in India -Kaunain Sheriff M

-The Indian Express Prime Minister Narendra Modi wants doctors to prescribe generic medicines over branded ones. KAUNAIN SHERIFF M answers key questions on the pricing of drugs and beyond. * What exactly has Prime Minister Narendra Modi said on generic drugs? Speaking in Surat on April 17, the Prime Minister referred to the Pradhan Mantri Bharatiya Janaushadhi Pariyojana (PMBJP), which aims to provide cheaper medical drugs to the people. “In the coming days,...

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