Friday, June 30, 2023

Lethal exports.

US Food and Drug Administration (FDA) "Auditors uncovered 'deficient' manufacturing cleaning and storage controls during a visit to an Aurobindo Pharma Ltd facility at Anakapalli, eastern India, according to a FDA report obtained by Bloomberg News." DH. "Sampling tools weren't cleaned and maintained to prevent contamination at the plant, which produces certain active pharmaceutical ingredients - the raw materials core to making drugs. Laboratory controls also didn't include the establishment of scientifically sound and appropriate specification, designed to assure that drug products conform to appropriate standards of identity, quality and purity, the report said." If this is what they are selling to the US, imagine what they must be selling to Indians? "On June 1, Intas Pharmaceuticals received communication from the US FDA stating that the company's manufacturing facility in Ahmedabad - Special Economic Zone (Pharmez) near Matoda - has been listed under import alert." Forbes. "A section of the Indian pharma sector suggests, off the record, that the increasing regulatory scrutiny could have something to do with US Big Pharma lobbying against Indian generic manufacturers." American Atmanirbhar? In 2022, "Mumbai-based drug major Lupin's regulatory woes don't seem to be ending this year. After being issued two Form 483s by the US FDA to the Pune and Nagpur plants in October, a warning letter was also issued to the Tarapur facility recently." ET. Lupin is a major manufacturer of drugs against Tuberculosis (TB). Lupin. "India's TB incidence for the year 2021 is 210 per 100,000 population - compared to the baseline year 2015 (incidence was 256 per 100,000 of population in India); there has been an 18% decline which is 7% percentage points better than the global average of 11%." PIB. 210 per 100,000 comes to a total of 2.94 million patients in a population of 1.4 billion Indians. Any lapse at Lupin could have dire consequences for the nation. Contaminated drugs can kill and contaminated medicines from India have killed innocent babies in other countries. "The Indian manufacturer of cough syrups that Uzbekistan said last year had poisoned 19 children used a toxic industrial- grade ingredient rather than the legitimate pharmaceutical version, two sources with knowledge of the matter told Reuters." DH. Before that, 70 children were killed in the Gambia by cough syrups from India which contained ethylene glycol and diethylene glycol. wikipedia. In 2021, at the height of the Covid pandemic, patients developed chills, shivering and high fever when given Remdesivir infusions in hospitals across North India. "Only the Bihar regulator identified the cause of the mysterious illness. Their testing found Cadila's batch V100167 to contain bacterial endotoxins - compounds present in the preotective envelopes of bacteria, which cause fever, chills and life-threatening septic shock in humans," wrote Priyanka Pulia. Who cares? Just deny. Just as over 4 million people did not die of Covid. ET. Indians are cheap. Others beware.

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