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After falsely blaming Indian cough syrups for deaths of children in Gambia, US FDA now directly takes a shot at India-made eye drops for infections, blindness and one death.
They say Indian eyedrops led to outbreak of drug-resistant bacteria causing adverse events.
#Thread
They say Indian eyedrops led to outbreak of drug-resistant bacteria causing adverse events.
#Thread
1. Accusation by US FDA
Agency say that the Artificial Tears eye drop manufactured by the India firm has a potential bacterial contamination and that the company has violated good manufacturing practices.
Agency say that the Artificial Tears eye drop manufactured by the India firm has a potential bacterial contamination and that the company has violated good manufacturing practices.
2. US CDC testing result
• US laboratory which conducted the testing identified presence of the outbreak strain in some OPENED bottles.
• Testing of UNOPENED bottles will assist in evaluating whether contamination occurred during manufacturing process.
• US laboratory which conducted the testing identified presence of the outbreak strain in some OPENED bottles.
• Testing of UNOPENED bottles will assist in evaluating whether contamination occurred during manufacturing process.
2. Reaction by Indian Manufacturer
• Global Pharma Healthcare which is based in Chennai has issued a VOLUNTARTY RECALL of all unexpired eye drops.
• These eye drops are only for sale and distribution in the United States.
• Global Pharma Healthcare which is based in Chennai has issued a VOLUNTARTY RECALL of all unexpired eye drops.
• These eye drops are only for sale and distribution in the United States.
3. Global Pharma Deny FDA allegations.
• Manufacturer say their products had a safety seal top and were not associated with customer cases
• They also pointed out that FDA has not provided any evidence of testing that "definitively links" bacterial outbreak to their product.
• Manufacturer say their products had a safety seal top and were not associated with customer cases
• They also pointed out that FDA has not provided any evidence of testing that "definitively links" bacterial outbreak to their product.
4. Reaction of Indian authorities
• Indian officials say that US federal and state drug regulators are visiting the manufacturing plant near Chennai to carry out check on manufacturing process.
• Currently the drops are not sold in India.
• Indian officials say that US federal and state drug regulators are visiting the manufacturing plant near Chennai to carry out check on manufacturing process.
• Currently the drops are not sold in India.
5. Past allegations on India pharmaceutical companies.
• Since October last year, this is the third Indian pharmaceutical company accused of link with mass casualties or adverse events in other countries.
• Note : none of the accusation have been proven.
• Since October last year, this is the third Indian pharmaceutical company accused of link with mass casualties or adverse events in other countries.
• Note : none of the accusation have been proven.
6. WHO vs Indian authorities.
• WHO only shares incomplete lab reports with Indian authorities.
• Both WHO and India authorities have been involved in many public iterations ever since this controversy erupted in October over various issues.
• WHO only shares incomplete lab reports with Indian authorities.
• Both WHO and India authorities have been involved in many public iterations ever since this controversy erupted in October over various issues.
7. Even India’s health minister, Mansukh Mandaviya says the report by WHO is an attempt to ruin India’s image.
“[It is a] bid to sully India’s tag as pharmacy of the world.”
“[It is a] bid to sully India’s tag as pharmacy of the world.”
8. Indian generics medicines are a dominant player in the world with about 40% volume share in the US market and about 20% globally.
India is the largest international provider of generic drugs which are much cheaper & with similar brand name as original expensive drugs.
India is the largest international provider of generic drugs which are much cheaper & with similar brand name as original expensive drugs.
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