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Pakistan: Substandard eye injections cause vision impairment in people

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Pakistan said on Monday 25th September it was investigating two local distributors of Swiss pharmaceutical company Roche (ROG.S)'s Avastin cancer drug after 12 diabetic patients injected with the drug went blind.

The Drug Regulatory Authority of Pakistan (DRAP) said the health authorities in Punjab, the most populous province, had launched the investigation into local use of the drug Avastin, which is licensed for use in Pakistan.

"Incidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection," the regulator said in a statement.

Javed Akram, the province's minister for Specialized Health, said police were questioning two men they believe to be the drug's distributors in the state.

Following the incidents, the DRAP instructed the importer to recall the suspected batches of Avastin 100mg injection, which it said had been created illegally.

"The sale/distribution of registered Avastin Injection has been put on halt till verification of its quality through sampling and laboratory testing to safeguard public health," it said in a statement on its website.

On its website, Roche said Avastin was approved in more than 130 countries, including the United States, to treat several types of cancer. Roche's Pakistan spokesman did not answer several calls.

Avastin was used as an eye treatment off-label, meaning outside of the approved use. Cancer drug Avastin, when used at much lower doses, is similar to eye drug Lucentis, and is used in many countries as a low-cost option to treat certain blindness-causing conditions.

Alam Sher, Punjab's deputy drug controller who filed the police complaint against the distributors, told Reuters that some companies buy Avastin and repackage it in smaller doses to make it more affordable for patients.

A sharp drop in the value of the local currency against the U.S. dollar has inflated the price of drugs in Pakistan, many of which are either imported or based on imported ingredients. Record high inflation has also diminished the purchasing power of many people.

Source: Reuters
 
The Punjab government has decided to increase the number weekly holidays in schools across the province in the wake of the spread of conjunctivitis.

The development came when the caretaker Chief Minister Mohsin Naqvi visited a school on Ravi Road in Lahore, where students complained about lack of illumination and fans in the building.

However, the CM also found that students afflicted with pink eyes were present in classrooms.

Naqvi immediately summoned the Secretary of Schools over lack of adherence to conjunctivitis guidelines. He also ordered that students in all government and private schools should be given Thursdays and Saturdays off.

Source: AAJ News
 
Pakistan said on Monday 25th September it was investigating two local distributors of Swiss pharmaceutical company Roche (ROG.S)'s Avastin cancer drug after 12 diabetic patients injected with the drug went blind.

The Drug Regulatory Authority of Pakistan (DRAP) said the health authorities in Punjab, the most populous province, had launched the investigation into local use of the drug Avastin, which is licensed for use in Pakistan.

"Incidents of loss of vision in diabetic patients have been reported following treatment with Altered/Dispensed/Diluted Avastin injection," the regulator said in a statement.

Javed Akram, the province's minister for Specialized Health, said police were questioning two men they believe to be the drug's distributors in the state.



Avastin was used as an eye treatment off-label, meaning outside of the approved use. Cancer drug Avastin, when used at much lower doses, is similar to eye drug Lucentis, and is used in many countries as a low-cost option to treat certain blindness-causing conditions.

Alam Sher, Punjab's deputy drug controller who filed the police complaint against the distributors, told Reuters that some companies buy Avastin and repackage it in smaller doses to make it more affordable for patients.



Source: Reuters
An off-label usage basically means that Pakistan cannot sue Roche for damages. Assuming of course, that the label documents were clear, and approved by the Pakistan authorities.

Alam Sher, Punjab's deputy drug controller who filed the police complaint against the distributors, told Reuters that some companies buy Avastin and repackage it in smaller doses to make it more affordable for patients.

Depending on what's in the label documents, re-packaging could amount to off label usage as well.

The worst sufferers will be the affected victims, sadly. Everyone else will get off the hook clean.
 
Investigations into the Avastin injection scam have revealed significant revelations that Avastin continued to be used despite the availability of registered injections for eye treatment.

According to the details, the sources have revealed that 2 drugs are registered for the treatment of the disease called retinal vein occlusion, which include injections called Lucentis and Eylea.

According to Drape sources, the price of Lucentis injection is 1 lakh, and the price of Ilia injection is 33 thousand Pakistani rupees.

The disease of blood clotting in the arteries of the eye is called retinal vein occlusion, for the treatment of which injections called Lucentis and Ilia are easily available across the country, but doctors and hospital administration used to save more on the use of Avastin injection. And doctors continued to use Avastin illegally for money.

Source: ARY
 
It has been decided to lift the ban on the use of Avastin injection, which causes loss of vision, and the recall alerts of Avastin medicine have been cancelled.

According to the details, the Punjab government has decided to lift the ban on the use of Avastin injection, sources said that the Punjab government has canceled the Avastin medicine recall alerts and has approved the release of 4 batches of Avastin.

Sources said that the Punjab Quality Control Board, High Power Committee approved the batch release, the Punjab Drug Control Directorate also issued an Avestin recall cancellation alert.

Sources have said that cancellation alerts have been issued for distributors, wholesalers, retailers, doctors, Drug Testing Lab Lahore has declared 4 batches of Eosin Injection as standard.

Three batches of Avastin 100 mg and one batch of 400 mg have been declared usable, after which distributors, wholesalers, retailers have been instructed to ensure Avastin protocols, saying that doctors must ensure the implementation of protocols required for applying Avastin. Will make.

Source: ARY
 
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