Telengana joins Gujarat in halting sales of Roche's Avastin

Telengana has joined Gujarat in putting sales of drug major Roche's cancer treatment drug, Avastin, on hold after 15 patients lost their vision partially after using it in Ahmedabad.
Telangana Drug Control officials today started "freezing" the company's blockbuster drug, Avastin, based on information that it received from its Gujarat counterparts saying that the drug has allegedly hampered vision for some patients who had usedit, a senior official of the Drug Control Administration the state said.
"We have received information that the drug caused some vision problems to patients in Gujarat. As a precautionary measure we started freezing the samples of Avastin. It is not made in India. It is imported into the country," MAmruth Rao, Deputy Directorof DCA, told PTI.

A senior official of the department said they have also started identifying the licensed importers of the drug. The official said the sample will be sent to laboratory for verifying the standards.
On January 14, the sales of drug were put on hold in Gujarat.
"We have asked the Switzerland-based drug manufacturing company H Hoffmann-La Roche Ltd and importer company in Mumbai Roche product (I) to put on hold the sale of Avastin injections of that batch number," Gujarat Food and Drug Control Administration(FDCA) Chairman H G Koshia said.

"We have not banned the drug yet but as the hospital authorities suspect that the problem came up after they were given Avastin injections, as a precautionary measure we have asked the company not to sell this batch of the drug in the market," he said.

Koshia said authorities had collected two-three samples of the same batch for testing. "As it is an injection, it will take 10 to 12 days to find out if the drug was contaminated."
Meanwhile, some of the 15 patients who complained of partial vision loss were operated upon by doctors on January 13 and 14.
These patients were undergoing treatment for various eye ailments at the civic-run C H Nagri Eye Hospital in Ahmedabad.
Commenting on the development, a Roche India spokesperson said: "Our carrying and forwarding agent in Hyderabad has received a communication to hold salesfor a period of 20 days. We have also received communication from the Deputy Commissioner, FDA Gujarat, requesting for supply details of a specific batch of Avastin and technical testing protocols."

Patient safety is always Roche's primary concern, and as such, "We are taking the events in Gujarat very seriously. Roche will co-operate fully with any investigations undertaken by the authorities.We have also initiated an internal investigation.