While two Indian states have put sales of Swiss drug maker Roche’s blockbuster drug Avastin on hold after reports of partial loss of eyesight among patients emerged, the country’s apex drug regulator has ordered state drug controllers to collect samples of the drug for testing from the across the country.
Usage of Avastin reportedly led to partial loss of eyesight in 15 patients in Gujarat, following which the southern state of Telangana ordered a freeze on all batches of the drug being sold in the state.
“It is an alarming issue. I have sent alerts to state drug controllers to investigate the matter and I have also ordered collection of Avastin’s samples pan-India. We have also seized the batch of drugs and have sent a notification across India to monitor the usage of Avastin,” GN Singh, drug controller general of India told HT.
For about 20 days, sale for the drug has been halted in Gujarat and samples have been sent for testing. The report is expected in two weeks. “If the report signals any loophole in the manufacturing process or negligence on the part of the company, we will order an inspection and audit at company’s manufacturing units,” Singh said.
Roche has entered into a licensing agreement with Curadev, a private Indian company, to develop small molecules in cancer immunotherapy, and stores its imported products at its facility in Mumbai.
Meanwhile, the drug maker has also initiated an internal investigation into the matter. “We are taking the events in Gujarat very seriously. Roche will cooperate fully with any investigations undertaken by the authorities. We have also initiated an internal investigation,” the company’s spokesperson said in an e-mail to HT.
Though doctors around the globe use Avastin to treat vision loss, it has not been approved by the US Food and Drug Administration for that purpose. Studies have shown that eye injections of Avastin check vision loss but the company does not claim to sell the drug for this specific purpose.
“We would like to highlight that Avastin has not been approved for intra-ocular use by the US FDA, EMA or the government of India. It is not developed and manufactured to meet intra-ocular standards. Adaptation of the product for use in this way is considered ‘off label’,” the spokesperson said.