India’s CDSCO Warns Against Using Roche’s Avastin as Eye Treatment

Posted 21 January 2016 By Zachary Brennan

placeholder+image

India’s Central Drugs Standards Control Organization (CDSCO) issued an alert Thursday notifying state and local authorities that Roche’s blockbuster drug Avastin has not been approved to treat any ophthalmology conditions and can lead to vision loss.

The notice comes just two days after officials in two Indian states put sales of the cancer drug on hold after injections of the drug damaged the vision of 15 patients in the western state of Gujarat.

According to Reuters, H.G. Koshia, the top drug controller in Gujarat, said that he directed distributors to recall one batch of Avastin given to patients last week and samples of the drug were being tested following the incident at a hospital in Ahmedabad city.

“In view to safeguard the public health and as a precautionary measure, all concerned are hereby directed that the drug is not used in ophthalmology and the State/UT regulatory authorities may alert their inspectorate staff to monitor the movement of the said drug and its use for ophthalmology purposes,” G.N. Singh, Drugs Controller General of India, said in the alert Thursday. 

The Indian state of Telangana also ordered a freeze on all batches of Avastin being sold in the state, according to one official.

"Roche will cooperate fully with any investigations undertaken by the authorities,” the company said in a statement. “We are taking the events in Gujarat very seriously." 

Back in June, Roche announced its opposition to using Avastin to treat wet age-related macular degeneration (AMD), for which it is not approved by the US Food and Drug Administration.

After Avastin was approved in the US and Europe for other indications more about a decade ago, it has been used off-label to treat AMD. However, Lucentis in 2006 became the first authorized drug indicated to treat AMD, and Novartis has explained the differences between the two drugs.

But because Lucentis costs about 30 times more than Avastin, and the two drugs are thought to be similarly effective, several prominent health authorities—including the World Health Organization (WHO), the International Council of Ophthalmology (ICO) and the National Eye Institute (NEI)—have supported using Avastin to treat AMD.

DCGI Alert

Share this article:

Categories: Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance, News, India, CDSCO

Tags: Avastin, Roche, Novartis, Lucentis, Genentech, CDSCO

Regulatory Exchange: Latest Updates From the Community