Quality issues not behind sight loss in off-label Avastin use in India


Roche has checked a batch of Avastin (bevacizumab) in India linked to partial loss of sight for 15 patients and did not find any quality-related issues, though it repeated that the off-label use of the drug to treat age-related macular degeneration is not approved.

The Swiss-based firm conducted an internal inquiry, according to swissinfo.ch, after doctors in India administered eye injections of the oncology drug for the off-label use, citing lower cost. India initially put an alert on the drug after the incidents in the western state of Gujarat.

But the alert has since been withdrawn after the Drug Controller General of India (DCGI) accepted an expert committee report that safety and efficacy use for eye injections was demonstrated in "over 2,500 independent studies published globally and that it is 40 times cheaper than the other available drug for the same use."


The 13th Annual Digital Pharma East

Digital Pharma East returns to the Pennsylvania Convention Center September 17–20, bringing together over 1000 attendees from biotech and pharma, to better understand how to present business plans, justify budget and innovation, and de-risk proposals getting shut down — essentially, understand how they can return to the office and become champions for their internal digital needs. Join us and save 15% on standard rates when you register with Discount Code DPE19Fierce.

"In India, Roche has completed an assessment of the available information on the batch reported to have been used at C.H Nagri Eye Hospital in Ahmedabad, Gujarat. We can confirm that based on the information available, there is no reason to believe there were quality problems with the Avastin (Bevacizumab) vials in this batch," the company told swissinfo.ch.

While the alert has been lifted, Roche repeated that it did not in any way endorse use for age-related macular degeneration.

"We would like to reiterate that Avastin has not been approved for use in the eye by the U.S. FDA, EMA or the Government of India. Furthermore, it is not developed and manufactured to meet industry standards for intraocular injection solution," Roche told swissinfo.ch, adding that the risk of bacterial contamination was heightened in eye injections.

Some Indian doctors however have continued to use the therapy over Lucentis (ranibizumab), which is approved for age-related macular degeneration, but that costs significantly more than Avastin.

- here's the story from swissinfo.ch

Photo courtesy of Creative Commons--McKay Savage.

Suggested Articles

Leading Indian drugmakers Sun Pharma, Cipla, Aurobindo and Dr. Reddy's are all trying to expand their presences in China.

Hanmi loses Janssen obesity pact, while Yuhan signs NASH deal with Boehringer. GSK sells a Chinese site to Fosun as it opens facilities in Singapore.

Even as GlaxoSmithKline has opened its most advanced manufacturing site in Asia, it is selling an older plant in China to Fosun Pharma.