Indian drugmakers have often found themselves in the sights of Western regulators who have instructed them to fix plants and recall products. Now in a turnabout, one of India’s drug regulators is having Sanofi recall a painkiller it says did not meet specifications.
Sanofi has recalled four batches of Combiflam after India’s Central Drugs Standard Control Organisation (CDSCO) found it was not meeting specifications for disintegration, Reuters reports. Combiflam, a combo of paracetamol and ibuprofen, is one of the French drugmaker’s top sellers in the country, the news service reports.
A Sanofi spokeswoman told DNA India that while there was no safety issue with the drug, it was being recalled since the CDSCO had deemed it substandard. "We have acted immediately and completed the recall for two batches, while the recall of the remaining two batches is ongoing," she said, adding that the company has already taken steps to rectify the problem.
Indian drugmakers have often found their products the subjects of recalls in the U.S. Wockhardt recalled more than 7 million products last year after several of its plants came under fire by the FDA. Just this week, Indian companies Dr. Reddy’s Laboratories ($RDY) and Akorn ($AKRX) both had recalls listed by the FDA. But so did U.S. drugmakers Mylan ($MYL) and Pfizer’s ($PFE) Hospira.