The drug regulator for Maharashtra has inspected the east Indian manufacturing plant of Ciron Pharmaceuticals, supplier of the anesthetic bupivacaine to hospitals, following the appearance of 11 cases of meningitis in patients who were administered the drug. The agency is also collecting samples of the drug from hospitals for testing, reports Mid-Day.
The U.S. FDA has clarified that its India Office had no knowledge of this case, nor any involvement in it, a spokesperson said via email.*
Doctors at state hospital Sion contacted the Maharashtra FDA after two patients developed meningitis following administration of the anesthetic, according to the report. The agency checked and found no problems, the story said.
"After testing [the drugs], we found them to be of standard quality. But now we have started a fresh investigation and we are looking at all possible causes of infection as well as contamination," the story quotes K B Shende, identified as a joint commissioner for the regulator, as saying.
Mid-Day says the action follows the newspaper's earlier report describing the 11 meningitis cases--those from Sion as well as two additional state hospitals: Bhabha and KEM. The cases developed over a 5-month period.
The earlier report said that two of the Sion hospital patients were in critical condition "but were pulled out of infection after rigorous antibiotic treatment."
Editor's Note: The story originally stated that the U.S. FDA had inspected the Ciron plant and that we had contacted the U.S. FDA for confirmation.