After meningitis cases, FDA inspects pharma plant

Reacting to MiD DAY's report about 11 meningitis cases due to anaesthetic drug Bupivacaine given at civic-run hospitals, FDA scrutinised drug manufacturer Ciron Pharmaceuticals' plant 

After MiD DAY's expose on 11 patients who contracted meningitis after being administered local anaesthetic drug Bupivacaine at three civic hospitals, the Food and Drug Administration (FDA) has inspected the manufacturing plant of Ciron Pharmaceuticals, which supplies the drug to the hospitals. It is also collecting Bupivacaine samples from the facilities for testing them.

MiD DAY report yesterday

Civic doctors said they were shocked over the apathy of the administration. "Even if there was the slightest of doubt about the anaesthetic, the BMC hospitals should have stopped the drugs, instead of waiting for 11 patients to get meningitis," said a senior doctor requesting anonymity.

They also claimed they were compelled to use the drug despite having doubts as a circular from the director's office prohibited them from prescribing it from pharmacies outside. After two cases of meningitis surfaced from Sion hospital, the doctors suspected that the drugs had a role to play in the infection and alerted the FDA, which checked the drugs and gave it a clean chit.

K B Shende, joint commissioner, FDA (drugs), said, "Sion hospital had given us the drugs for examination earlier. After testing them, 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."

However, when Sion, Bhabha and KEM hospitals reported cases of post spinal meningitis (contamination in the body while administration of the anaesthetic) even after FDA's clean chit, they should have immediately stopped using it, doctors opine.

The other side
Dr Sanjay Oak, dean of KEM hospital and director of major civic hospitals, was unreachable for comment.
Rajul Patel, health committee chairman, BMC, said, "We will initiate an inquiry. Doctors and the drug's manufacturing company will have to answer." Kirti Shah, director, Ciron pharmaceutical, said, "We are cooperating with the FDA in their investigations."

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