Warnings on pentavalent jab sans mfg date were ignored

The latest batch of pentavalent vaccines that reached the state was not the only one which didn't have a valid manufacturing date printed on it.
Sources in the health department confirmed that during the past one year several batches of pentavalent vaccines without the valid manufacturing date were supplied to the state.
Shockingly, neither the drugs control department nor the health department initiated any action to stop the practice.Instead, they distributed the vaccines sans the manufacturing date to government hospitals across the state. It was during this period that suspected pentavalent deaths were reported in the state triggering a huge controversy. But the central expert committee had termed the vaccine as safe and had ruled out the possibility of the jab as the reason behind the alleged seven deaths of children in the state.
The pharmacists at the three regional centres where the vaccines were stocked -- in Kozhikode, Ernakulam and Thiruvananthapuram -- had reported this matter to the state health service directorate on several occasions in the past one year. Reports prepared by the pharmacists in charge of these storage centres were promptly sent to the directorate of health service.
"We had noticed that several batches of pentavalent vaccines had come to the state without marking manufacturing date. Any discrepancy in the label has to be brought to the notice of the authorities and hence we wrote this in the report submitted to the authorities. However no action was taken by them," said an official who had informed this to the authorities.
The issue was even brought to the notice of district drugs control department authorities several times. However, Dr N Sreedhar, additional director of health service, who is in charge of the immunization programme, said no such case was brought before him.
After the TOI expose on the issue, Sreedhar has now asked the district health administration authorities in Ernakulam and Kannur to give a report in this regard. But the health service authorities are of the view that since these vaccines are tested at the central drug testing laboratory at Kasauli before they are sent to Kerala, there was no need for any concern over the quality. Interestingly, only a few samples are tested in this lab and not the entire batch.
When asked why the state drugs control department did not take any action, a senior department official said, "The manufacturer of the vaccine enjoys a monopoly in the market and hence any move by us to send a notice would severely affect the immunization programme."
The latest batch of pentavalent vaccine reached the state was not the only batch which didn't have a valid manufacturing date printed on it. Sources in the health department confirmed that during the past one year, several batches of pentavalent vaccine which didn't have a valid manufacturing date had reached the state.
Shockingly, neither the drugs control department nor the health department initiated any action to stop the practice. Instead, they played complacent to distribute the vaccine without manufacturing date among government hospitals across the state. It was during this period that suspected pentavalent deaths were reported in the state triggering controversy. But, the central expert committee had termed the vaccine as safe and had ruled out the possibility of the vaccine as the reason behind the alleged seven deaths of kids in the state.
The pharmacists at the three regional centres where the vaccines were stocked, in Kozhikode, Ernakulam and Thiruvananthapuram had reported this matter to the state health service directorate on several occasions in the past one year. Reports prepared by pharmacists who are in charge of these storage centres had been promptly sent to the directorate of health service.
We had noticed that several batches of pentavalent vaccines had come to the state without marking manufacturing date. Any discrepancy in the label has to be brought to the notice of the authorities and hence we had written this in the report submitted to the authorities as soon as the stock of vaccines arrived here. However no action was taken by them,'' said an official who had informed this to the authorities.
Not just this even the issue was brought to the district drugs control department authorities several times. However, Dr N Sreedhar additional director of health service who is in charge of the immunisation programme said that no such cases was brought before him.
Following the TOI expose on the issue Dr N Sreedhar has now asked the district health administration authorities in Ernakulam and Kannur to give a report. But the health service authorities are of the view that since these vaccines are tested at the Central Drug testing Laboratory at Kasauli before it is sent to Kerala there was no need for any concern over the quality. But it is interesting that only a few samples are tested in this lab and not the entire batch.
But it is strange that how the state drugs control department did not take any action against the vaccines which had violated the drugs and cosmetics act. The manufacturer of the vaccine enjoys a monopoly in the market and hence any move by us to sent a notice would severely affect the immunisation programme,'' said a senior drugs control department official.