Contaminated Polio Vaccines: Ghaziabad pharma firm banned by Health Ministry
New Delhi: The Ministry of Health and Family Welfare said it has banned a Ghaziabad based pharmaceutical company after a probe traces of polio type-2 virus were found in some batches of oral polio vaccine (OPV) in last week.
The managing director of Ghaziabad-based Biomed Pvt Ltd., which was supplying polio vaccines for only government-run immunisation programmes, was arrested after the Central Drug Regulator filed an FIR in this case.
Read Also: Polio Vaccines Found Contaminated, Ghaziabad Pharma Company MD Arrested
The Drugs Controller General of India has also asked the company to stop "manufacture, sale or distribution till further orders."
Now the Health Ministry has banned the supply and manufacturing of the polio vaccine. "On investigation, it was found that in a few vials of bivalent Oral Polio Vaccine (bOPV) supplied by one manufacturer, there were traces of the P2 virus. Following the report, the use of all the vaccine supplied by this manufacturer was immediately stopped in the country till investigation was completed," a Ministry statement said on Wednesday.
According to the Ministry, additional legal samples of bOPV were immediately sent for testing to the Central Drug Laboratory in Kasauli, which confirmed the previous report of the presence of traces of the virus.
Polio type 2 virus strain has been eradicated worldwide, including in India.
According to a Health Ministry source, the contamination came to light after surveillance reports from Uttar Pradesh showed signs of the virus in stool samples of some children.
Immediately, the OPVs were sent for testing which confirmed that some of them were contaminated with a type-2 virus.
The ministry had also alerted the Uttar Pradesh and Maharashtra governments assuming a possible usage of the vaccine there.
The incident has come as a grave risk to the country, not only for its children but also to its "polio-free" status as children born after April 2016 —when the type 2 virus was withdrawn worldwide including in India — do not have immunity to this particular strain.
Last week, three batches of polio vaccines containing 1.5 lakh vials were reportedly found to be infected with type-2 poliovirus. However, in its statement, the ministry said that only "a few vials" of bivalent oral polio vaccine were found to contain traces of the P2 virus.
The Ministry stated that to enhance immunity against type 2-poliovirus further, special mop-up rounds for administering Inactivated Polio Vaccine (IPV) are being conducted in the specified areas to reach out to such children who may have missed IPV.
"The contamination can have very serious ramifications on public health because it is tantamount to reintroducing into the community a virus that had been eradicated. The WHO and health authorities are keeping a close watch for any active strain of the virus in stool samples or in sewage," a senior official said.
Read Also: Sanofi Pasteur Expired polio vaccines being used in Gujarat: Probe demanded
The managing director of Ghaziabad-based Biomed Pvt Ltd., which was supplying polio vaccines for only government-run immunisation programmes, was arrested after the Central Drug Regulator filed an FIR in this case.
Read Also: Polio Vaccines Found Contaminated, Ghaziabad Pharma Company MD Arrested
The Drugs Controller General of India has also asked the company to stop "manufacture, sale or distribution till further orders."
Now the Health Ministry has banned the supply and manufacturing of the polio vaccine. "On investigation, it was found that in a few vials of bivalent Oral Polio Vaccine (bOPV) supplied by one manufacturer, there were traces of the P2 virus. Following the report, the use of all the vaccine supplied by this manufacturer was immediately stopped in the country till investigation was completed," a Ministry statement said on Wednesday.
According to the Ministry, additional legal samples of bOPV were immediately sent for testing to the Central Drug Laboratory in Kasauli, which confirmed the previous report of the presence of traces of the virus.
Polio type 2 virus strain has been eradicated worldwide, including in India.
According to a Health Ministry source, the contamination came to light after surveillance reports from Uttar Pradesh showed signs of the virus in stool samples of some children.
Immediately, the OPVs were sent for testing which confirmed that some of them were contaminated with a type-2 virus.
The ministry had also alerted the Uttar Pradesh and Maharashtra governments assuming a possible usage of the vaccine there.
The incident has come as a grave risk to the country, not only for its children but also to its "polio-free" status as children born after April 2016 —when the type 2 virus was withdrawn worldwide including in India — do not have immunity to this particular strain.
Last week, three batches of polio vaccines containing 1.5 lakh vials were reportedly found to be infected with type-2 poliovirus. However, in its statement, the ministry said that only "a few vials" of bivalent oral polio vaccine were found to contain traces of the P2 virus.
The Ministry stated that to enhance immunity against type 2-poliovirus further, special mop-up rounds for administering Inactivated Polio Vaccine (IPV) are being conducted in the specified areas to reach out to such children who may have missed IPV.
"The contamination can have very serious ramifications on public health because it is tantamount to reintroducing into the community a virus that had been eradicated. The WHO and health authorities are keeping a close watch for any active strain of the virus in stool samples or in sewage," a senior official said.
Read Also: Sanofi Pasteur Expired polio vaccines being used in Gujarat: Probe demanded
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