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HindustanTimes Sat,20 Sep 2014

Infant's death: vaccine vial has two expiry dates

Vishav Bharti, Hindustan Times  Chandigarh, April 26, 2013
First Published: 09:52 IST(26/4/2013) | Last Updated: 09:54 IST(26/4/2013)

A complete batch of Easyfive, a vaccine following the administration of which a one-and- a-half-old baby passed away at the Advanced Paediatrics Centre (APC) of the Post Graduate Institute of Medical Education and Research (PGIMER) on Tuesday, bears two different expiry dates.

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There is a gap of one year in both the expiry dates mentioned on the vials of the vaccine.

A vial from the same batch, which is in HT's possession (see picture), bears two-expiry dates -- March 2014 and March 2013.

The original label on the vial bears expiry date of March 2013. However, another sticker seemed to have been pasted over the original label, which has the expiry date of March 2014. 

The stockiest of the company in the city -- National Pharmaceuticals, Manimajra, also confirmed that the company has recalled the entire batch of the vaccine. “We have received a letter from the company and have also started collecting the stock from the market,” said BS Bawa, owner of National Pharmaceuticals.

However, when asked how one batch of vaccine can bear two different expiry dates, the company officials said they cannot comment as of now. “The matter is under investigation and we will come out with a comprehensive official response,” said PD Karan, general manager, corporate communications, Panacea Biotec.

The company is one of the biggest vaccine manufacturers in the country.

The infant born to a woman from Hallomajra died at APC on Tuesday after he was vaccinated. The doctors are suspecting death due to adverse affect of the vaccine.

It also raised suspicion among doctors as the baby died within 24 hours he was administered the vaccine. Following the death, the UT drug controller had also sealed the stock of the vaccine lying with the shop that had sold it.

According to PGIMER doctors, the cause of death couldn't be confirmed as the family has refused to go for autopsy of the baby.

Easyfive-TT, which is manufactured by Panacea Biotec, is a combination of five different vaccines. It prevents children from diseases like Hepatitis-B, Diphtheria (an upper respiratory tract illness), Tetanus, Pertussis (whooping cough), Hib (for protection from pneumonia).

Expertspeak
“Generally, the expiry date of any medicine is never extended. Vaccine is a very sensitive part of medicine. Expiry date of any vaccine should not be extended and if it is required to be extended, all tests have to be repeated to examine potency, toxicity etc.,” said Dr Rakesh Sehgal, former director, Central Research Institute (CRI), Kasauli.
 
DGCI team to probe matter
Sources in the UT health department said, an independent team of the drug control general of India (DCGI) is going to conduct an inquiry in the entire issue. The UT drug controller on Wednesday collected the information about batch of the vaccine and sealed the batch. The UT officials said they acted as per the World Health Organisation guidelines on vaccination.

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