[2013] African Nodding Disease is Actually Vaccine-Induced Absence Seizures Pentavalent Mistakes (vaccine)
Expired vaccines enter city mkt, FDA clueless
By Mayuri Phadnis | Sep 14, 2013
The original label on the vial shows the expiry date as March 2013, while in the new label, it has been changed to 2014
As the country’s largest producer of the drug, Pune’s Serum Institute of India, drew the attention of the Supreme Court in a petition questioning the marketing and use of Pentavalent vaccine.
But a bigger scam of expired drugs being relabeled and sold by another vendor, Delhi-based Panacea Biotec, escaped the notice of both doctors and Food and Drugs Administration (FDA) in the city.
The controversial batch was quietly withdrawn after Central Drugs Standard Control Organisation in May. But not before a few of them reached the unwary consumers in the city.
Mirror accessed one such vial from a stockist on Friday, which sported two labels. The original one underneath had an expiry date of March 2013, while the overlapping one put the expiry date at March 2014.
Startlingly, the original label showed the vaccine to be Easy five, the new label called identified as the latter variant Easy five TT.
Rules demand that any such extension of expiry date, raising shelf life from 24 to 36 months has to have prior approval of Drug Controller General of India (DGCI).
While the company had sought and acquired clearance for an earlier batch of Easy five in 2010, it had not cleared the extension for the batch P1062/SBP-A which had labels of March 2014 pasted over the labels of March 2013. It certainly had no approval for extension of Easy five TT.
While the transgression was noticed, raising some dust in Tamil Nadu, authorities and doctors in Pune were clueless about the controversy. Now most of the stockists are unwilling to share information on their handling of the controversial batch. Only two of them accepted that they had about 220 vials between them.
Of these they sold around 30. “I had taken one box with 120 vials. I sold 20 of them and the remaining ones company took back,” said one of the stockists on the condition of anonymity.
Indian Academy of Pediatricians President Pune Chapter Dhananjay Kashikar said, ""This is a criminal offence. I had no idea about this, till I was shown this vial by an associate on Thursday. Fortunately I do not use Panacea Biotech’s vaccine. But there are some others who prefer this company. They too must have had no idea about this.""
When Mirror made queries at FDA, its officials were clearly clueless on the episode. “I have no idea about the issue. We have plenty of files. Maybe some on” else in the office handled the issue,"" joint commissioner (drugs), Pune, division, B R Masal said.
“There was nothing wrong with the batch and we were doing nothing illegal but we withdrew the batch as we cared for the public. The matter is dead now,” defended Karan Desai from corporate communications in Panacea Biotec told Mirror. He could not immediately quantify the size of the consignment that came to Pune.
a-o We were doing nothing illegal but we withdrew the batch as we cared for the public. The matter is dead now
- Karan Desai, Corporate, Communications, Panacea Biotec