Vaccine-maker Sanofi Pasteur has initiated action at multiple levels after vials of Shan IPV, its inactivated polio vaccine meant only for government programmes, was found in the private market.
Confirming the development, the company said, “We have found some vials of Shan IPV in the market with suspected tampered labels. Shan IPV is exclusively sold to Government for use in its National Vaccine Program. Hence, we immediately informed the Drug Authorities and they are investigating the matter.”
Earlier this week, reports citing Maharashtra Food and Drug Administration officials said that about 100 vials had been seized from a distributor in Aurangabad, who had in turn got it from Nashik.
A company spokesperson said that action had been initiated, including filing of FIRs with the police, as well ascontacting doctors and cautioning other distributors. Presently, there have not been similar reports from any other State.
Investigation
“Meantime, we are analysing the suspected sample and the results are awaited. We are unable to ascertain at this stage the involvement of any distributor in the suspected tampered vials,” Sanofi Pasteur's spokesperson said.
Sanofi Pasteur is the vaccines division of Sanofi and only last month it had announced that Shan IPV, developed by affiliate Shantha Biotechnics had received prequalification status by the World Health Organization (WHO).
Results awaited
Whether this is a one-off incident or a “racket” between hospitals and chemists or distributors will be revealed following the investigation. However, the incident comes just after a recent scare in Uttar Pradesh, where the polio type-2 strain had shown up in sewage and stool samples taken during surveillance. This type has long been eradicated globally. Health Ministry-directed investigations said the alleged contamination had come from polio vials sourced from Ghaziabad-based Bio-Med Pvt Ltd, which the company refutes.
The reason why India needs to keep a close watch on any incident involving polio and its vaccines is because India was certified polio-free in March 2014. The last polio case due to wild polio virus (type 1) was detected in the country in January, 2011. But with Pakistan, Afghanistan and Nigeria still to achieve a polio-free status, the immunisation programme needs to be fool-proof with no room for faulty products or diversion of standardised ones.