Polio Vaccine Batches Illegally Traded In Open Market Pass Test At CDL, Kasauli

Mumbai, 20 Feb 2019: The seized polio vaccine vials which were sent to Central Drugs Laboratory (CDL) at Kasauli in Himachal Pradesh for analysis following Maharashtra Food and Drug Administration (FDA) crackdown have successfully passed standard quality test.

The matter is, however, under investigation under Nashik Police and state FDA has filed an FIR against the distributors. Maharashtra FDA had also served show cause notices to retailers in Ahmednagar, Aurangabad and Nashik for trading polio vaccine in open market meant for government hospitals at an exorbitant price of Rs.2,100 per vial.

Administrative action will be taken in violation of Rule 104(A) for alteration of labels under Drugs and Cosmetics (D&C) Rules and Section 18a (vi), 18c and 17b of D&C Act, 1940. Violation under 17b of the said act also amounts to violation for selling spurious drugs. 

The state drug regulator had detected the racket of injectable polio vaccine (IPV) of a reputed brand ShanIPV being traded in the open market three months ago.

Around 200 vials with the MRP label of Rs.2,100 was seized from a distributor in Aurangabad which got the supply from a Nashik based distributor. The seized vials were then sent to CDL at Kasauli in Himachal Pradesh.

Its manufacturer Hyderabad based Shantha Biotechnics Pvt Ltd, in a letter addressed to the state FDA, had clarified that the vaccine is not for sale in the open market and is meant only for government supply. 

Sanofi Pasteur, the vaccines division of Sanofi, launched ShanIPV, an IPV manufactured by its arm Shantha Biotechnics Pvt Ltd in December 2015. ShanIPV is a ‘made in India’ vaccine, manufactured in Hyderabad through technology transfer from Sanofi Pasteur. It is currently approved for use in the Indian market.

ShanIPV has also received prequalification status from the World Health Organization (WHO). The status qualifies ShanIPV vaccine for purchase by the United Nations (UN) agencies.

Over the last two decades, Sanofi Pasteur has been serving the vaccination needs of India by making available the highest quality products. 

India is currently in its fifth year of being polio-free and its seventh, since the last reported polio case. Pharmabiz