|
Polio vaccine batches illegally traded in open market pass standard quality test at CDL, Kasauli
|
|
Shardul Nautiyal, Mumbai
February 21 , 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.
|
|
|
|
|
|
|
|
TOPICS
|
That foods might provide therapeutic benefits is clearly not a new concept. ...
|
|
|
|
|