CD
मुंह पका खुर पका रोग के वैक्सीन की गुणवत्ता में घोटाला और ड्रग कंट्रोलर जनरल ऑफ इंडिया (DCGI) की चुप्पी: ठगा जाता किसान और भारत देश
#Corruption in #NADCP #India
Foot-and-mouth
disease (FMD) is a highly contagious disease of cloven-hoofed animals. The
disease was initially described in the 16th century and was the first animal
pathogen identified as a virus. FMD is a vaccine-preventable disease
and several countries are free of FMD. As per WTO guidelines, countries free
from FMD do not import animals and their products from countries having the
disease. Due to the restrictions on exports of animal products from India to
all the FMD free Nations Indian livestock owners lost about Rs. 20000 Crores
every year. Besides, the government of India spends Rs. more than 2500 Crores every
year for the control of the disease in India
(https://pib.gov.in/PressReleaseIframePage.aspx?PRID=1598062#:~:text=13%2C343.00%20crore%20for%20five%20years,the%20economic%20output%20of%20farmers.)
under Mission Doubling farmer’s income by Govt. of
India.
The control of any disease through vaccination is dependent on several factors such as timely vaccination coverage, vaccine potency to induce herd immunity, and
vaccine quality. The vaccine quality is of prime importance because if the
quality is compromised all other efforts are wasted. To ensure vaccine quality
Indian Pharmacopeia (IP) rules are implemented by the Drug Controller
General of India and DCGI staff. However, to keep FMD live forever DCGI and its
associates have flaunted the guidelines of the IP and OIE-World
Organisation for Animal Health
(https://www.oie.int/eng/A_FMD2012/docs/2.01.05_FMD.pdf).
To control FMD multivalent inactivated
whole-virus (strain O, A, and Asia one of FMD virus) a preparation is
formulated with adjuvant prior to use in the field. The introduction of this
killed FMD vaccine has been extremely successful in controlling and eradicating the
disease in many parts of the world where the disease was enzootic. As per OIE
guidelines, the finished vaccine must be shown to be free from a residual
live virus. This is most effectively done using in-vitro tests
on concentrated inactivated virus preparations prior to the formulation of the
vaccine and freedom from the live virus is subsequently confirmed during in-vivo and/or in-vitro tests
on the finished product. The presence of the live virus is detected through NSP
(non-structural proteins, only expressed in the host when a vaccine contains
the live virus) antibody test done through in-vivo tests.
However, the
Minutes and proceedings of the second National Steering Committee (NSC) meeting for the National Animal Disease Control Programme for FMD and Brucellosis held on 20th
November 2019 clarify (on pages 9-11) that if an FMD vaccine fails in the NSP test
(the test is done for the purity of the vaccine and assures that all viruses are
killed in the vaccine, as this test is positive only when antibodies for
nonstructural proteins are detected after vaccination;), only 40% of the
Balance payment amount (25%), i.e. 10% of the total payment will be given to
the manufacturer. The remaining 15% will be the penalty imposed on the manufacturer.
The NSPs are expressed in an animal only when there is an FMD virus
infection; which means the vaccine is capable of causing infection of FMD. The
expression of NSP indicates that the vaccine is of sub-standard quality and capable
of spreading the disease and causing disease outbreaks. In the past
several post-vaccination outbreaks have been reported from different parts of
India including in the Premier Indian Veterinary Research Institute, Izatnagar.
Releasing 85% of the payment (vaccine cost) to the producers of such vaccines
is treachery to the Nation, instead, such pharmaceuticals producing the
vaccines capable of spreading the disease must be harshly punished and
blacklisted forever. Instead, the members of the National Steering Committee meeting
for the National Animal Disease Control Programme decided to reward pharmaceuticals for producing the vaccines capable of spreading the disease by
advising the Government for the release of payment.
Such firms would
have been blacklisted and penalties to the tune of many times the total
amount of vaccine should have been imposed. Further, who will compensate the
livestock owners and who will inform them of their animals being administered
poor quality vaccines. Further the vaccine is also administered to cattle
and it is not known how many cattle have faced adverse health effects or
have died and if died. Using a vaccine not protecting the cows but has the
potential to cause the disease is an intentional cow slaughter and a heavy
punishment is prescribed for cattle slaughter.
As per the NSC meeting
minutes, the vaccines inducing SN50 antibody titers (1:64 for Serotype O and
1:48 for Serotype A and Asia-1) in 75% (12 out of 16) animals of each of the
potency testing groups will satisfy the criteria for acceptance of the vaccine
quality. There is no available literature reference in the Indian
Pharmacopoeia and OIE manual for using the proclaimed antibody titer-based
criteria and seems to be an arbitrary assumption by the biased (towards Vaccine
producers).
As per OIE, the
finished vaccine must be shown to be free of residual live virus. This is
usually done by combining in-vitro tests on the
inactivated virus preparation and in vivo tests with the finished vaccine.
Challenge tests are also conducted in vaccinated cattle to establish a PD50
value, although a serum neutralization test is considered satisfactory where
the vaccine producer has established a statistically significant correlation
between protection and specific serum neutralizing antibody ( https://www.oie.int/doc/ged/D7722.PDF). However, the biased NSC has not
mentioned it as a required test. Why? No one knows.
As per OIE, (https://www.oie.int/eng/A_FMD2012/docs/2.01.05_FMD.pdf) the shelf life of conventional FMD
vaccines is usually 1–2 years at 4°C (maximum range 2–8°C), but they are
temperature labile and should never be frozen or stored above a target
temperature of 4°C. The stability of all vaccines, but particularly oil
emulsion vaccines, should be demonstrated as part of the shelf-life determination
studies for authorization. However, the biased NSC again maintained silence
over this aspect and did not mention it as a required test. Why? No one
knows.
The FMD vaccine
used in India is an oil emulsion vaccine for which stability of the emulsion is
recommended for all emulsions by the IP. It is mentioned in all old volumes of
IP (IP 2014, on page 955 of volume 2) mentions that “Injections that are
emulsions should not show any evidence of separation-------”. However, the NSC
flaunted this requirement of IP in their guidelines for monitoring the FMD vaccine
used in NADCP.
The NSC
recommended that “ten vials of every batch of FMD vaccine produced by the
manufacturers will be collected on a random basis out of the whole lot of each
batch by the officials authorized by DAHD/NAFED. Vaccine manufacturers will facilitate
such collection of vaccine samples and the maintenance of the cold chains for
transportation. Samples of all the batches collected by the officer will be
submitted to the designated institute”. However, the IP (2014, 2018) (page 59 of
chapter 2.2.11.STERILITY of IP 2014) (https://www.pharmaguideline.com/2011/11/sop-for-procedure-for-sterility-testing.html) and European Pharmacopoeia 2008,
recommended that for sterility testing of FMD vaccine, 20 vials should be used.
Why did the biased NSC reduce the number of vials of each batch to be tested to 10
only the members can understand?
The reality is
still more bizarre, instead of 20 vials, the NSC recommended 10 vials and the testing agency received only 7 vials of each batch i.e., the implementation of
biased guidelines of the NSC was further diluted.
The NSP guidelines
were flaunted by not taking any action against defaulter vaccine producers. The
Guideline mentions that “ If three consecutive batches of vaccines of a
particular manufacturer fail QC tests, then purchaser/ Nafed shall not take
supply from the vaccine manufacturer concerned and this information shall be
shared with the Department (DADH) so that DCGI is informed for taking necessary
further action.” Though the department informed DCGI to take action against
defaulter firms (as 9 batches of three firms failed consecutively) but DCGI has
not initiated any action indicating a coalition of DCGI and producers of
substandard FMD vaccines to bluff the country for the program costing Rs. 13343
Crores.
The NSP guidelines
(page 7) mention that “The sample vials will be coded and anyone out of every
5 batches will be randomly selected and will be sent to three laboratories
designated by DAHD for testing of the FMD vaccine. 16 cattle for potency, 2 cattle
for safety and 2 cattle as control of 6 to 8 months of age will be used for
quality control testing by these laboratories.” In the year 2020, a total of 169
batches of FMD vaccine for use in NADCP were used and sampled and as per rule
32 batches must have been tested but no more than 25 batches have been tested
and who knows that they were either randomly chosen or targeted ones. Of the
ten FMD vaccine batches sent for testing to one of the institutes 9 failed while
one passed was also in a real sense must have failed as NSP antibodies
were detected in inoculated animals but passed. This means that the majority of the
vaccines of FMD used were of substandard quality.
Besides DADF other people have written to DCGI long ago. Still, it has not taken any cognizance of the
ongoing corruption in FMD vaccine quality control probably due to its own
involvement. As a result of the use of substandard FMD vaccine FMD outbreaks
are occurring in many places and farmers (livestock owners) are suffering due
to rampant corruption in the system. The whole episode mentioned above
indicated that a corruption syndicate is working at a very high level in the
country and an urgent intervention is needed in the management of NADCP and
its funds.
An outbreak of a mysterious disease in Meerut killed 40 cattle. The mysterious disease: Identified as FMD by Professors of Meerut Veterinary College.
