Vaccines and Vaccine Quality, is a very sensitive topic, especially in India where quality matters little over quantity. There are numerous problems with no or little will to solve the vaccine quality riddle. Patriotism and truth have become obsolete traits in front of greed for power.

1. Vaccines in India: Problems and
Solutions
Bhoj R Singh
Principal Scientist & Head of Epidemiology
ICAR-IVRI, Izatnagar, India
The Lecture Delivered to Students and Faculty of Veterinary College, GADVASU, Ludhiana on
invitation of the Vice-Chancellor on 24-03-2022
https://azad-azadindia.blogspot.com/
Vaccines and Vaccine Quality, is a very sensitive topic, especially in India
where quality matters little over quantity. There are numerous problems with
no or little will to solve the vaccine quality riddle. Patriotism and truth have
become obsolete traits in front of greed for power.

2. Truth the essence of ensuring quality
• What is it? Accuracy, authenticity, certainty, fact,
legitimacy, principle etc.
• Types: Gospel truth (revealed by Gods or messengers of
God), Naked truth, Unpolished/ polished truth,
unvarnished/ varnished truth, plain truth, whole story,
honest truth etc.
• Truth Spoken while sitting on higher chair.
• Is it Universal or changes?
• Satyam Shivam Sunderam! Is it true?
• Palatability: some have sweet tooth other like bitter &
pungent too.
• Is it opposite to falsehood or have its own individuality?
• लोगों का दिल अगर जीतना तुमको है तो बस मीठा
मीठा बोलो
• Does truth always win?
• Truth hurts or heal!

3. Some Facts of Indian Vaccine Market
1. The only Country where the Government purchase
Vaccines (FMD vaccine) costing billions of rupees every year
without getting tested for quality before purchase.
2. The only Country which uses vaccines in millions of
recipients without any quality assurance (FMD vaccine,
Brucellosis vaccine) before use.
3. The only Country which releases vaccines without any valid
2nd and 3rd phase trial (Brucellosis vaccine).
4. In case of casualty in vaccinated livestock, Government of
India show generosity to pharmaceuticals leveling no
liability on substandard vaccine producers.
5. The Government of India pays 85% of the vaccine cost
even if the Vaccine is capable of spreading the disease
through having a live FMD virus.

4. Quality vaccines in India?
•28 vaccine producers (23 produces human vaccines
only) or producers & suppliers (37) of vaccines in
India for 27 diseases of Humans
•Healthy Competition is shrinking due to closure of
public Sector Vaccine producers.
•Many of the Vaccines are made from imported
strains not from Indians strains causing disease in
India.
•No precise information is available on disease causing
strains circulating in different regions and at national
level.
•No producer for customized vaccines.

5. Share of Public Sector in Installed Capacity and Production of Vaccines in India, 2019

6. List of Vaccines for animals (MHFW)
• Essential Vaccines
– Foot and Mouth Disease (Trivalent) Oil adjuvant vaccine
– Brucella abortus (S19 strain) Vaccine, Live Freeze Dried.
• Other Vaccines
– Anthrax
– HS
– BQ
– Enterotoxemia
– R-9 and other Salmonella vaccines
– PPR Vaccine
– Pox vaccines (Camel pox, Sheep Pox, Goat Pox, Buffalo pox)
– Orf Vaccine
– LSD Vaccine
– Poultry vaccines (many)
– Horse vaccines (many)
– Dog vaccines (many)
Important Endemic Diseases in India: Foot and Mouth Disease (FMD), Bluetongue (BT), peste des
petits ruminants (PPR), Sheep pox , Goat pox, Camel pox, Infectious Bovine Rhinotracheitis (IBR),
Malignant Catarrhal Fever (MCF) and bacterial disease like Haemorrhagic Septicaemia (HS), Black
Quarter (BQ), Anthrax, and Brucellosis are endemic.
Important Zoonotic diseases: Brucellosis, Tuberculosis, Glanders, Corona, Influenza, Hendra and
Nipah.
Source:
https://main.mohfw.gov.in/sites/default/files/Report%20of%20the%20committee%20constituted
%20for%20preparation%20of.pdf

7. Testing of Vaccine Quality in India
•There are more than 35 vaccine producers & suppliers of
veterinary vaccines in India producing and distributing more
than a thousand vaccine batches. You may imagine the
number of batches by the fact that every year IIL produces
~180 batches of trivalent FMD vaccine only.
•On an average 40 vaccine batches are tested annually for
Quality and most of the testing is done for the batches
submitted by the vaccine producers.
•On an average DCGI drug inspectors collect 6 samples every
year for quality regulation of veterinary vaccines (2015-16, 5;
2016-17, 7; 2017-18, 12; 2018-19, 4; 2019-20, 6).

8. Veterinary Vaccine Quality Testing
Facilities in India
• At present only three testing facilities
(all under umbrella of ICAR, DAHD)
– ICAR-IVRI (all vaccines and biological products)
– CCS-NIAH (FMD, PPR, RD, BQ, Fowl pox, Sheep pox only)
– ICAR-International Centre for Foot & Mouth Disease
(FMD only)
What an umbrella holder can do?
1. Can test vaccine just by reading Production Protocol.
2. Can produce, pass and distribute Mallein (a diagnostic antigen) from
Micrococcus strains instead of Burkholderia mallei.
3. Can pass all poultry vaccines without using a single SPF egg or chick.

9. Conflict of Interests
• Most of the Vaccine technologies for
veterinary vaccines in India are generated at
ICAR institutes & two of the testing facilities
are under ICAR only.
• IIL, the largest producer of veterinary vaccines
in India, is part of NDDB (an organ of DAHD)
and CCS-NIAH, a vaccine testing facility, is also
an organ of DAHD.

10. Solution
• Revamping of vaccine and vaccination policy
(https://www.researchgate.net/publication/332263494
_Proposal_for_Vaccine_and_Vaccination_Policy_for_C
ontrol_of_Animal_Diseases_in_India).
• Truthful implementation of the policy and monitoring.
• Fixation of liability of producers, distributors, quality
regulators, vaccinators & monitoring agencies in case
of vaccination failure and disease outbreaks.
• Ensuring “no inter-dependence of vaccine production,
vaccine quality control, implementing (purchasing,
distributing, vaccinating) and monitoring agencies”
which at present are just on the same face of the coin.

11. Some references
• https://www.researchgate.net/publication/332103614_Indian_Disease_Dissemina
ting_Research_Institute_IDDRI
• https://azad-azadindia.blogspot.com/2018/06/veterinary-drugs-and-their-quality-
in.html
• https://azad-azadindia.blogspot.com/2021/05/the-truth-of-adenovirus-virus-
vectored.html
• https://azad-azadindia.blogspot.com/2019/05/foot-and-mouth-disease-control-
program.html
• https://azad-azadindia.blogspot.com/2019/06/livestock-farmers-of-india-are-
losing.html
• https://azad-azadindia.blogspot.com/2021/07/india-worlds-most-corporate-
pharma.html
• https://azad-azadindia.blogspot.com/2019/08/my-letter-to-director-indian-
veterinary.html
• https://azad-azadindia.blogspot.com/2021/02/corruption-in-fmd-vaccine-
quality.html
• https://azad-azadindia.blogspot.com/2021/01/india-worlds-most-corporate-
pharma.html

12. Thanks to the Vice Chancellor
GADVSU, Ludhiana for providing
me the opportunity to
communicate with students and
faculty of Veterinary College,
GADVASU.