Karan Daftary

Rabies Control in India Problems, Review and

Recommendations

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The GenesisIn May 2010, I witnessed an extremely unfortunate incident wherein my friend was bitten by a stray dog. Despite the requisite medical attention, he succumbed to his injuries. This was my first encounter with Rabies –in which mortality is 100%.In October 2010, there was a newspaper article titled “Rabies death despite vaccine” which I came across – the title got my attention as it was contrary to my understanding that a Rabies vaccine shot is all we need for protection against Rabies in case of dog bite. In fact this was the general understanding that even my friends and acquaintances had. On going through the article, it was a revelation for me to know that a vaccine takes almost 7 days time to provide the protection to the human body. This got me going to delve a little bit deeper into this to see what other steps can be taken by people in case of a dog bite. A couple of hours and an internet connection was all I needed to come across the medicine by the name “Rabies Immunoglobulin” which is supposed to provide an immediate protection against Rabies.During this quick search I was also overwhelmed by the enormity of the rabies problem in my country – in fact I was stunned to find that the maximum number of deaths due to rabies happened in India.The question which came to my mind was why India suffered the dubious distinction of largest number of deaths due to rabies and whether this is due to lack of general awareness or availability of Rabies Immunoglobulin. A quick check also revealed that while there are quite a few manufacturers of Rabies Vaccine in India, there were only two manufacturers of Rabies Immunoglobulin.

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Reasons to undertake this Project & PlanReasons to Undertake this project:

To look at reasons why India has so many deaths due to rabies by looking current practice of rabies control in India Since there only 2 manufacturers of Rabies Immunoglobulin, one of them being, Bharat Serums And Vaccines Limited (“BSV”), to interact with BSV and understand whether there could be ways to increase the usage of Rabies Immunolglobulin

PlanMeet with the sales and marketing division of BSV

Visit select doctors in Mumbai Visit the Rabies Immunoglobulin manufacturing site of BSV

Review literature relevant to the project at hand

Introduction on Rabies

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Rabies: A snapshotRabies is a viral infection spread by the bite of an infected animal.

The rabies virus infects the Central nervous system and travels to the brain.

Globally, rabies is the tenth leading cause of death due to infection in humans. Rabies is present on all continents with the exception of Antartica, but more than 95% of human deaths occur in Asia and Africa

Rabies is 100% fatal if not treated immediately

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Incidence in IndiaA brief overview on the disease is provided below:

Indian Population : 1 billion plusEstimated deaths due to rabies : 20,000 annuallyStray dog population : 25 millionEstimated animal bites : 17.4 million.Frequency of bite : 1 bite per 2 seconds.Frequency of Human rabies deaths : 1 per 30 minutes approx.

India contributes to the highest number of human deaths due to rabies in the world

Nearly 50% of total human deaths due to rabies in the world is contributed by India

The post-bite treatment costs the Indian economy over $25 million a year *Children happen to be 40% of the cases most of them below 15 yrs of age.

* India’s ongoing war against rabies. Bull WHO 2009; 87(12): 885-964 National Journal of Community Medicine .

Volume 4, Issue 1, Jan – Mar 2013

Lack of Awareness

Feedback from Discussions with Doctors and salient points:Using only Rabies Vaccines as per Government recommendationsRabies Immunoglobulin has to be funded by patients themselves and hence reluctance to useChildren more susceptible to Rabies– more bites in the face and neck areaReported mortality of 5 to 15% in Category III bites despite active immunisation

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Dr. G. SampathIPM, Hyderabad

Dr. B. J. MahendraMandya Institute of Medical Sciences, Mandya, Karnataka

Dr. AshwathnarayanKIMS, Bangalore

WHO Guidelines on Rabies

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Rabies Treatment regimesDefinition of categories of exposure and use of rabies biologicals

Category III – single or multiple transdermal bites or scratches, licks on broken skin; contamination of mucous membrane with saliva from licks, contacts with bats.

- Use immunoglobulin plus vaccine

Category II – nibbling of uncovered skin, minor scratches or abrasions without bleeding

- Use vaccine alone

Category I – touching or feeding animals, licks on intact skin - No exposure therefore no prophylaxis

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Rabies Immunoglobulin – method of ActionAdministration of Rabies Vaccine stimulates production of neutralizing antibodies by the patient's immune system.

Protective levels of antibodies are seen 7 to 14 days after the initial dose of vaccine.

Moreover when the bites are on the head, neck, face & hands, the incubation period will be shorter

The patients are vulnerable to develop rabies during this window period of 7 to14 days.

Hence, administration of Rabies Immunoglobulin, after thorough cleansing of wounds, is life saving as their timely and proper administration neutralizes the virus in the wound and aborts the risk of developing rabies.

Observations

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ObservationsOn meeting with BSV’s sales & marketing division, the following were the broad findings:

BSV’s current product offering is only Rabies ImmunoglobulinThe cost of treatment of this has to be borne entirely by the patient as this is not part of the Government programs

This increases the economic burden to the patient

Currently, the most common treatment regimen followed in India is the intra-muscular administration of anti-rabies vaccine

As this is in the Government program

Though economical and safe to use, the use of Rabies Immunoglobulin in India has been limited because of:

Challenges in the administration of the product as this had to be administered into the affected area. Non-inclusion in government programs

Economic burden on the lower strata of patients

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ObservationsInclusion of Rabies Immunoglobulin in Government programs as a treatment regimen along with anti-rabies vaccines has its own hurdles:

Inclusion of Rabies Immunoglobulin will increase the treatment cost per patient and will result in more expenditure for the government; andMay not be viable within the current budget allocated by the government

The WHO Expert Committee on Rabies recommended Intradermal route of rabies vaccination (“IDRV”) (1/5th dose as compared to IM) in 1992.

This regimen led to considerable savings in terms of the amount of vaccine needed, thereby reducing the cost of vaccination.This also helped to bridge the gap of short supply of vaccine and increased the availability of the same.

However, the response to implementation of this regimen has been poorInsufficient support from the Government

Findings

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Comparison of Current & New cost of treatment using WHO recommendation of active and passive immunization:

IM ID IM+RIG ID+RIG0

500

1000

1500

2000

2500Vaccine

ARS

Regimen

Cost

of T

reat

men

t (R

s) 1750

350

2350

950

Introduction of the new vaccine method would mean that within the same budget, 5 more patients can be treatedCost savings due to implementation of the above would mean that the Rabies Immunoglobulin can now be included in government funded program within the same budgetIntroduction of the combined treatment regimen would mean within the same budget, approximately 2 patients can be treated

Cost of treatment per patient using WHO recommended approach of active immunization and passive immunization

IM: Intramuscular; ID: Intradermal; RIG: Rabies Immunoglobulin

Requirement of Rabies Ig in India

Total No. of Dog bites ~17.0Mn

Category III bites (10%) ~1.7Mn

No. of vials of Rabies Immunoglobulin per patient

2 vials

Total vials required ~3.4Mn vialsRequirement Availability

0

1

2

3

4

3.4

2.5

Via

ls (

Mn

)

Deficit: ~0.9Mn doses

Conclusion:

Currently, there is deficit of around 30% for the availability of Rabies ImmunoglobulinBy adding about 120-150 horses, BSV can cater to the eventual capacity requirement of Rabies Immunoglobulin for the country

Recommendations

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RecommendationsWork with the government to include Rabies Immunoglobulin in government funded programs as this would go a long way in meeting WHO’s goal of eliminating rabies

To first include the IDRV regimen as a standard therapy for rabies vaccination – this would free lot of financial resources of the Government to allow them to include ARS also

BSV should consider launching a Rabies Vaccine so as to make its product offering more comprehensive

This will make BSV the first company in India to offer the TOTAL SOLUTION for Prevention of Rabies

The education and training of hospital doctors and staff on the New vaccination regimen will increase the treatment of patients who have come with bites

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Food for ThoughtShould BSV consider efficient means of waste management such as conversion to Biogas as an effective means of reducing costs?

400 horses can produce approx. 11.6MWh of electricity

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Acknowledgements

Within BSVDr. Aldon FernandesMr. Adeet GhoshMr. Rahul SrivastavaMr. Gaurav Gurnaney

Outside BSVDr. B. J. MahendraDr. G. SampathDr. Ashish KunduDr. Ranjit Mankeshwar

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Appendix