The Question of Availability of Rabies Biologicals

Most of the available rabies vaccines are indigenously produced in the country. The rabies vaccines are procured by the state governments - the scenario of their availability varies from 24 × 7 availability in Gujarat and Kerala, to occasional supplies in Manipur and Bihar. In fact, there is a 20-80 per cent shortage in anti-rabies vaccines across all States, barring Kerala and Gujarat. However, this is contradicted in an article in 2019, that stated that rabies vaccines had been in short supply in Ahmedabad for nine months.

A 2018 article said that India sees 1.75 million dog bites every year, yet we face up to 80% shortage of anti-rabies vaccines. The government is dragging its feet over controlling dog population, vaccinating them or even making enough shots available for victims.

There was no immunoglobulin for almost a month in Panaji in March 2015. 

Manufacturers remained cold to three tenders floated by Karnataka in 2019 and the State Government had to seek help from neighbouring States. Kerala government responded by providing 10,000 shots of anti-rabies injection and 2,000 vials of immunoglobulin injection.

Recent reports suggest that human rabies vaccine shortage is a common problem also in Punjab (it is a problem even in Delhi Government hospitals, as this report of 2019 shows). 

Rabies biologicals, i.e., vaccines and immunoglobulins are life saving for humans in all rabid animal exposures. These biologicals should be continuously available throughout the year, in the entire country to prevent human rabies.

A 2018 article said that while on the one hand the production is low, states are not procuring enough either due to shortage of funds or maladministration. There is an urgent need for central procurement of rabies vaccines.

In Sep 2019, manufacturers and marketers informed that lack of firm orders by State governments and late payments led to the shortage. The Health Ministry advised State governments to issue quantity based tenders and place long-term firm orders with specific quantity and supply schedule.

A welcome news late in 2019 was that a Gujarat-based plant of Rabies vaccines, shut for a few years, was re-starting production. It had commanded the lion's share of the vaccines market previously. 

Shortages were also caused from Aug 2018 onwards when a major rabies vaccine maker based in China was caught out for fraudulent practices in their manufacture. He had to withdraw vaccines from the market (including those exported to India) and subsequently shut down. 

Looking at reports further back, even in 2008, it was said that the post treatment immunoglobulin was almost impossible to obtain in most of India.

WHO AND CDC Guidelines for Bites

WHO Document

WHO Document

WHO Document

WHO Document

WHO Document

WHO Document

WHO Document

Postexposure prophylaxis consists of a dose of human rabies immune globulin (HRIG) and rabies vaccine given on the day of the rabies exposure, and then a dose of vaccine given again on days 3, 7, and 14. For people who have never been vaccinated against rabies previously, postexposure prophylaxis (PEP) should always include administration of both HRIG and rabies vaccine. The combination of HRIG and vaccine is recommended for both bite and non-bite exposures, regardless of the interval between exposure and initiation of treatment.

People who have been previously vaccinated or are receiving pre-exposure vaccination for rabies should receive only vaccine.

For many types of bite wounds, immediate gentle irrigation with water or a dilute water povidone-iodine solution has been shown to markedly decrease the risk of bacterial infection.

Wound cleansing is especially important in rabies prevention since, in animal studies, thorough wound cleansing alone without other postexposure prophylaxis has been shown to markedly reduce the likelihood of rabies.

You should receive a tetanus shot if you have not been immunized in ten years. 

INDIA'S HEALTH CARE SYSTEM HAS BEEN FAILING US FOR RABIES

Cases of Rabies are invariably fatal once symptoms manifest. More than 20,000 people die of rabies every year in India, three-quarters of them in rural areas. 

Incidence of rabies in India has been constant for the last few years, without any declining trend.

Every animal bite is potentially suspected as rabid exposure as rabies is endemic in India. The exposed individuals should seek early health care and prophylaxis (PEP) should be started immediately at the healthcare facility as it is lifesaving. 

Unfortunately, availability, accessibility, and usage of PEP are limited in India. 

There are many primary healthcare centres in Karnataka where the staff lacks knowledge on how to administer the vaccine, even if it is available, say doctors. 

A study in 2019 showed that in over half of the anti-rabies clinics surveyed in Bengal, Bihar, Gujarat, Himachal Pradesh, Kerala, Madhya Pradesh and Manipur, even facilities for washing wounds and antiseptics -- a critical first step in treating animal bites -- were inadequate. 

Over half the clinics did not have Immunoglobulin which could be critical in preventing rabies if there was blood from the bite wounds, especially on the neck, face or head. 

Two studies carried out in New Delhi and Jodhpur showed many disparities in the knowledge and practices of doctors in regard to rabies. Less than half of them were unaware of the intradermal rabies prophylaxis schedule, and only 45% of them knew about HRIG (immunoglobulin). 81% of them knew of the prophylaxis in unimmunized patients, but only 40% were familiar with the guidelines for previously immunized patients. 

More importantly, public doctors had markedly better knowledge than private doctors in regards to the prophylaxis. This is very concerning, when taken into account that India has the biggest private sector of doctors in the world, accounting for 93% of the hospitals and 85% of doctors.

Post-exposure treatment (HRIG) is simply unaffordable, costing around 30,000 rupees ($447) for an average person. 

Moreover, India notoriously experiences local and national shortages of HRIG, causing the patients who are willing to pay, to wait for it, for weeks or even months, which can eventually lead to death.

A 2018 WHO report said that dog-mediated rabies has been eliminated from western Europe, Canada, the USA, and Japan. 28 of the 35 Latin American countries report no human deaths from dog transmitted rabies.

Great strides have been made in reducing rabies deaths in countries such as Bangladesh, the Philippines, Sri Lanka, Tanzania, Vietnam, and South Africa.

Bangladesh, with almost 10.000 deaths per year and less than six % dog vaccination coverage, has adopted a very successful national strategic plan for the elimination of rabies by 2020. Through the establishment of the District Rabies Prevention Control Centres in almost every district, they provided facilities for mass dog vaccination, dog population management, care of bitten patients, all of whom receive anti-rabies vaccine and immunoglobulin for free. 

Furthermore, local champions were appointed to convince political leaders, policymakers and stakeholders for political commitment and technical leadership and partnership for this assignment. As a result, rabies deaths have reduced by 50% between 2010 and 2013. 

Such an outcome contrasts with the slow progress made in India.

It has been demonstrated in multiple research studies that India’s poor position in rabies elimination is rooted in a lack of knowledge about the disease, uncontrolled canine population, the insufficient vaccination programme, irregular supply of vaccines and inadequate training of healthcare professionals. 

The WHO estimates that investing in rabies elimination globally will eventually free up an estimated US$8.6 billion in economic resources each year. Since over a third of the rabies burden is in India, it should save about US$3 Billion a year by eliminating rabies. 

INTRODUCTION TO THE RABIES AND DOG BITE ISSUE IN INDIA

 Introduction

• Rabies negatively affects the poor living in remote rural areas and slum-dwellers of developing countries.
• Rabies is the deadliest virus-caused disease, where nearly 100 % of the patients die after developing symptoms - but it isnt even notifiable in India. 
• An estimated 17.4 million animal bites occur in India annually.
• Dogs are the source of the vast majority of human rabies deaths, contributing up to 99% of all rabies transmissions to humans.
• By 2010 India had vaccinated just 15% of its dogs. 
• A large number of reported rabies cases and deaths in India occur in children under the age of 15 years.
•  Rabies immunoglobulin is undergoing a critical shortage worldwide. It is also prohibitively expensive for many victims in a country where 60% of the population lives on under US$2 a day: In India it costs about US$7, for each vial. Only three companies produce it, with relatively high manufacturing costs.
• Less than a third of the animal bite cases in India recieve post-exposure rabies prophylaxis.
• A mere 0.33 % of the dog population of India is sterilized every year. An unsterilized female dog can result in 67,000 pups in seven years. 
• In fact, India has not implemented any of the rabies-prevention strategies successfully, be it vaccination, sterilisation of dogs, or providing free medicines to all rabies victims.
• If the level of vaccination in the dog population can be kept at 70 percent over a period of seven years, the variant of the rabies virus that thrives in dog populations will disappear.

The 2020 New Year did not start on a good note for young Praveen and his family at Ballari : The twenty-six-year-old’s eyes are feverish and wild as he hyperventilates on a hospital bed. As his words tumble out in a breathless babble, he explains to a doctor that months earlier, a three-month-old puppy had bitten his leg. Showing the scars, the youth says he was given injections at that time by a local doctor. 

He tries hard to drink water, but screams at the very sight of it. Tormented by thirst, he brings it to his lips again and again, only to convulse and gag at the last moment. Lying alone in a dark room of Isolation Hospital in Bengaluru, Praveen pleads for the lights to be switched off, as they hurt his eyes. It’s a horrible sight for his family, as they watch him suffer. The hospital staff knows there is nothing they can do now. A few hours later, Praveen passes away.

Many countries have gained an efficacious governmental control over rabies, mainly by vaccinating a wide number of human and dog populations, and by implementing other interventions and policies. Only a few countries have managed to completely eradicate the disease. Unfortunately, this is not the case with India. Here the situation has not changed for a decade.

Rabies is a neglected disease, which is insufficiently addressed by the national and international community. Rabies negatively affects the poor living in remote rural areas and slum-dwellers of developing countries. 

Once clinical symptoms appear, rabies is virtually 100% fatal. It spreads to people and animals via saliva, usually through bites, scratches or direct contact with mucosa (e.g. eyes, mouth or open wounds).

Managing a rabies exposure, where the average cost of rabies post-exposure prophylaxis is currently estimated at an average of US$ 108 (along with travel costs and loss of income) can be a catastrophic financial burden on affected families whose average daily income may be as low as US$ 1–2 per person.

Vaccinating dogs, including puppies, is the most cost-effective strategy for preventing rabies in people because it stops the transmission at its source.

India has more than 30 million stray dogs (this figure mentioned in this article also). By 2010 India had vaccinated just 15% of its dogs. The Animal Welfare Board of India was quoted in 2016 as stating that 'Over one lakh stray dogs are sterilized and vaccinated against rabies every year.' - that would be a mere 0.33 % of the dog population of India. 

An article states : 'If a female dog is sterilized, effectively it prevents 67,000 births over seven years.' But since the effort at sterilization is so small, we are adding these dog numbers endlessly to india. 

Once given a vaccination shot, a dog should be safe from catching or spreading Rabies for at least a year. The consensus among rabies experts is that if the level of vaccination in the dog population can be kept at 70 percent over a period of seven years, the variant of the rabies virus that thrives in dog populations will disappear.

In fact, India has not implemented any of the rabies-prevention strategies successfully, be it vaccination, sterilisation of dogs, or providing free medicines to all rabies victims.

An estimated 17.4 million animal bites occur annually (the figure in 2012 was 15 million annual bites a year), and about 5 million post-exposure rabies prophylaxis (PEP) are provided. 

Over the years, India’s stray dog population has grown.

For example, stray dog population has gone up by 65% within seven years in Chandigarh. This was revealed in the 2019 animal census conducted by the UT animal husbandry and fisheries department. 

Between January and March 2015, Chandigarh registered 1,200 cases of dog bite. 

On an average, nearly 6,000 cases of dog bites are being reported in Ahmedabad every month. This means roughly 200 people are bitten by dogs every day in the city.

A study showed that dog sterilizations in Ahmedabad reduced bites by only 8.5 %. 

Statistics from Pune Municipal Corporation reveal that, “at least 28 citizens were bitten every day by stray dogs making for an average of 10,000 dog bite cases in 2017. 

Nearly 50 per cent of those bitten by a dog in India do not receive rabies vaccine.