As per the records, the world’s one-third of the rabies deaths are from India. According to the Health Ministry, India is the hotbed for human rabies. India is currently facing a shortage of ant-rabies vaccines in certain part of the country. The National Pharmaceutical Pricing Authority has asked the manufacturers and marketers to rush stocks to the areas that are suffering from a severe shortage of anti-rabies vaccines. In India, approximately 20,000 deaths are caused due to vaccine-preventable fatality each year. Therefore, rapid response to this issue is a need of the hour.
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- Rabies is a viral disease with a very high mortality rate. It is especially difficult to treat after the onset of symptoms and very often results in death.
- It is caused by Lyssaviruses which are RNA based and uses vertebrate life forms as its host.
- It is transmitted through bites, scratches or saliva from infected dogs, bats, cats, cattle, mongoose, etc.
- The symptoms of infection start appearing as early as a week from contracting the virus or as late as a year later. Most frequently, the symptoms appear a month or three after the infection. Symptoms include fever, violent movements, hydrophobia/ fear of water, excitement, unconsciousness, etc.
- The prognosis/ most probable course of the disease is nearly always death.
How prevalent is rabies in India?
- India has the highest number of deaths due to rabies. The deaths constitute around 36% of all rabies deaths around the world.
- In most of the cases, the infection was from dog bites. This is about 96% of the cases. India has a stray dog population of 30 million. Annually, over 1.75 million dog bites are reported in the country.
- Rabies is listed as a ‘Neglected Tropical Disease’. It is more prevalent in rural areas. Children are affected more often than adults.
- National Health Profile 2018 lists rabies as a deadly killer with every infected individual dying that year. The National Health Profile is published by the Central Bureau of Health Intelligence.
- The government data reports a 60% year-on-year drop in the number of rabies deaths in the country since 2011 (except 2017).
- However, the data may be an underestimation as rabies is not a notifiable disease in India.
How is rabies controlled in India?
- Rabies is treated by the use of vaccines (anti-rabies vaccines/ ARV). This is to be administered after being bitten by an infected animal. Some pet-owners and cattle owners tend to take the shots as a precautionary measure.
- 5 shots of the vaccine are required for effective protection. This administration is time-sensitive. Each dose is priced at around 350 INR/ shot.
- The National Centre for Disease Control (NCDC) and WHO Collaborating Centre for Rabies Epidemiology formulated guidelines for standardised rabies prophylactic treatment in 2002. Prophylactic treatment is a preventive form of treatment. The guidelines have been reviewed several times.
- National Rabies Control Program was constituted with human and animal health components under the 12th five-year plan.
- The human component of the NRCP is managed by the NCDC. It is composed of:
- Laboratory strengthening
- Health professionals’ training
- Strengthening surveillance of rabies in humans
- Use of intradermal injection of cell culture vaccines
- Information, education, and communication (awareness aspect)
- The animal component is under the purview of Animal Welfare Board of India. It involves:
- Mass vaccination of dogs
- Population control of stray dogs
- Population survey of stray dogs.
- The guidelines involve a 3-pronged approach for treating rabies. This post-exposure prophylactic treatment involves:
- Wound management
- Passive immunisation: provides immunity in the form of ready-made antibodies that specifically bind and neutralize rabies virus. This is through the administration of RIG/ Rabies Immunoglobulin.
- Active immunisation: this is through the administration of cell culture vaccine (CCV) or purified duck embryo vaccine (PDEV). This aspect stimulates the patient body to produce its own defence against future infections.
What is the status of ARV in India?
- ARV is included in the National List of Essential Medicine. Such listed medicines are subject to price control measures by the state as they are regarded as essential for maintaining basic health security in the public.
- ARV cannot be mass-produced overnight as it involves complex procedures.
- The pricing of such medicines is controlled by the NPPA/ National Pharmaceutical Pricing Authority.
- NPPA’s function includes assessment of drugs’ supply and storage in the states, taking corrective measures to address the shortage, control pricing of essential medicines, etc.
- India has an annual requirement of about 40 million doses of ARV.
Why is there a shortage in ARV?
- The shortage is not due to dearth of ARV production in India. The pharmaceutical companies produce a surplus every year. Against a demand of 48 million doses per year, the country produces 50 million doses.
- A large portion of the ARV produced is exported to other countries. Some of the importers of Indian ARV are Bangladesh, some African countries, Turkey and Myanmar.
- When state health bodies float tenders for ARV supply to the manufacturers, poor participation is seen.
- Manufacturers of ARV state late payments by the state health bodies as a reason for not participating in such tenders.
- Another reason stated by the manufacturers is the lack of firm orders, such as the time frame, quantity/ doses required, etc. from the states.
- This becomes an issue, especially as the vaccine involves cell culturing and other complex processes. Unlike common drugs like paracetamol, these vaccines cannot be mass-produced overnight.
- State governments tend to procure insufficient doses of ARV due to fund shortage or poor administration.
- The rural areas, which has more rabies cases, also face the most ARV shortage because of the centralisation of the health infrastructure near urban settlements. The shortage ranges from 20% to 80% in some cases. Eg: Mizoram.
- As the ARV is listed under the NLEM, its mass production does not yield as many profits as that of non-NLEM drugs. This reduces the incentive for new players to enter the business.
- The current shortage was specifically driven by the sale of Chiron Behring Vaccines. This is a manufacturing unit of GlaxoSmithKline (GSK). This unit in isolation had been supplying about 25% of the annual demand in India.
- Upon its sale, the sourcing of 10 million doses that were supplied by it every year has become uncertain.
- Another major supplier, Bio-Med, is facing charges against one of its other products (Oral Polio vaccine). This led to the manufacturer limiting ARV supplies.
- Currently, NPPA has been holding stakeholders’ meetings to assess the problems leading to the shortage.
- The state governments have been directed to float tenders with clearly defined requirements of quantity and supply schedule. The NPPA also advised the state governments to place long term firm orders.
- Government has been in talks to ask states to include ARV in their respective essential medicines’ list.
- The government has been speculating the imposition of export restrictions on ARV manufacturers, under the Drugs and Cosmetics Act. India Immunologicals, which has the largest capacity for ARV production in India, exports 50% of its stock while the rest is supplied to the state hospitals.
- Very high demand has a tendency to breed poor quality supply and lower compliance with standards. This is to be taken into account while addressing the shortage. Earlier, the government had banned the import of ARV from China when the regulators found it to be non-compliant with the standards.
- Very high demand also leads to the creation of a black market where the vaccines would be exorbitantly priced. A well-oiled drug quality regulator is essential to curb it. The public must be encouraged to get vaccinated only from recognized healthcare centres.
- State governments’ issuing well-defined orders would solve the uncertainties among the manufacturers.
- The state government could diversify the ARV sourcing to keep the anti-rabies program immune from fluctuations in market activity.
- Culling of stray dogs is prohibited in India. Instead, sterilisation is recommended for controlling the canine population. The reasons for the improper implementation needs to be looked into and addressed. Eg: inter-ministerial coordination and funding.
- WHO recommends that 80% of the dogs be vaccinated against rabies to break the transmission cycle. However, the AWBI has succeeded in vaccinating a poorly 2.4% of the population in a decade. This needs to be addressed immediately.
- This is not only for the sake of human welfare but also for other animals’ welfare. A study around Gir forest showed that a large percentage of stray dogs had evidence of rabies infection at some point. This shows the danger faced by protected species like the Asiatic lions which are also vulnerable to the disease.
- Public awareness programs are key to solving the rabies problem in India. As the disease is more prevalent in the rural populace, efforts could be more focused on the villages and in schools.
- Season specific planning and measures are vital given the uptick of the disease’s incidence in summers.
- Research and development in ARV need to be encouraged to develop a more potent and cheaper counterpart.