TechNet-21 - Forum

This forum provides a place for members to ask questions, share experiences, coordinate activities, and discuss recent developments in immunization.
  1. Omesh K. Bharti
  2. Service delivery
  3. Monday, 07 December 2009
Rabies has been one of the most dreaded diseases, often leading to painful death in human beings. Globally, around 55,000 people die of Rabies and, of them, 20,000 die in India alone. The animal bite incidence rate is 17.4/1000 that is 17.4 million bites every year in India. The frequency of animal bite is 1 every 2 seconds and that of death is 1 case every 30 minutes. The annual medicinal cost (vaccines + other drugs) for treatment of animal bite in India is Rs. 2 billion and annual man days lost due to animal bite is 38 million. The discovery of nerve tissue vaccine (NTV) was a great savior for the animal bite victims and served the purpose for many years. Later, in 2004, the use of this vaccine, that was administered free of cost, was stopped by the supreme court in the country, citing some rare reactions but without bothering about the fate of the millions of poor people who were going to die for want of an affordable vaccine in the absence of a NTV. In my brief clinical career I myself saw such cases that, because of the cost, could not afford the vaccine and died due to Rabies; a recent case occurred just two months back in the Hamirpur district of Himachal Pradesh. With the supreme court banning the NTV, it was celebration time for many private antirabies vaccine manufacturers as there was acute shortage of the vaccine all over. The champions who helped these companies put up a strong case for stoppage of NTV did not bother either to look for an alternate that is affordable or ask these companies to allow intradermal use of the vaccine like they were doing in foreign countries. The cost of one complete course of antirabies vaccine (ARV), is around Rs.2220/- when given through an intramuscular route but the costs come down to Rs. 370/- when the antirabies vaccine is given intradermally. WHO recommended the use of cost effective intradermal regimen (IDRV) in 1992 and the same was introduced in Thiland, Phillippines and Srilanka subsequently by 1996. In India, many NGOs demanded that the IDRV be started in India as well but a powerful vaccine lobby along with the corrupt officials did not allow this to happen. When the pressure to start IDRV mounted, the lobby invented a noble way to prevent the introduction of a well-tested intradermal route saying that first the trials for efficacy and effectiveness of intradermal vaccine be undertaken in India before giving any approval. 10 years after the cheap intradermal route of antirabies vaccine was approved by WHO, the Indian government ordered the trials to be conducted by ICMR in the year 2003-2006. Now the efficacy was proved beyond doubt but the drug controller dragged his feet to block the implementation by putting an arbitrary ceiling of 50 patients. If someone wants to give intradermal antirabies vaccination in India and it was essential that the vaccine manufacturer mentions on the vaccine label that the vaccine is fit for intradrmal use and the label should mention 'for IM/ID use', which they were unwilling to do. No timeframe was set to ask manufactutrers to write on the label nor were the government vaccine manufacturers asked to expedite the amendment to the label of the vaccine to facilitate easy accessibility for the poor patients. Again the winners were the vaccine manufacturers and the lobby they were feeding to block the access to a cheaper vaccine. After many protests, the DCGI lowered the limit from 50 to 10 patients if someone wants to give IDRV, making it again difficult to gather these many patients to start IDRV. It was for the first time that DCGI was deciding the number of patients for use of a vaccine rather than the route and potency of a vaccine. The same DCGI office has allowed the marketing of highly costly like Hib, Pneumococcal and Monovalent polio vaccines based on the trials conducted outside the country and is still allowing such drugs and vaccines that have not been tested or undergone field trials on Indian populations. While the DCGI office was dragging its feet to give permission to use the intradermal antirabies vaccine, Dr. M.N.Siddiqui, a courageous man, along with the government of U.P. started the first antirbies intradermal clinic on 19 May 2006 in U.P., and then there was no looking back. Now already nine states have started IDRV and many are going to start it soon. The nine states to start IDRV are U.P., Orrissa, A.P., Karnataka, W.B., H.P., Kerala, T.N. and Uttrakhand alongwith a clinic each in J.J.Hospital Mumbay and at Ganiyari village clinic in Bilaspur district of Chattisgarh. The mechanism of action of intradermal vaccine is that it is directly presented to the immune system (axillary lymph nodes) and does not undergo dilution in the blood as is the case in intramuscular delivery; therefore a small amount of vaccine given intradermally is enough to produce the desired immunological response. Because the volume of the vaccine used for intradermal delivery is one-fifth of that of intramuscular delivery, the cost of IDRV also comes down to one-fifth of the cost for intramuscular vaccine. With more and more states opting for the intradermal route, pressure has been put on more and more companies to come forward to write 'IM/ID' on the label and two of the vaccine companies have made vials for ID use and more are assuring to do so soon. Unnecessary expenditure on the part of the poor patients and the government has been reduced since the IDRV started in India and more than a million doses have been given inradermally without a failure. Still a lot needs to be done, as the government and companies are still not serious to promote IDRV, e.g. the Delhi government can save more then 45 crores annually by shifting to IDRV from the IM route and money saved can be used to provide free rabies immunoglobulins to save lives; but there is laxity on this front and nobody is ready to take the responsibility. Similar is the case with other state governments that have not yet started IDRV. In Himachal, in a short period of eight months, we have vaccinated 2020 animal bite victims (8080 doses) and have saved more than 3 million rupees and hope to save millions when intradermal vaccination for rabies post-exposure prophylaxis becomes a routine in future. Also we are helping our neighboring states to start IDRV as early as possible to make the benefit of a life-saving vaccine reach the masses that is now available at an affordable cost; already they have been made to wait for more than 16 years and need not wait any more due to the apathy of decision makers! Thanks Dr. Omesh Kumar BhartiM.B.B.S.,D.H.M.,M.A.E.(Epidemiology)Directorate of Health Safety and Regulation, Himachal Pradesh+91-9418120302[email=bhartiomesh@yahoo.com]bhartiomesh@yahoo.com[/email]; [email]bhartiomesh@gmail.com[/email] The INTERNET now has a personality. YOURS! See your Yahoo! Homepage.


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