Rabies is a disease affecting mostly the socially and economically weak and illiterate persons. It has never been given its due importance. Rabies is 100% fatal yet 100% preventable (if dealt with according to w.H.O. guidelines).
Rabies is present in an endemic form in India. In the state of Uttar Pradesh itself, not less than 3 million cases of animal bites occur annually leading to more than 4000 deaths due to rabies. From May 2006 to April 2007, deaths due to rabies reduced significantly by more than 50% in Lucknow district. This was due to the administration of vaccines, intradermally, to the animal bite patients who approached the Anti-Rabies Clinic at Balrampur Hospital, Lucknow. This decrease was not due to the superiority of intradermal(lD) administration over intramuscular(lM) administration but because, now the same number of vaccine vials could be used to administer anti-rabies vaccination for post exposure prophylaxis(PEP) to a larger number of patients. Although the Uttar Pradesh Government allocated an annual budget of 30 crores rupees for rabies vaccination during the last financial year, yet there was a shortage of vaccines. Intradermal administration helped in overcoming this shortage.
The Semple vaccine (a Nerve Tissue Vaccine derived from sheep brain) was manufactured at the State Health and Immunological Institute situated at Patwadonger in Nainital (now in the state of Uttarakhand). Although this vaccine was supplied to all the ARCs at all Government hospitals, in U.P, free of cost until the year 2000, there was always a shortage. Even at Balrampur Hospital, Lucknow, (one of the biggest and most reputed hospitals in U.P), where vaccines were supplied on a priority basis, sometimes there were reported shortage of vaccines for a few days, despite the Government's best efforts.
With the partition of U.P into two states (U.P and Uttarakhand) on 8 November, 2000, the State Health and Immunological Institute, Patwadonger, Nainital, became an asset of Uttarakhand. This forced the U.P Government to now buy the Semple vaccine. The modern Tissue Culture Vaccine (T.C.V.) was thus, brought in but was used only by the well-to-do and VIPs. With the introduction of T.C.vs, the usage of Semple vaccine was considerably decreased. Moreover since the Semple vaccine had to be bought now, there was always a shortage. So the Government decided to buy both, the Semple vaccine and the TCVs. Thus, by March 2004, both these vaccines became available at all government hospitals. Also, the private sector got hold on ARVs, by using the TCVs readily available in the market. The Semple vaccine was never available to them. All TCVs were administered using Essen schedule. In U'\d' the last Semple vaccine was administered on 23 March, 2004.
By June 2005, a trial for intradermal administration of Verorab vaccine was started by Dr. Mohd. Nasir Siddiqui (as principal investigator) at Balrampur Hospital, Lucknow, with due permission of the Drug Controller General, of India and the Director General of Health Services of U.P as well as of India. A similar trial was started simultaneously at Kolkata by Dr. Amlan Goswami and at Hyderabad by Dr. Gadey Sampath. The trial titled "Immunogenity and safety of Purified Verocell Rabies Vaccine (PVRV, Verorab 1M) administered for rabies post-exposure treatment. Comparison of Essen-1M, Zagreb-1M, and Thai Red Cross (TRC)-ID regimens in the Indian population" was successfully completed by March, 2006.
Based on the recommendation of the expert group as well as W.H.O., it was decided to allow intradermal route of administration for TCV in post-exposure treatment of patients in a phased manner. The schedules and vaccines endorsed by WHO (WHO TRS 931, year 2005) for intradermal route and the schedule recommended by ICMR Study were permitted. This was in accordance to the letter no. X-ll026/23/05-D from D.C.G.!. dated 28 February, 2006.
Due to the shortage and unavailability of vaccines, the poor and illiterate were the major lot to suffer. Keeping this in mind, the Director General of Health Services directed through letter no. DG/C-P/929 dated 5th May, 2006 to start IDRV in U.P. The decision was also supported by the Director at Balrampur Hospital via letter no. BH/2006/1428 dated 18 May, 2006. Thus, the first Intra Dermal Rabies Vaccination(lDRV) in a regular Anti-Rabies Clinic, in a Govt. Hospital(or any hospital) in India, was administered to regular patients(and not to selected trial subjects) at Balrampur hospital on 19 May, 2006 by Dr. M. N. Siddiqui in presence of D.G., Health Services u.P.. The updated TRC regime (2-22-0-2) 1 was followed in which O.lml vaccine (Verorab by Sanofi Pasteur or Rabipur by Chiron Behring Vaccine Put. Ltd.), having potency of 2.5 IU/ 1M dose, was administered, at both deltoid regions on 0th ,3rd ,7th and 28th day (i.e. no vaccination on the 14th day). A short and detachable needle of 29/30 gauge was used (and is still being used) with an insulin syringe. The usage of a detachable needle results in 25 % wastage of vaccine per vial. If a fixed needle syringe is used then this limitation can be overcome. Yet due to certain technical limitations, the detachable needle syringe is used. Later on, the ARCs at over 60 district hospitals also adopted the IDRV method.
Another fact which needs to be brought to notice is that almost 150-250 cases of animal bites are dealt with at Balrampur Hospital per day, facilitating the immediate use of open vials. Moreover, the use of 1M vaccines for ID administration was started without the due written permission of the vaccine manufacturers. On 9 March, 2007, the written permission from both manufacturers was obtained.
Also, it was ordered by the Director General of Health Services, U.P. via order no. IlF/406 dated 26 March, 2007 and by the Government of U.P. through order no. KRAI-Ka-03/5-1-2007 -4(B)/07 dated 24 April, 2007, that one doctor from each district's each ARC and two pharmacists or nurses from the same had to be well-trained under Dr. M. N. Siddiqui (Nodal Officer for Rabies in U.P.). It is expected that by July 2007, pharmacists from all districts would have been trained and IDRV will be started at all places. A problem faced during the training is the reluctance of the doctors from several districts to come for training and taking part in the programme. In the second phase, pharmacists of Community Health Centres will be trained from October 2007 onwards.
Though IDRV has its benefits, yet it has its own limitations. They are as follows:
Firstly, under no circumstances should vaccines be administered intradermally by any person other than a trained staff member of ARC. This condition is strictly in accordance to WHO guidelines as well as D.C.G.!.. Any violation is punishable by the court of law.
Secondly, it should be understood that for immune compromised people, persons on immunosuppressant drugs or therapy, people suffering from malnutrition or from Diabetes Mellitus of a long duration etc. and people who are expected to have a poor immune response, the use of 1M route for 2 administration of ARV is strongly recommended.
Thirdly, if ID dose is given sub-cutaneously, then there is a possibility of a poor immune response due to low antigen load. This is very dangerous and may lead to death. Care should thereby be taken that whenever no characteristic change in skin is noted at the site of administration, the patient should receive 3 another dose of the vaccine near to the site.
Also, it has been recommended in a letter issued b~ the DCGI (letter no. Xll026/23/05-D dated 20 October, 2006) that with the approval of competent authority and ICMR, the condition of the unit dose of O.lml of TCARV having potency of 2.5 IU/IM dose may also be read as "For use with PVRV (O.5ml vials) one fifth dose of minimum 0.5 IU/ID dose. For PCECV and HDCV (1 ml vial) minimum of 0.7 IU potency per O.lml or O.2ml. This is as per the Thai CDC recommendation except that we have added o .2ml at the end".
In a vast nation like India, health is a state issue. Thus, each state has its own policies. For the proper prevention of the fatal disease, rabies, it is necessary that national guidelines be put down to be followed alike by all states. It is, thus, hoped that in the upcoming meeting of the expert group at NICD, New Delhi on 29th May, 2007, these national guidelines would be clearly finalised, which should be inclusive of the following:
From 19th May, 2006 to 18th May, 2007, a total of 13752 animal bite cases have been treated by using IDRV at Balrampur Hospital, Lucknow. As an indicator to the success of IDRV is the fact that there has been no report of even a single vaccine failure case in the state of U.P.
Even though IDRV was successfully started in U.P a year back, it is saddening that IDRV has yet not found its due place in other states. At this juncture, it is a great pleasure to acknowledge the efforts of the ARC of MKCG Medical College, Behrampur, Orissa and specially Dr. Durga Madhab Satapathy, to take to IDRV ever since 25 April, 2007. Every care should yet be taken for implementing IDRV as there is never a second chance with rabies.