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Globally, lots of changes have come and some are coming in the field of rabies prophylaxis. The use of Nerve Tissue Vaccine has stopped in India and Nepal. It is scheduled to stop in Vietnam in 2008. Bangladesh and Pakistan are our only neighbours who continue to use it in their free clinics. In India, Intra Dermal Rabies Vaccination (IDRV) had started on 19th May, 2006. We must give credit to Dr. M. N. Siddiqui and the Health Department of the Govt. of Uttar Pradesh for making it possible. In fact, there were no official Ruidelines available, when it was started. In fact, the history of mankind has numerous examples of pioneering acts by very courageous persons. Dr. M. N. Siddiqui is a pioneer and he is our hero. Then onwards IDRV has been implemented in Orissa, Andhra Pradesh and in West Bengal. IDRV is being given in selected centers only. World Rabies Day was celebrated through out the world, for the first time, on 8th September, 2007 with the objective of increasing the awareness about rabies, of the people of the world. On this date in India also, a lot of activities took place. At the National Institute of Communicable Diseases (NICD) in Delhi, the National Guidelines for Rabies Prophylaxis and Intra-dermal Administration of Cell Culture Rabies Vaccines was released. This is the first time that India has a National Guidelines on Rabies Prophylaxis in the form of a booklet. This was very essential. The availability of adequate amount of TCVs for use in Govt Hospitals and Health centers in India is a problem at present, and will remain a problem, in the immediate future, in many states. If only "ESSEN" schedule is used for post-exposure prophylaxis against rabies then the crisis will be more acute. The number of vials of vaccine required for a course of vaccination will be more, if the ESSEN schedule of vaccination is used. If, the"TRC ID" schedule [2-2-2-0-1-1] or the modified "TRC ID" schedule [2-2-2-0-2-0] is used then the total requirement of vaccine vials will be less than that for the "ESSEN" schedule. Not All, vaccines produced in INDIA are at present fit for ID usage as per facts revealed in some studies, and the "WHO Expert Consultation on Rabies", Technical Report Series 931, and the directives from the DCGI. The WHO had approved IDRV in 1992, about 16 years ago. It is considered as an ethical and cost-effective replacement of NTV. Besides IDRV is generally considered as, a "pro-poor" vaccination. The Drugs Controller General of India [DCGI] has so far issued directives regarding the regulatory guidelines for Intra Dermal Rabies Vaccination [IDRV] in India after detailed consultations with Experts Group, the Competent Authority, and the ICMR. The Drugs Controller General of India [DCGI] has allowed the use of only three of the seven commercially available vaccines against rabies [which can be used by 1M route], to be used by the ID route also. The modified "TRC ID"schedule[2-2-2-0-2-0] is the only route approved by the DCGI. The dose of each ID shot has been specified to be of 0.1 mi of the permitted vaccines. The ID route has been permitted to be used in selected anti-rabies clinics having an appropriate number of adequately trained staff for ID inoculation. These centers should be able to maintain cold chain for vaccine storage and be able to ensure adequate supply of suitable syringes and needles for administration by the ID route. These centers should be well versed in the management of open vial and safe storage practices. In the case of vaccines being used by IM route the regulatory guidelines are not different in different countries. In every country the minimum potency of each vial of a single IM dose of TCV or AEV is 2.5 IU. Only three countries are practicing IDRV in regular patients attending regular anti-rabies clinics. These countries are Thailand, the Philippines and Sri Lanka. IDRV is being practiced in . those countries for more than a decade. It would be very much logical and rational for the regulatory authorities in India to follow the regulatory guidelines prevalent in Thailand, the Philippines and Sri Lanka, and then decide what to implement in India. In Thailand and in Sri-Lanka, the potency requirement is 0.7 IU/ ID dose and in the Philippines the potency requirement is 0.5 IU/ ID dose. In the race to start 10 vaccination it is very important to remember that the Intra Muscular (IM) route is the preferred route for anti-rabies vaccination using modern TCVs or modern Avian vaccines in the immune compromised persons, persons on immunosuppressant drugs or therapy and on chloroquine therapy. Persons suffering from Diabetes Mellitus of a long duration, persons having malnutrition, and many other medical illnesses, where the patients are expected to have a poor immune response, the use of ID route for post-exposure prophylaxis against rabies, can be very risky. If ID dose is given sub-cutaneously (SC) then there is a possibility of poor immune response due to low antigen load. This may be life threatening. WHO recommends in cases where the characteristic change in the skin over the injection site has not appeared, the patient should receive another dose of vaccine at a site nearby where the characteristic change in the skin over the site of the shot, appears. The WHO has released its latest position paper on Rabies in the Weekly Epidemiological Record dated 7th December, 2007. It has advised that prior to administering ERIG, the Intra-dermal skin test is not required. In Pre-exposure Rabies vaccination, where serological testing is unavailable, it has asked for booster vaccination every 5 yearly. All changes are very good if they can provide more safety and tolerance to the patients. However, changes which endanger the lives of the unsuspecting patients seeking treatment, or are tools for ego boosting or lobbying among the various groups involved in power play, are not desirable. I believe that in the long run truth will prevail. |