The use of the Sheep Brain derived Nerve Tissue Vaccine [NTV] used for post-exposure anti-rabies prophylaxis in the numerous Anti-Rabies Clinics [ARC], in Government (Govt.) Hospitals and Health centers in India has come to an end by the end of September 2005. The change was very much desired, but it had to be gone about in a phased manner. I was advocating this theory for the last several years in various platforms, in my presentations and papers. I still maintain that the change should have been in a phased manner of gradual stepping down of NTV production and usage, followed simultaneously by increased production of TCV and its usage, in a phased manner. The results of not following this procedure is very clear, everyone can see it. However, the very powerful, who are actually responsible for the chaos will never suffer, as always. It is only the poorer and weaker sections of the society, who are suffering.

The modern Tissue Culture Vaccines [TCV] are in use for both pre and post-exposure prophylaxis against rabies for more than two decades. The advantage of using TCVs are visible to both the physicians treating an animal bite victim and the patient receiving it . Without Govt. support, about half of the total number of patients, who are receiving post exposure vaccination against rabies, take TCVs as revealed by the APCRI WHO Survey 2004. All of these patients were taking TCVs in "ESSEN" schedule the only schedule approved by the Drug Controller General of India [DCGI], for Intra Muscular [1M] route of administration. This schedule is very easy to administer and does not cause any problems for the recipient, it is highly immunogenic and has a good margin of safety. The cost of the five doses of TCV to be used for a full course is considered by many State Govts funding the programme in their respective states to be beyond their means.

The availability of adequate amount of TCVs for use in Govt Hospitals and Health centers 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 10" 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 IORV in 1992, about 15 years ago. It is considered as an ethical and cost-effective replacement of NTV. Besides IORV is generally considered as, a "pro-poor" vaccination.

The Drugs Controller General of India [DCGI] has so far issued three directives one each on February 2006, August 2006 and October 2006, 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 five of the eight commercially available vaccines against rabies [which can be used by 1M route], to be used by the 10 route also.

The "TRC ID"schedule[2-2-2-0-1-1] and the modified "TRC lO"schedule[2-2-2-0-2-0] are the only two routes approved by the DCGI. The dose of each ID shot has been specified to be of 0.1 ml of the permitted vaccines [in some cases it can be 0.2 ml of the vaccine, or 115 of the 1M dose, depending on the potency].

The ID route has been permitted to be used in selected anti-rabies clinics having an attendance of a minimum of. 10 patients per day for post-exposure vaccination against rabies. These clinics should have an appropriate number of adequately trained staff for 10 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 1M route the regulatory guidelines are not different in different countries. In every country the minimum potency of each vial of a single 1M 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 is 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 IV/ ID dose and in the Philippines the potency requirement is 0.5 IV/ ID dose.  

The National Workshop on Rabies Prophylaxis was held over two days, 9th & 10th December, 2006, at Alappuzha, in the state of Kerala. The National Workshop was organized jointly by the APCRl and the Department of Community Medicine of T. D. Medical College, Alleppy. One of the conclusions from the workshop was that in "Intra Dermal Rabies Vaccination [IDRV]", the confusion created by multiple directives from the Drugs Controller General of India, was highlighted. It was felt that the "WHO Expert Consultation on Rabies, TRS 931" be followed and inputs from the ICMR study report be incorporated in it for making IDRV suitable for use in India.  

The use of the 10 route for post-exposure prophylaxis against rabies will reduce the vaccine requirement to a great extent. The cost of implementing the vaccination programme will be much less for the funding agencies, usually the Government. TRC-ID schedule has been implemented in Thailand, the Philippines, and in Sri-Lanka in many hospitals (not all). These are small countries but India is a huge country. Here ID usage has to be started in a phased manner. The difficulties encountered in each step can be rectified in the next.

In the race to start ID vaccination it is very important to remember that the Intra Muscular (1M) 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.  

Uttar Pradesh is the first state in India, to start IDRV. IDRV was started there from 19th May 2006. Dr. M. N. Siddiqui, is the first doctor to start IDRV officially in a Govt. ARC in India. He did it at the ARC of the Balrampur Hospital in Lucknow.  

From 19th May, 2006 to 18th May, 2007, a total of 13752 animal bite cases have been treated using IDRV at the ARC of 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 From May 2006 to April 2007 , deaths due to rabies reduced significantly in the Lucknow district, where IDRV was implemented first. This was due to the use of IDRV, in the animal bite patients who approached the Anti­Rabies Clinic at Balrarnpur Hospital, Lucknow. This decrease was not due to the superiority of intradermal administration over intramuscular administration, but because now the same number of vaccine vials could be used to administer vaccine to a larger number of patients. Although the Uttar Pradesh Government allocated an annual budget of 30 crores rupees for rabies vaccination dur ... "1g the last financial year, yet there had been a sho:-:age of vaccines, in the past. IDRV implementation helped in overcoming this shortage.

The Govt. of the state of Uttar Pradesh is determined to implement IDRV at various tiers of its health care delivery system. It has a very bitter experience of facing acute shortage of vaccines resulting in its unavailability in its ARCs. The patients from the weaker sections of the society were the ones to suffer most. The Director General of Health Services, V.P. has ordered 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. In the second phase, pharmacists of Community Health Centres are to be trained from October 2007 onwards.

Orissa is the second state to start IDRV, after Vttar Pradesh. The Intra Dermal Rabies Vaccination [lDRV] has been started at the ARC of MKCG Medical College, Berhampur on 25th April, 2007. The ARC of MKCG Medical College, Berhampur is the first center in the state of Orissa to start IDRV. Dr. Durga Madhab Satapathy and his team have started IDRV in Orissa with the guidance and blessings from Prof. Trilochan Sahu, Head, Department of Community Medicine, of MKCG Medical College, Berhampur.

The ARC of MKCG Medical College is the first center to implement IDRV in the state of Orissa. The procedure will be implemented at the ARCs of the three Govt. Medical Colleges and the Capital Hospital at Bhubaneswar, in the next phase. Subsequently after due training of the related health professionals, the procedure will be carried out at all of the 30 District Hospitals, located in the respective District Head Quarters towns.

After the introduction of IDRV in Uttar Pradesh and Orissa, it will be introduced shortly in Andhra Pradesh. IDRV introduction will enable more number of patients to receive the full course of vaccination and will also decrease the economic burden on the governments.