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‘Violation of DCGI directive cause for shortage of anti rabies vaccine’

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Express News Service

Posted: Jul 21, 2008 at 0224 hrs IST

Pune, July 20 The Jan Arogya Abhiyan has pointed out that the shortage of the anti rabies vaccine is due to the non implementation of the directives of the Drugs Controller General of India (DCGI) that the vaccine can be given intra-dermally -- within the two layers of the skin.

A year has passed since the DCGI has instructed the states to administer the vaccine via the intra-dermal route. However, Maharashtra is yet to implement it.

Given intra-dermally only the 0.2 ml of this vaccine is sufficient compared to one ml that is given in the muscle. The organisation has pointed out that if the intra-dermal route is adopted then five times as many dog bite cases can be treated in the same budget.

A statement issued by Dr Anant Phadke, co-convenor of theAbhiyan said that this Intra Dermal Route has been recommended by World Health Organisation since 1994 and by standard medical text books. In US, even special ampoules containing 0.1 ml of this vaccine for intra- dermal Route is also available.

But in India, the same multi national company has mentioned only the intra-muscular route in its literature and has suppressed the option of the intra-dermal route. In Thailand, for many years, thousands of dog bite cases have been treated with this intra-dermal route. Continued use of intra-muscular route of this costly vaccine (Rs. 250 per cc) has resulted in denial of Anti Rabies Vaccine to thousands of poor because the very limited budget for this vaccine cannot accommodate all such patients. While, the organisation has complained to the National Human Rights commission in March 2005 and done a consistent follow up, the Drugs Controller General of India had issued directives approving the use of the intra dermal route for this vaccine. A year since the directives were passed, Maharashtra has yet not adopted the Intra Dermal Route.

The Abhiyan has demanded that the concerned authorities stop being callous about providing treatment to all dog bite cases in public health facilities and immediately adopt the scientifically well-established intra- dermal route.

All drug companies should be ordered to immediately include in their label the clause "for intra- dermal route". Research has shown that even if the vaccine is mistakenly given below the skin it is equally effective. There should not be any more delay under any pretext for adopting the intra-dermal route.

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