[e-drug] Intra-dermal use of anti-rabies vaccine?

["Amol" <amol_p@vsnl.com>]

E-DRUG: Intra-dermal use of anti-rabies vaccine?
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[WB]

Dear all,

Since the Semple vaccine has been withdrawn in India, we are lobbying for the use of Intra-Dermal use of the Cell Culture Vacine -PCEV - as Intra Muscular PCEV course is five times costlier than the Semple vaccine course.  But the drug companies have put 'for intramuscular use only' on the label. This is despite the fact that the intra-dermal (ID) use has been recommended by the WHO and is being mentioned in the Park's textbook of PSM, which is widely used & taught in India. The govt officials are not ready to give the ID regimen as Rabipur label says 'for IM use only.'  ("Rabipur" is one of the leading brands). Can anybody suggest any way out? 

Is the ID formulation available in the West different than the IM one in its content? Can the FDA compel the manufaturers to add 'for intradermal use' on their label? Can govt. decide to go ahead by asking their Chief Medical Officers to give permission/instruction to use It intra dermally with a 'off label' use strategy? 

Currently most patients in govt. hospitals have to buy Rabipur as govt says it can not afford to increae its budget on ARV !
 
With Warm Regards
Sincerely Yours,
Dr. Anant Phadke.
People's Health Movement in India
 
Anant  & Sandhya Phadke,
8, Ameya Ashish Society,
Kokan Express Hotel lane,
Kothrud, Pune 4110038
phone - 020 25460038,  020 21712241
 
Pl. visit the mfc website - at www.mfcindia.org 

[Moderator's comment: Drug Regulators can only change a route of administration (ID rather than IM) if the manufacturer requests that route and provides proof of efficacy and safety. Drug regulators will be very reluctant to change labels without good scientific evidence. Is that available?

Obviously the manufacturer is not responsible if doctors start using their products in a non-recommended way ("off-label"). Off-label use is very common (e.g. paediatrics) but doctors are liable and should inform patients about the off-label use. 

Best way out seems me that evidence of intradermal efficacy & safety id provided to the DRA by the manufacturer, but he will not be eager to sell 5 times less volume of the same product... 

Any e-drugger who knows about intra-dermal use of rabies vaccine versus intramuscular? Wilbert Bannenberg, co-moderator]