Flawed National guidelines for rabies prophylaxis and use of Intradermal Anti Rabies vaccine

[Guest guest]

Dear Friends,

Government of India now has come up with

latest guidelines by NICD on Antirabies prophylaxis,

but paradoxically again these guidelines say that

" The vaccine package leaflet should include a

statement indicating that the

potency as well as immunogenicity and safety allow

safe use of vaccine by

ID pre- and post-exposure. "

Again the guidelines are in the hands of the vaccine

manufactureres as until they write in heir package

insert that the vaccine is fit for I/D Route, we can

not give it!

This is the mockery of the intradermal order of DCGI,

why not the DCGI forces these companies to write in

the insert for intradermal use also?

Again fight need to continue until DCGI does that.

Please suggest.

Dr. Omesh Bharti, Himachal

 

A clip is beelow:

 

General guidelines for use of IDRV (NICD)

& #61548; Vaccines to be applied by intra-dermal route

of administration should be

approved by DCGI.

& #61548; The vaccine package leaflet should include a

statement indicating that the

potency as well as immunogenicity and safety allow

safe use of vaccine by

ID pre- and post-exposure.

& #61548; Post Marketing Surveillance (PMS) data should

be maintained for minimum

of two years by vaccine manufacturers on a

pre-designed and approved

protocol.

& #61548; Intra-dermal injections must be administered

by staff trained in this

technique.

& #61548; Vaccine vials must be stored at 2º to 8ºC

after reconstitution.

& #61548; The total content of reconstitute vial should

be used as soon as possible,

but at least with in 8 hours.

& #61548; All the reconstituted vaccines should be

discarded after 8 hours of reconstitution at the end

of the day.