[e-drug] Intra-dermal use of anti-rabies vaccine? (3)

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

Dear all,

The use of Intra Dermal (ID) route has been well accepted. It has been
recommended by WHO since 1992 and has been extensively used in Thailand. The
brand 'Rabipur' marketed by 'Aventis' (but produced by Chiron Bevis
Vaccines') has been registered for ID route also in the West and the 2002
WHO document specifically mentions Rabipur for the ID regimen! But the same
company's same Rabipur contains "for intramuscular use " on its label and
the company has not been promoting the ID route here in India - a classical
case of double standards. The question is can Indian Drugs Controller/govt.
force Aventis to include ID route in its label in India. If Aventis agrees
to apply for the ID route also, would that require fresh Indian clinical
trials even if it is the same company, same product, same brand? Aventis is
obviously not interested in putting the ID route in its label. But without
such a label, ID use is at the discretion/responsibility of the doctors. The
Govt. doctors are not ready to take the onus for this off label use so the
question - "can Indian Drugs Controller/govt. force Aventis to include ID
route in its label in India" is important. Can anybody clarify this ?

With Warm Regards
Sincerely Yours,

Dr.Anant Phadke.
Peoples's Health Movement
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