[e-drug] Public hearings on drugs (cont)

E-drug: Public hearings on drugs (cont)
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Friends,

Regarding Charles Medwar's query on public hearings on drugs with
unacceptable risks, there has been one instance of the same in India. The
group of drugs in question were high dose combinations of estrogen and
progesterone. A large number of such combinations were being marketed in
India with various indications -- prominent among them being threatened
abortion. Curiously these drugs acquired the reputation of being
abortifacients (to be fair this was not listed by any of the manufacturers).
But because of the reputation these drugs were widely being used during
pregnancy with the (mistaken) belief that they could induce abortions. Over
the Counter sales of these drugs was rampant.

The issue was raised by a number of consumer groups and women's groups. The
principal arguments raised for banning of the combinations were that: a)
they were being widely misused; b) no medical indications exist for their
use; c) their use in pregnancy was known to be associated with birth
deformities, especially neural tube defects.

Initially drug companies opposed these claims and carried out an aggressive
counter-campaign, where they enlisted the support of a number of
"prominent"doctors as well as the support of the Federation of
Obstetricians and Gynaecologists In India (FOGSI). However finally in
1988, the Drug
Controller ordered that public hearings be held in four cities -- Calcutta,
Bombay, Delhi and Madras. The hearings were extremely acrimonious and
activists groups pointed out a number of instances of blatant collusion
between the industry and FOGSI members. Activists groups held demonstrations
outside the centres where the hearings were being held. Finally in end 1988
the combination was banned by the Government.

Dr.Amit Sen Gupta
National Campaign Committe for Drug Policy
D-158, Saket, New Delhi - 110 017, India
email: ctddsf@vsnl.com
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