Number 40 - Indian Pharmaceutical Association

Clarithromycin use may be linked to
increased risk of miscarriage
MedPage Today reports, "Use of the
antibiotic clarithromycin (Biaxin) in the
first trimester of pregnancy is associated
with an increased risk of miscarriage,"
according to a study published online in
PLOS ONE. Researchers found, "in a large
cohort study," that women "who took the
drug in the first trimester were 56% more
likely to miscarry than those who did not
take the drug." However, there was "no
increase in the risk of birth defects."
treatment or monitoring, resulting in
fatalities.
The drugs have been used on thousands
of adolescent girls in Gujarat and Andhra
Pradesh, they said. "These vaccines had
not been assessed with respect to safety
and efficacy for the Indian population,
where adolescent girls are
overwhelmingly anemic and
malnourished. No steps were taken to
ensure the health and safety of the girls,"
the petitioners said.
Supreme Court notice to
Government on PIL over marketing
of Gardasil and Crevarix vaccines
The Supreme Court has issued a notice to
the government on a plea that licences
for sale and marketing of Gardasil and
Crevarix, vaccines for prevention of
cervical cancer, should be revoked as the
drugs are "unsafe" and the permits were
granted without adequate research.
Gardasil and Crevarix, both human
papilloma virus (HPV) vaccines, are being
marketed in India by MSD
Pharmaceutical, a subsidiary of Merck,
and GlaxoSmithKline, respectively.
"Both vaccines were licensed in India
without sufficient clinical trials in
appropriate age groups to determine their
safety and efficacy," the public interest
litigation (PIL), filed on behalf of an
Andhra Pradesh-based women's
organisation, said.
Seeking a ban on their sale and use,
petitioners Kalpana Mehta, Nalini Bhanot
and V Rukmini Rao alleged that the
drugmakers were "conducting trials" on
unsuspecting women from vulnerable
sections of the society without follow-up
The PIL claimed that the Parliamentary
Standing Committee for Health and
Welfare had sought a probe into the
approval for marketing of these vaccines
but "this was not done". According to the
PIL, the Indian Council for Medical
Research had entered into an MOU with a
US-based NGO to execute a project to
test the drugs.
Source: Economic Times
Indian Government plans new
legislation to take DPCO out of
Essential Commodities Act ambit
The government is planning to bring a
new legislation to modify and place the
Drugs Price Control Order (DPCO)
separately from the ambit of the Essential
Commodities Act.
However, the new legislation is unlikely to
be presented in the Budget session of
Parliament and the Department of
Pharmaceuticals (DoP), hence, would
notify the revised DPCO before the
session, it is learnt. The new DPCO will
lay out the retail price of over 640 packs
of 348 essential medicines.
“The National Pharmaceutical Policy was
already notified and to define the
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