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DOTS
norms to be adhered, irrational FDC may go
Jayashree
Padmini - New Delhi
Aligning
with WHO guideline and in a bid to check the irrational prescription
habits in TB treatment the government has decided to enforce the
DOTS protocol strictly. The fixed dose combination (FDCs) of the
four anti-TB drugs, viz., Rifampicin, Isoniazid, Ethambutol &
Pyrazinamide would be accepted as the standard treatment protocol,
said Dr C P Thakore, in an exclusive interview to Express Pharma
Pulse.
The
Drug Technical Advisory Board has given the go ahead in this regard
and there would be a complete shake out in the anti-TB drugs market
with the enforcing of phasing out of other FDCs that would be effected
in a one-year period, said sources in DCGI. A standardized specification
for FDCs is being worked out now and this is determined by the study
conducted at Niper to this end.
Apart
from anti-TB FDCs others are also under scrutiny of the regulatory
authority and the government, keen to weed out irrational formulations
has initiated steps in the direction of identifying such drugs.
The issue will come for discussion in the next Sub Committee meeting
scheduled for June this year, said the source. This aims at assorting
the fixed dose combinations (FDCs) where the therapeutic efficiency
is in doubt and to classify them as irrational thereby paving way
to remove them or restructure these combinations, said the source.
DCGI
Ashwini Kumar when contacted said that this issue is a matter of
debate as well as a continuous process and the authority would give
manufacturers an opportunity before completely phasing out the formulation
to work out a rational formula. An additional drug in the combination
increases the risk of side effects unwarranted for apart from increasing
direct cost to the ultimate user.
To
address the concern on the TB front, the government is planning
to hold an expert seminar to deliberate on the different issues
such as bioavailability, patient compliance levels, irrational FDCs,
etc., where apart from experts in the field industry representatives
will be participating, said the Health Minister.
Framing
a reliable strategy on anti-TB drugs became imperative ever since
the bioavailability studies conducted at the National Institute
for Pharmaceutical Research & Education (Niper) and LMCP, Ahmedabad,
were out. Bioavailability is the rate at which and the extend to
which the active drug molecules are available in the blood for absorption
at the cite of action.
According
to latest estimates an additional two million cases are being reported
every year in the country. Multi drug therapy is recommended in
TB treatment to avoid the risk of developing multi-drug resistant
(MDR) TB. DOTS is an acronym for Directly Observed Treatment, Short-Course,
in which TB patients must be observed swallowing each dose of their
anti-TB medicines by a health worker or trained volunteer, and their
progress must be monitored, in order that they be cured and not
pass on the infection to others.
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