E-DRUG: FDC antibiotics in India: global perspectives: The Lancet Global Health
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Dear All,
Sharing a important article on an Important debating Issue In India about
344 Fixed Dose Combinations (FDCs) Banned recently, antibiotics, resistance
and its global implications" Fixed-dose combination antibiotics in India:
global perspectives" from “The Lancet Global Health” by
Akram Ahmad, Muhammad Umair Khan, Rajesh Balkrishnan
On March 10, 2016, the Indian Government banned around 330 'irrational'
fixed-dose combination drugs (FDCs) with immediate effect. FDCs are
products that contain two or more active drugs in a fixed-dose ratio, and
are useful for minimising pill burden and lowering cost. However, FDCs
should ideally contain constituents that act via different mechanisms and
do not cause additive toxic effects. An FDC is described as irrational if
these conditions are not met. The government's decision was influenced by
reports expressing concern about the safety and efficacy of FDCs
manufactured in India.1, 2 In view of the substantial financial loss to
industry, some pharmaceutical companies have taken legal action to exempt
their FDCs from the ban. However, we believe the government's action was
necessary to safeguard public health.
63 (19%) of the 330 banned FDCs are antibiotics. Antibiotic resistance is
of increasing concern worldwide, but initiatives to curtail inappropriate
use have had little success. Studies of several antibiotic combinations,
such as meropenem and sulbactam, have reported no additional advantage over
their individual constituents, and have been reported to cause toxic
reactions and promote resistance.3 Despite repeated investigations into the
shortcomings of some FDCs, such drugs are still being manufactured and
promoted on the Indian drug market. 118 antibiotic FDCs are available on
the Indian market, 80 (68%) of which are not registered with the Central
Drugs Standard Control Organisation.1
The regulation of FDCs of antimicrobials in India is important from a
global perspective. The growth of worldwide trade and travel has allowed
resistant microorganisms to spread rapidly to distant countries and
continents. New Delhi metallo-β-lactamase, an enzyme that causes bacteria
to be resistant to antibiotics, was first reported in India in 2008 and is
now found worldwide.4 Moreover, FDCs that have been banned in India have
been reported to be exported to other African and Asian countries.5 Such
exports are a setback for the individuals or organisations trying to
implement antimicrobial stewardship initiatives in these settings.
Inadequate knowledge of physicians about FDCs is also an exacerbating
factor in antibiotic resistance.
The Indian Government has taken a much-needed step to restrict antibiotic
resistance by banning irrational FDCs. Since implementation of the ban is
still pending, we urge the international community to support the Indian
Government's initiative to ensure full implementation of the ban on
irrational FDCs, because controlling antibiotic resistance in India is key
for controlling antibiotic resistance worldwide.
Full Text:
http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(16)30093-6/fulltext
Researchgate:
https://www.researchgate.net/publication/305401953_Fixed-dose_combination_antibiotics_in_India_global_perspectives
Kind Regards,
Akram Ahmad, PharmD, BPharm
Department of Clinical Pharmacy,
UCSI University, Kuala Lumpur, Malaysia
akram ahmad <akrampharma67@gmail.com>