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CDSCO for approval and rejection of FDC. But there are so many things need to be
improved and CDSCO should join hands with all stake holders including manufacturers and
regulatory consultant.
BOX ITEM
This time CDSCO should invite all stake holders as how to reply back periodic safety update
report and clinical trial phase-4 protocol and executive summary. It would be nice enough for
stake holders if CDSCO organise workshop and call them to know in brief about as how to
write protocol for phase-4 clinical trials and executive summary so that they can respond the
query fearlessly. Most of the manufactures are not aware about periodic safety update report
(PSUR) then how come they will submit reply. In India, Pharmacovigilance is in a very
nascent stage but it is need of hour to implement in a very strong way.
The development of fixed-dose combinations (FDCs) is becoming increasingly important
from a public health perspective. Such combinations of drugs are being used in the treatment
of a wide range of conditions and are particularly useful in the management of HIV/AIDS,
malaria and tuberculosis, which are considered to be the foremost infectious disease threats in
the world today. According to USFDA, The rationality of FDCs should be based on certain
aspects such as, the drugs in the combination should act by different mechanisms, the
pharmacokinetics must not be widely different, the combination should not have supraadditive toxicity of the ingredients and there should not be drug-drug interaction.
Noteworthy without clinical trial it is not possible to confirm whether any combination drug
is rational or irrational. It is only possible after clinical to confirm pharmakodynamic (Mode
of action), pharmacokinetic (absorption, distribution, metabolism & excretion), drug-drug
interaction and additive supra adverse effects.