PHM-Exch> Fixed dose combination medicines (FDCs)

[Claudio Schuftan]

From: Gopal Dabade <drdabade at gmail.com>


http://pharmabiz.com/NewsDetails.aspx?aid=67408&sid=1

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*Planning Commission panel calls for sterner regime on FDCs*

*Joseph Alexander, New Delhi*
*Wednesday, February 08, 2012, 08:00 Hrs  [IST]*

Even as the industry is still discontent with the authorities on the issue
of Fixed Dose Combinations (FDCs), an expert panel of the Planning
Commission has called for stricter criteria for registration and regulatory
review of FDCs by the Central Drugs Standard Control Organisation (CDSCO)
with a view to weed out irrational FDCs.

“Irrational FDCs, non-essential vitamins/tonics, cough syrups feature in
the top selling pharmaceuticals in terms of value and volume but they harm
public health and patients by increasing adverse effects, imposing higher
financial burden on patients and facilitating - emergence of drug
resistance (in the case of FDCs of antibiotics). Therefore, stricter
criteria for registration and - regulatory review of medicines by CDCSO
should be a priority. This helps weed out substandard, toxic, irrational
medicines from the market,” a working group of the Commission said.

It suggested that CDSCO should implement a much stricter registration
regime for FDCs. Products should be selected and approved only when the
combination has a proven advantage in therapeutic effect, safety, adherence
or in decreasing the emergence of drug resistance in malaria, tuberculosis
and HIV/AIDS, the panel said.

“Except FDCs included in the WHO’s essential Drug List, all FDCs registered
in India are reviewed in terms of their therapeutic effect and legally
sustainable action taken for phased out weeding of all irrational FDCs. The
Drug Technical Advisory Board should set up a suitable mechanism for the
purpose,” it said.

FDCs have been at the centre of a vexed controversy for over four years
now. The lack of concrete rules largely led to the confusion and
confrontation between the authorities and the industry, after the DCGI
sought to weed out the irrational FDCs from the market.
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