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The Hindu
A fixed dose combination is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form. Photo: Karishma Anand.
[h=2]Many unapproved FDC formulations contain banned, restricted, or never approved drugs[/h]
Millions of unapproved formulations and products of fixed dose combinations (FDCs) available in India in three therapeutic areas — analgesia, anxiety/depression and psychosis — are unsafe and at times dangerous or even lethal, as in the case of anti-psychotic. In contrast, 98 per cent of metformin FDCs to treat diabetes has been approved by the Central Drugs Standard Control Organisation (CDSCO).
Approval by CDSCO has been made mandatory for FDCs since 1961. Several amendments to the rules, particularly the last one in 2002, have only made it explicitly clear. Yet, the proportion of unapproved FDC formulations did “not decrease overall” after May 2002.
A fixed dose combination is one that contains two or more drugs combined in a fixed ratio of doses and available in a single dosage form.
“Multiple formulations [in the four therapeutic areas studied], most without CDSCO approval [for efficacy and safety], included drugs banned, restricted, or never approved internationally owing to adverse effects,” notes a paperpublished last week in the journal PLOS Medicine. Over 12 per cent of nonsteroidal anti-inflammatory drugs (NSAID) FDCs sales volume contain drugs that have either been “withdrawn” from the market or have had their “use restricted.”
Also, many NSAID FDCs available in India contain muscle relaxants and enzymes that have been approved as a single dosage form in the U.S. and UK but never as a fixed dose combination.
“Most of the FDC formulations available in India [in the four therapeutic areas studied] were unavailable in either UK or the U.S.” the authors note.
The study by Patricia McGettigan from the London School of Medicine and Dentistry, London and others also found that even in the case of approved formulations and products, “numerous” FDCs were marketed “before the CDSCO approval date.” Worse, since 2001, the CDSCO has approved some new drugs even “without clinical data” for efficacy and safety. And the grounds on which approval has been granted are not published.
With pharmacovigilance being at a nascent stage and reporting of adverse events being low, the absence of information on adverse effects of even approved FDCs, therefore, does not mean they are safe.
“Unapproved formulations should be banned immediately, prioritising those withdrawn/banned internationally,” the authors recommend.
This is the first time an empiric study of FDCs available in India has been undertaken.
India flooded with unsafe fixed dose combination drugs - The Hindu
