doi:10.1038/nindia.2015.78 Published online 13 July 2015
New research has unearthed severe irregularities in the way fixed dose combination (FDC) drugs are sold in India1.
Evidence of rampant sale of drugs not approved by CDSCO (Central Drugs Standard Control Organization), India’s national standard body for pharmaceuticals and medical devices, has been found by a team of researchers from Mumbai, Pune and London. They studied four distinct categories of drugs used for pain relief, diabetes control, anxiety/depression and psychosis.
Two or three active drugs are combined to make an FDC pill. FDCs have lower manufacturing costs, simpler logistics of distribution, improved patient adherence and reduced resistance development for antimicrobials, according to WHO. The international health body also lays out clear guidelines on how and when new FDCs can be introduced in the market.
The authors studied the volume of sales of FDC drugs in these categories between 2007 and 2012. They also examined data from 2011-2012 to find the number of formulations in the market in each category, with or without CDSCO approval.
Of all the the formulations available in the market, unapproved formulations amounted to 73% in NSAIDs, 20% in diabetes control, 81% in anxiety/depression and 70% in psychosis. Each of these formulations give rise to multiple drugs, each with a different brand or trade name. The proportions of FDC sales volumes arising from unapproved formulations were 28% in NSAIDs, 0.4% in diabetes control, 69% in anxiety/depression and 43% in psychosis.
Across the four drug categories, the team studied 175 formulations. They found that only 14 FDC formulations were approved in the UK and 22 in the US. Astonishingly, some of the formulations being sold in India were banned in other countries. For example Nimesulide, an NSAID banned in multiple countries, was available in India in 15 FDC formulations, of which only one is approved by CDSCO. Thioridazine, an anti-psychotic withdrawn worldwide in 2005, was found in one unapproved FDC being sold in India.
The authors say ambiguity in legislature was fueling this trend of rampant sales of unapproved drugs. Analyzing why doctors prescribe such drugs in the first place, a 2013 study evaluated 100 resident doctors. It found that knowledge about rationality of FDCs was lacking in 81% of the resident doctors2. Only 47% could name a single banned FDC in India. Last year, another team of researchers had also interviewed dental clinicians to find out that only 47% residents and 58% dental clinicians could recall a single banned FDC in India3.
In 2007, CDSCO banned 294 FDCs because they had never been approved by CDSCO but were cleared for sale and manufacture by state authorities. The manufacturers contested the ban and obtained a stay order from the Madras High court. All the banned drugs are being sold in the market.
The authors recommend a phased withdrawal of all these banned and unapproved drugs. They also call for increased transparency and accountability of regulatory decisions.