The WHO has stated that 10% of the medical products available commercially in low- and middle-income nations is spurious, i.e., substandard or fake. As a result, patients consuming such medicines fail to treat their ailments optimally, wasting money in the bargain. This means the illness stays for longer, thereby affecting productivity. And in case of substandard antibiotics, this ups the risk of drug resistance. WHO analysis finds that antimalarials and antibiotics are the most commonly faked. Given malaria and other infectious diseases exact a greater toll from developing and poor nations, poor quality drugs compound the disease burden in these countries. While the highest incidence of substandard drugs is in the WHO’s African region, WHO American and European regions follow. The WHO South-East Asian region, of which India is a part, contributes the least.
To be sure, drug quality is a serious problem in India, which is also a drug-manufacturing country of global heft. But, going by official data, it wouldn’t seem to be as big a problem as WHO reports. Of the samples that the Central Drug Standard Control Organisation (CDSCO) tested, 4.82% failed on quality parameters in 2011-12 and 5.1% in 2014-15. Most of the drugs that failed quality tests were substandard while fake drugs, in comparison, formed a very small pool.
It is difficult to say if the samples CDSCO collects for testing are an exhaustive representation of drugs marketed in the country—if it isn’t, then, chances are, a larger proportion of drugs are likely to be substandard or fake. Drug quality in India suffers from policy gaps as well as sputtering implementation of existing checks. One of the gaps, as safe-drugs activist Dinesh Thakur points out, relates to the very standards that India measures its drugs against. While the US drug-quality law talks of the need to hold drug quality, including the various elements of manufacture, against “current good manufacturing practice”, Indian drug testing relies on the Indian Pharmacopoeia, that was last upgraded in 2014. No wonder, Indian drugs often fail quality tests in developed markets.