Not surprisingly, given its earlier studies, the latest study by the health ministry has found—according to a news report in The Economic Times—that just around 3.5% of the medicines produced in the country are sub-standard; indeed, this number is lower than that in the past. While that is good news, if correct, it flies in the face of most other studies that suggest anywhere between a third and a fourth of drugs fall in this category. Indeed, if the health ministry study is correct, it doesn’t quite sit right with the penal action being taken by the US FDA against a number of Indian producers—more so, since the FDA action is being taken for medicines being produced in FDA-approved facilities which are generally acknowledged to be superior to the facilities used for producing drugs locally. One reason, as Ranbaxy whistleblower Dinesh Thakur points out, is that Indian regulations tend to focus on spurious (someone producing a drug and claiming it is produced by Pfizer, for instance) drugs while the real issue is whether it is sub-standard. Also, as Thakur points out, the US approach is that if a facility doesn’t follow good manufacturing practices, all the drugs produced by it are considered sub-standard—the Indian standards, however, focus on testing only the end-product.
Even that standard, as several studies have shown, delivers results that suggest the health ministry’s latest report is also misleading as an IndiaSpend report pointed out earlier this year. IndiaSpend cited a study by the Journal of Applied Pharmaceutical Science in December that showed that of the 32 samples of diclofenac sodium tested, the Central Drug Standard Control Organisation (CDSCO) found only five were sub-standard while the Journal found 11 were sub-standard. Similarly, a 2016 study in the International Journal of Pharmacy and Pharmaceutical Sciences for amoxicillin trihydrate shows that of the 46 samples, 28% were substandard as against 13% estimate of the CDSCO.
Instead of focusing on testing of just the end-product, CDSCO would do well to follow the US FDA practice of inspecting facilities and declaring drugs standard or sub-standard based on this—in the absence of this, the sampling methodology used is critical and can throw up all manner of results. Even more worrying is the huge shortage in drug inspectors that India has. Since the Mashelkar Committee had recommended India have one drugs inspector for every 50 manufacturing unit and one per 200 chemists, this would mean we need around 3,200 drug inspectors—the actual strength, however, is around 846 against a sanctioned strength of 1,349; the absence of adequate laboratory infrastructure is another major handicap. If the health ministry wants its study to be taken seriously, for starters, it would be nice to know just how many manufacturing facilities its inspectors have inspected in the last few years and the number of days spent on each.