The grounds on which a whistleblower is taking the Indian drug regulator to the Supreme Court should make it clear that India drew no lessons from the 2013 experience, when he exposed safety and quality lapses at Ranbaxy facilities. The petitioner, Dinesh Thakur, claims that the government’s responses to over 100 RTI queries he raised show that potentially harmful medicines are being sold without the proper approvals, thanks to lax regulation—the suit names the Union health ministry, the Drugs Consultative Committee and the Central Drugs Standard Control Organization (CDSCO) as respondents. Cases of non-standard drugs, a Reuters report quotes Thakur as saying, are treated as criminal offences, and more often than not, attract only minor administrative penalties.
With India set to contribute—along with China, Brazil and Indonesia—over half of the increase in medicine usage in the next four years, lax regulation increases the likelihood of patients consuming potentially harmful drugs, more so with the government planning increased coverage of subsidised medicines. Apart from the grave outlook it has for patients’ health, it imposes a sizeable economic burden too, given, in India, nearly 60% of the spending on health is met out-of-pocket and medicines constitute 70-80% of the overall expenditure. However, Indian pharma, already plagued by allegations of rampant IPR abuse, could end up a big loser in the matter given it can ill-afford a hit to its credibility. While CDSCO estimates the proportion of sub-standard drugs in the country to be 4.5%, at least two studies, published in international journals, suggest the actual proportion could be much higher.