It is because India’s drugs authorities have been so lax that Ranbaxy-type frauds happen, poor quality persists
Under normal circumstances, US-based investigative journalist Katherine Eban’s Bottle of Lies, primarily based on the fraud in Ranbaxy, may not have created the stir it did. After all, frightening as the faking of data at Ranbaxy was, much of this is well known; and though Wockhardt, Mylan, GVK Biosciences, Zydus, Dr Reddy’s feature in the book in varying degrees, the book is really about Ranbaxy. What makes the book’s subject more worrying is the number of US FDA actions on various Indian pharmaceuticals firms.
Just earlier this month, the FDA pointed to the destruction of quality-control paperwork and scant documentation of safety tests at the Strides Pharma’s plant in Puducherry and said that this raises questions about quality control at Strides and the “integrity and accuracy” of its data. Last month, the US regulator had warned Aurobindo Pharma for ignoring impurities in valsartan, the anti-hypertension drug it produces. The FDA has issued 209 warning letters so far, of which nine are to Indian Pharma companies, versus eight out of 419 in 2018.
It is, of course, possible to allege a bias in such reporting; Eban, after all, nudges readers to trust top brands, from patent-holders, over generics. And the well-known revolving door that allows FDA officials to move to US pharma firms does put a bit of a question mark over the findings, more so since Indian generics are making inroads into US markets. But if, after all this, people are willing to believe Eban, it is due to a colossal failure of Indian authorities to regulate; this is made worse by the desire to understate the extent of the problem. India’s drug regulator, the Central Drug Standards Control Organisation, for instance, is woefully understaffed; against a recommended 4,200 drug inspectors (based on the Mashelkar Committee formula), the total number of sanctioned posts in the states and UTs, as of April 2018, was 1,600 and just 1,200 were actually filled.
Similarly, in January 2019, there were just 224 inspectors with the CDSCO against a sanctioned 510. This is compounded by varying regulatory regimes in states; as a result, drugs declared to be sub-standard in one state may still get sold in another before the regulator of the latter catches up. India may not, unlike Ranbaxy-whistleblower Dinesh Thakur argues, have two standards for drugs manufacture—a superior one at FDA-approved labs and an inferior one for the local population, but various studies from time to time report poor quality drugs. A few years ago, the CAG reported that 15-31% of the drugs drawn from different Armed Forces Medical Stores Depots were not of standard quality. And yet, most official studies point to very low levels of spurious drugs in the country even though most in the industry cite numbers ranging from 25-40%; government controls on prices that leave wafer-thin margins are another reason for the proliferation of spurious drugs.
Rather than trying to shout down those who talk of a problem in India’s drugs production and regulatory regime, and a bias in the writings of those like Eban, India would be better served by strengthening its regulatory regime. It is a sad day when both drug manufacturers and government officials boast of how many FDA-certified production facilities India has instead of talking of how strict Indian quality control is; that is the surest proof of the fact that the Indian regulatory system is all but non-existent.