18
Sep
Several major Indian drug firms have been caught selling inferior and potentially dangerous medicines. Most of these bad drugs have been sold in low-income countries with lax regulatory oversight.
But, up until recently, it was unclear if these reprehensible practices were confined to a few bad actors or shared widely throughout the entire Indian drug industry.
There’s now increasing evidence of the latter. A working paper we’ve just published through the U.S. National Bureau of Economic Research details the results of an extensive investigation into Indian pharmaceutical quality. We examined nearly 1,500 India-made drug samples collected from 22 cities throughout Africa.
We found that fully 10 percent of the antibiotic and anti-tuberculosis samples contained insufficient levels of the key active ingredients.
Most of those drugs aren’t counterfeit they are legally made by the legitimate companies. They contain some therapeutic elements, but probably not enough active ingredients to actually treat disease.
That means patients at the end of the supply chain are wasting their money. The pills they purchase won’t make them better.
Worse still, low-quality pharmaceuticals can fuel the creation of drug-resistant disease. When a strain of tuberculosis, for instance, is exposed to levels of a medicine that aren’t strong enough to kill, the strain can be stimulated to evolve and grown immune to future treatment.
Drug-resistant disease is already a massive problem in Africa. These low-quality Indian drugs are making it worse.
This new research complements the growing body of anecdotes indicating that India’s generic drug industry routinely violates basic quality control standards and knowingly ships sub-par medicines to foreign patients.
International regulators found over 1,600 errors in 15 drug applications submitted by the Indian generic giant Ranbaxy. Officials noted that these pills were “potentially unsafe and illegal to sell.” And as a former Ranbaxy vice president damningly put it, the company had “used the fraud as a competitive advantage to build and grow.”
Ranbaxy eventually pled guilty to seven felonies in a US court in May 2013 and paid out over half a billion dollars in fines and settlements.
And that’s not the end of the company’s violations. Back in 2012, Ranbaxy was forced to recall millions worth of drugs after investigators found glass particles mixed in with the raw ingredients used for its generic version of Lipitor. Safety officials investigated several of the firm’s Indian production facilities and found widespread failure to follow basic safety protocols and reporting requirements.
Dr. Reddy’s Laboratories, another major Indian generic manufacturer, has been forced to recall about 58,000 bottles of an ulcer medication because some of the pills were found to be contaminated.
And just this year, Dr. Reddy’s initiated another major recall, withdrawing over 13,500 bottles of a blood pressure medicine because the pills weren’t properly dissolving. Just a few weeks before that, Wockhardt Ltd., another Indian generic maker, recalled nearly 110,000 bottles of the exact same drug for the exact same reason.
Some national lawmakers have caught onto the public health risks posed by Indian drugs. Nigeria and Ghana have already outright banned pharmaceutical imports from several Indian companies. And American regulators just blocked Wockhardt from shipping in any drugs sourced from two plants that have proven particularly problematic.
But the real solution to this drug quality problem must come from within India itself. And reform starts at the top. Prime Minister Modi must make it a national priority to crack down on poor drug manufacturing practices and ensure that medicines coming out of India cease threatening public health.
If this problem isn’t forcefully addressed now, it’s bound to metastasize. India already accounts for 22 percent of the global generic drug trade and its share is growing rapidly. We already know that India makes the cheapest drugs in the world, putting in the proper quality control measures now will prevent unnecessary suffering and death.
Source: http://www.forbes.com/sites/theapothecary/2014/09/17/india-must-fix-its-drug-quality-problem/