BAD MEDICINE
(By Roger Bate) Each time we take medicine, we assume that the manufacturer did its best to produce a quality product. Evidence is mounting, however, that some pharmaceutical manufacturers in countries like India cut corners and send low-quality products to major, developed markets. Worse still, they may have separate production lines for drugs they sell in developing markets like Africa, where poor quality is more likely to go unnoticed.
In mid-2013, India's largest drugmaker, Ranbaxy, pleaded guilty in a U.S. court to several criminal offenses relating to the fraudulent manufacture and sale of adulterated drugs. (The United States is the biggest importer of generic Indian drugs.) Among other revelations, Ranbaxy's executives acknowledged that "more than 200 products in more than 40 countries" are affected by "elements of data that were fabricated to support [Ranbaxy's] business needs." In other words, Ranbaxy made up facts and figures to demonstrate product safety for myriad drugs, including critical HIV medicines paid for by U.S. tax dollars and destined for the poor in Africa. As a consequence, the company was fined $500 million.
The Indian government, protective of its country's $20 billion pharmaceutical industry, quickly responded by claiming that Indian drugs are in fact safe. But in September, the U.S. Food and Drug Administration banned imports of drugs from another Ranbaxy plant that had not been implicated in the recent settlement.
Frighteningly, the problems with Ranbaxy are not isolated incidents. Over the past six years, my research group has sampled thousands of medicines used to treat tuberculosis, malaria, and major bacterial infections in emerging markets. Of these medicines, 3,695 were allegedly made by Indian companies. We tested them for quality and published the results in peer-reviewed publications. In short, the results were not good.
Pulling all the data together, I wanted to see whether the problems occurring at Ranbaxy were repeated by other Indian producers. After removing falsified samples, which were obviously counterfeited (they had no active ingredients, and the packaging was flawed), just over 5 percent of products failed quality-control tests. There is no evidence to suggest these samples were not made in India by the supposedly reputable firms identified on the labels. (More detailed data analysis can be found here.)
To put this finding in human terms: Given that probably over 100 million people around the world take Indian drugs every week, if one in 20 of those drugs doesn't work, millions of patients are not taking the medicines they need.
This is a shocking thought -- but in many ways, it shouldn't surprise. There is a long-standing concern that the Indian drug regulator, the Central Drugs Standard Control Organization (CDSCO), cannot be fully trusted to ensure that drugs coming out of India meet internationally agreed-upon quality standards. The CDSCO has received repeated criticism in recent years from the Indian Parliament for colluding with local companies and not testing approved products. This May, the Indian Parliamentary Standing Committee on Health and Family Welfare published a report acknowledging that at least 7 percent of medicines in India are substandard and that some "can harm patients."
This article was first published on Foreign Policy News on 4th October. This is just a magnet part of the article, if you want to read the full article, you must have to visit their website here.
No comments:
Post a Comment