FDA Prohibitions on Certain Indian Pharmaceutical Firms Raises Worries over Generic Drugs on US Markets
The US Food and Drug Administration (FDA) is passing stricter regulations on drug companies serving American markets with generic drugs. Certain Indian companies will be affected. On the 1st of April in 2014, the FDA passed the new restrictions on certain drug imports, specifically those related to major Canadian firm, Apotex. This firm’s Indian manufacturing wing infringed certain FDA guidelines. Apotex is not the first multinational pharma co. to fall under the hammer, other firms which have suffered a similar crackdown just in the last year include Sun Pharmaceutical, Ranbaxy, Wockhardt and others.
The FDA restrictions have caused a degree of worry over the safety of other Indian generic drugs distributed within the US. We consulted with industry experts and the FDA itself to determine whether the many Indian generic medications which remain on the US market are reliably safe.
There are More FDA Sanctions Against Indian Manufacturers than Ever Before - Why?
The primary reason is that both Indian and American inspections have become stricter, in a concerted effort to ensure Indian drug manufacturers are meeting the safety standards and regulations demanded by the FDA. As ever more companies, such as those mentioned above like Apotex or Sun Pharma, are manufacturing offshore to lower costs, such inspections are receiving increased focus and have been ramped up accordingly. The US Congress passed the FDA Safety and Innovation Act in 2012 which governs, inter alia, agency inspections of overseas drug manufacturers which supply the US market. The Act demands that such overseas plants be inspected and regulated as strictly as local plants. In the preceding year, the government of India allowed the addition of 7 more FDA drug inspectors, for a grand total of 19 American agents within India.
An FDA spokesman confirmed via email that his agency has increased its offshore efforts, India included. He commented that the majority of Indian manufacturers meet industry standards for best practice and that problems are isolated to a handful of companies. Quality remains the agency’s focus, with only a small percentage of Indian-made drugs falling afoul of FDA restrictions.
Are such Quality Control Issues Exclusive to India?
Absolutely not. The FDA spokesman stated the problems discovered by inspectors within India were also to be found in plants the world over. An example was cited of a problem encountered the previous year, whereby the FDA issued a series of warning concerning issues in packaging or manufacturing. Such infraction warnings were sent not only to Indian firms, but to firms in Spain, Ireland, Japan, Germany, China, Canada, Austria and Australia. The most frequently-encountered issues included contamination of products, errors in data reporting and failure to meet quality and testing standards.
Two issues of particular concern were medical devices and pharmaceuticals from China, the import of which increased by a factor of almost five between the years 2013 from 2007. The FDA was under great pressure to scale to meet the expansion of Chinese imports. The FDA’s import alerts for that period show that the agency restricted as many Chinese as Indian firms over this period. Such import alerts may sanction the import of affected goods, banning them from the US entirely until the firm meets the agencies requirements. Similar to the Indian situation, the FDA is working alongside the Chinese state and their manufacturers to expand efforts in the region. FDA staff in China will be increased from 8 to 27 personnel so as to better monitor and control the quality of such products in future.
Are Brand Name Drugs More Reliable than Generics?
Unfortunately not. Standards for manufacturers are equivalent for generic and branded drugs. Often times, branded drugs are produced overseas, frequently by the same firms which produce the generic versions thereof.
Problems with manfacutring have also been known to occur in American plants. As an example, the largest drug recall in American history (as reported by QuarterWatch) resulted from an American manufacturer’s error. QuarterWatch is a publication dedicated to drug safety and is published by the not-for-profit Institute for Safe Medication Practices. The publication reported millions of over-the-counter drugs were recalled, including such popular brands as Motrin and Tylenol, causing a huge volume of medication to be removed from pharmacies. The purge ran from September 2009 and affected products produced by Johnson & Johnson’s subsidiary, McNeil Consumer Healthcare. This firm has its HQ in Fort Washington, Pennsylvania. Manufacturing plants in both Puerto Rico and Pennsylvania were responsible.
More than two thousand reports of bad effects on patient related to the manufacturing problems were submitted to the FDA.
Should you Use American-Made Drugs Exclusively?
You can but it will likely prove impractical. Roughly forty percent of the drugs American use on a daily basis are produced overseas. Two of the world largest pharmaceutical conglomerates facilities are in China and India respectively, with as many as 500 FDA-registered manufacturing facilities between them.
When taking into account that eighty percent of drug components used in pharmaceutical manufacture are derived from foreign shores, it’s a complex task indeed to judge where precisely the drug stems from, whether or not such ingredients are combined within the USA.
Barbara Young, Pharm.D. and editor of the American Society of Health-System Pharmacist’s consumer information admits that it’s very difficult to determine a medication’s origin. She states that there is often no direct link back to a producer as drugs are often renamed or repackaged as they cross borders.
How is the Safety of Foreign-Made Drugs Being Guaranteed?
Not only are more stringent requirements being implemented by the FDA but the agency and its foreign counterparts are expanding their staff and resources. The FDA has also began a significant research effort which will bring in numerous academic institutions in order to ensure the quality and supply of generic pharmaceuticals for the US market.
Consumer Reports is also monitoring any and all relevant developments. Keep up to date with our coverage for further information.