In the United States, the cost of brand-name prescription medication has been increasing, prompting consumers to switch to generic drugs – the cheaper alternatives to brand-name drugs.
Most consumers are often surprised to know about the generic drugs prescribed to them. It has been found that more than 90% of the medicines prescribed by US doctors are generics. Surprisingly, at least one-third of those generic drugs are likely to be manufactured in India.
India is called the “pharmacy of the world” because it is the largest provider of generic medicines, supplying over 18% of global generic medicines, according to Pharma Manufacturing, a company that aims to serve the informational needs of pharma and biopharma professionals.
However, there have been concerns about the safety and efficacy of imported generic medicines, with consumers raising questions about the quality of generic medicines manufactured in India.
Pharma Manufacturing says that the generic drugs made in India are as safe and effective as those made in the United States. That’s because the expectations of the global drug regulatory bodies have increased and their regulations have become stringent.
However, some experts are still concerned about the safety and efficacy of generic drugs made in India.
Investigative journalist and author Katherine Eban has warned that some of the generic drugs might not be as safe or effective as we think.
Eban’s work focused on public health and homeland security issues. She has been covering the pharma industry for over 10 years.
In 2019, Eban said that most of the generic medicines sold in the U.S. are manufactured in India and China, according to NPR.
In her book titled “Bottle of Lies,” she wrote that the FDA often “announces its overseas inspections weeks in advance, which allows plants where generic drugs are made the chance to fabricate data and results.”
“These plants know that [the FDA inspectors are] coming,” she added. “I discovered [some overseas drug companies] would actually … alter documents, shred them, invent them, in some cases even steaming them overnight to make them look old,” which is why some generic drugs enter the US market without proper inspection.
Eban called the FDA “overwhelmed and under-resourced” in its efforts to ensure the safety of generic drugs produced in India and other nations, advising American consumers to do their research before switching to any generic medicines bought overseas.
“Once you understand how vital these regulators are to safety and well-being, basically any sane American is not going to want to take a pill that’s coming from a plant that’s uninspected,” Eban explained.
How much should you worry about the safety of generic drugs made in India?
Eban said one drug investigator told her that he thinks the safety concern is higher for people on maintenance medications who have to take them on a daily basis. The takeaway is: it is unclear whether generic drugs made in India are safe or effective. However, experts advise consumers to research and check with their doctor to understand whether it is safe to switch from brand to generic drugs, especially those made in India.
