If someone is buying from India, I would suggest targeting medications from only the largest of the Pharma companies (i.e. top 15 or so companies). There are many smaller pharma companies, that don’t adhere to international quality standards it seems.
Here is a list I found that may be helpful in this quest (Source here)
In this article, we will explore the Top 20 Pharmaceutical Companies in India and their contributions to the industry.
Yes - that is probably a good idea, but it takes a little more research to figure out those companies that do sell to Western Europe and USA. I’d guess that its these from the top of my head, but if anyone knows better, please post:
Also, with the exception of Intas, which is private, all the above companies are traded on the New York Stock Exchange. So they have the constant scrutiny of the markets.
Indian pharma improves compliance with USFDA; fewer OAI cases in 2024
In 2023, the USFDA conducted 225 inspections, which led to 18 cases of Official Action Indicated (OAI) and 117 cases of Voluntary Action Indicated (VAI). By 2024, despite a tightening of regulatory standards, the number of inspections dropped to 206, while OAI cases fell to 14 and VAI cases reduced to 115. This highlights that the sector is increasingly aligning with global benchmarks to ensure high-quality manufacturing practices.
Yes… but. The FDA currently has to give advanced notice of inspections to the Indian Pharma… and there have been many situations where Indian Pharma has been caught (insiders reveal) changing / modifying things to make them look better during the inspection… so I’m not super confident that things are that much better.
Avoid Glenmark medications, it seems: (Note: these are drugs that are imported into the USA through the regular supply chain channels and distributed via regular pharmacies here in the US).
In February, the FDA found problems with cleaning and testing at the plant in Madhya Pradesh, India, which was the subject of a ProPublica investigation last year. The current recalls, listed in an FDA enforcement report last week, cover a wide range of commonly prescribed medicines, including ones that treat epilepsy, diabetes, multiple sclerosis, heart disease and high blood pressure, among other ailments. A full list of the recalled medications is available here.
Records show that Glenmark first alerted wholesalers about the recalls in a March 13 letter. That letter suggests that Glenmark pulled the drugs because of potential cross-contamination. Thomas Callaghan, Glenmark’s executive director of regulatory affairs for North America, wrote that 148 batches of the recalled medicines were made “in a shared facility” with two cholesterol-lowering drugs, ezetimibe and a combination of that drug and simvastatin.