Hi @Andrzej
You probably know better than I do, but I think there is some caution required in comment on “if it’s imported then the FDA has approved it.”
So the question to AI was - Do all Indian manufacturers of IVM that export to the US operate under FDA oversight. And do Indian manufacturers of IVM export to the US that do not operate under FDA oversight."
To me, there is always a ‘buyer beware’, wherever it’s purchased from. The asnwer from AI was as follows:
Not all Indian manufacturers of ivermectin (IVM) that export to the United States operate under direct FDA oversight, although any company whose ivermectin product is legally marketed in the U.S. must—by law—comply with FDA regulatory standards.
Ivermectin Exports Under FDA Oversight
Several major Indian pharmaceutical companies, such as Dr. Reddy’s Laboratories, Zydus Lifesciences, and Sun Pharma, have received formal FDA approvals for human-use ivermectin formulations like tablets or topical creams.
* Dr. Reddy’s began U.S. distribution of FDA-approved **Ivermectin Tablets USP, 3 mg**, in November 2024, confirming therapeutic equivalence to Merck’s Stromectol®.
* Zydus Lifesciences similarly received **final approval** from the FDA in 2022 for **Ivermectin Cream (1%)**, used for rosacea treatment.
These companies operate facilities inspected by the FDA under U.S. current good manufacturing practices (cGMP) and within FDA’s formal regulatory jurisdiction for approved human drugs.
Ivermectin Exports Outside FDA Oversight
However, there are Indian exporters that ship non–FDA-approved ivermectin products into the U.S. outside of authorized drug channels.
* The FDA has issued **warning letters** against websites and overseas manufacturers selling unapproved ivermectin formulations, including “Iverheal-12” tablets made by **Healing Pharma** of Mumbai, India, which are **not approved for U.S. use**.
* Such products bypass FDA application and inspection processes and enter through **internet sales or unauthorized distributors**, meaning they are **not subject to FDA quality control or oversight**.
* The FDA and U.S. Customs have also warned importers against shipments of **animal ivermectin** or human formulations shipped without approval, as part of enforcement against unregulated ivermectin imports.
FDA Oversight Limitations
Even among FDA-registered exporters, on-site inspection coverage is incomplete. As of FY2024, the FDA inspected only about 33% of Indian pharmaceutical facilities listed as suppliers for the U.S. market. This limited regulatory presence means that not every facility producing IVM intended for the U.S. is regularly monitored despite formal listing.
Investigations into companies like Glenmark and Sun Pharma have revealed FDA-documented violations and lapses in quality control even at registered exporters.
Conclusion
* **Legally imported ivermectin** from India (e.g., from Zydus, Dr. Reddy’s) is entirely under FDA oversight.
* **Other Indian firms** export unapproved ivermectin products to the U.S. (often online), and these are **not** FDA-approved or inspected.
Thus, not all Indian ivermectin exporters operate under FDA oversight, and some export unapproved formulations that circumvent U.S. drug safety controls.
So there are a few outstanding questions, and I’m happy to be corrected. Everyone please do the due diligence, to be confident with your order, wherever you’re ordering from.
And really, why would India risk its reputation or damage such a huge share of the global market?
