Great India Overseas Pvt. Ltd. dba Silkrute

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Based on a review of your website, “ProGlan Capsules,” “Cordiagra,” and “Prost Aid Tablet” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body.

Passage 2

“ProGlan Capsules,” “Cordiagra,” and “Prost Aid Tablet” are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p), because they are not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in their labeling.

Passage 3

No approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these products. Accordingly, these products are unapproved new drugs.

Passage 4

“ProGlan Capsules” is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because the product label and/or website include a statement that misleadingly suggests that the drug product is approved or endorsed by FDA in some way.