Great India Overseas Pvt. Ltd. dba Silkrute

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) review of your website. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that may exist in connection with your products or operations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

Violations were identified and documented during a review of your website https://www.silkrute.com in May 2026. Based on our review, “ProGlan Capsules,” “Cordiagra,” and “Prost Aid Tablet” are unapproved new drugs under sections 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). As explained further below, introducing or delivering these products for introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). Furthermore, “ProGlan Capsules” is a misbranded drug under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), introduced or delivered for introduction into interstate commerce in violation of section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

This review was conducted as part of FDA's public health responsibility to protect the public from unsafe, ineffective, and poor-quality drugs.

The following are violations identified during our review. As a reminder, this is not an all-inclusive list of violations that may exist in connection with your products or operations.

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. Examples from your product labeling, including on your website, that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as drugs include, but may not be limited to, the following:

On the webpage https://www.silkrute.com/health-and-personal/diet-and-nutrition/supplement/crd-ayurveda-proglan-prostate-gland-capsules-50-capsules:

“Useful in problems of Prostate Glands . . . improves immune system and improves overall muscle strength. ProGlan capsules help in maintaining urinary health. These supplements are good for keeping prostate health in check by combining the best and most natural ingredients.”

On the webpage https://www.silkrute.com/health-and-personal/diet-and-nutrition/supplement/cordy-herb-cordiagra-stamina-and-energy-booster-mens-sexual-wellness-capsule-for-erectile-dysfunction-with-cordyceps-honey-goat-weed-tongat-ali-maca-root-ginseng-ashwagandha-10capsule:

“Increase Your Sexual Drive, Strength & Stamina.”

“For Sexual Dysfunction”

“FOR ERECTILE DYSFUNCTION”

On the webpage https://www.silkrute.com/health-and-personal/diet-and-nutrition/supplement/baidyanath-prostaid-i-urinary-track-infection-i-50-tablets:

“[A]lleviates the symptoms of BPH[,] urgency of urine[,] urinary tract infection”

“Indications: Helps in problems of urination i.e., Urinary hesitancy, Dysuria (burning and painful urination)”

“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. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). 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. The introduction or delivery for introduction into interstate commerce of these unapproved new drug products violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

“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. The product labeling for “ProGlan Capsules” includes an image of the FDA logo accompanied by the claim “APPROVED.” This assertion misleadingly suggests that “ProGlan Capsules” is approved or endorsed by FDA in some way. “ProGlan Capsules” is not the subject of an FDA-approved application or is endorsed by FDA. Therefore, this product is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. 352(a), because its labeling is false or misleading. The introduction or delivery for introduction of a misbranded drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure sustained compliance so that these violations and any others do not occur.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

Please note FDA posts warning letters on www.fda.gov.