Fact-check
Is sibutramine banned in India, and can it be in weight-loss supplements?
Last checked 10 October 2026
Sibutramine has been a banned drug in India since 2011 under Section 26A of the Drugs and Cosmetics Act, so it cannot lawfully be in any weight-loss supplement; supplements found with it are a US FDA import alert matter, alert 54-16, which lists Indian firms.
- Classification
- Prohibited (Food Safety and Standards Act, 2006)
- Decided by
- Central Government under Section 26A of the Drugs and Cosmetics Act
- Reference
- Section 26A, Drugs and Cosmetics Act, 2011; US FDA import alert 54-16 (foods and supplements containing undeclared drug ingredients)
- Latest action
- 30 March 2022
- Last checked
- 10 October 2026
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FSSAI direction operationalising the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations 2022
Scope. A record here does not by itself mean a product or company is unsafe or banned today. Regulatory actions can apply to one batch, one formulation, one period or one state. Always check the linked government document for the current position, and tell us if something is out of date. How we label records.
Below: Blacklisted's explanationWe organise and explain what the document says. The document above is the authority.
Key facts
- India
- Banned as a drug under Section 26A since 2011
- In supplements
- A health supplement may not include a drug (regulation 3(4)), so sibutramine cannot lawfully be an ingredient
- Abroad
- Weight-loss supplements found with sibutramine are a US FDA import alert matter: alert 54-16, foods and supplements containing undeclared drug ingredients, lists Indian firms
- Banned drugs list
- This site's list is at /medicines/banned
Where the claim comes from
Sibutramine appears in warnings about weight-loss products sold as supplements abroad. In India the drug itself has been banned since 2011.
Sibutramine is a banned drug in India. It has been banned since 2011 under Section 26A of the Drugs and Cosmetics Act. Our list of banned drugs, at /medicines/banned, carries it. There is no separate sibutramine page on this site.
That settles its place in supplements. FSSAI's health supplement regulations of 2022 say a health supplement shall not include a drug as defined in the Drugs and Cosmetics Act (regulation 3(4)). A banned drug is a drug. A weight-loss supplement that contains sibutramine is therefore not a lawful supplement, whatever the label says.
The concern is real abroad. Weight-loss supplements found with sibutramine are handled under US FDA import alert 54-16, which covers foods and supplements containing undeclared drug ingredients. The alert's country page for India lists Indian firms, along with alert 54-14 on supplement manufacturing practice. This page names no firm and makes no claim about any product.
What this means for you
A weight-loss supplement with sibutramine is not a lawful supplement
Sibutramine is a banned drug. It cannot lawfully be in a pack sold as a supplement.
It may not be on the label
The US alert concerns undeclared drug ingredients. A label that does not list sibutramine does not prove it is absent, but this page makes no claim about any named product.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Is sibutramine banned in India?
Yes. It has been a banned drug since 2011 under Section 26A of the Drugs and Cosmetics Act. See the banned drugs list at /medicines/banned.
Which Indian supplements contain sibutramine?
This page names none. The US FDA's import alert 54-16 covers foods and supplements with undeclared drug ingredients and lists Indian firms.
Official sources and primary records
- FSSAI direction operationalising the FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, and Prebiotic and Probiotic Food) Regulations 2022RegulatorFSSAI · 30 March 2022
- US FDA import alerts: firms from India (including alerts 54-16 and 54-14)RegulatorUS Food and Drug Administration