Fact-check
Is melatonin legal in India?
Last checked 10 October 2026
Melatonin is not banned in India as of 10 Oct 2026: FSSAI's schedules permit it as a nutraceutical at 2 to 10 mg a day, but some melatonin fixed-dose combinations appear on CDSCO's list of banned combinations.
- Classification
- Restricted (Food Safety and Standards Act, 2006)
- Decided by
- FSSAI (supplements); CDSCO (fixed-dose combinations)
- Reference
- FSSAI direction of 30 Mar 2022 (schedules of permitted ingredients); CDSCO list of banned fixed-dose combinations, as reported by Free Press Journal, Apr 2026
- Latest action
- 1 April 2023
- Last checked
- 10 October 2026
Photo: Free medicine thermometer image by rawpixel (cc0). All photo credits.
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Permitted dose
- 2 to 10 mg per day as a nutraceutical, per FSSAI's schedules
- Gummies
- Lawful within that range
- Combinations
- Some melatonin fixed-dose combinations (FDCs) appear on CDSCO's banned FDC list; no specific products are named on this page
- Banned drugs list
- This site's list of banned drugs is at /medicines/banned
- Label
- 'NOT FOR MEDICINAL USE' is required on products under the 2022 regulations
Where the claim comes from
The Free Press Journal reported in April 2026 that sleep gummies are growing quickly in India, and some melatonin combinations appear among the fixed-dose combinations CDSCO has banned. Searches such as 'is melatonin banned in india' can mix the two.
Melatonin is legal in India as a nutraceutical, within a limit. FSSAI's schedules, put into operation by its direction of 30 Mar 2022, permit melatonin at 2 to 10 mg per day. Gummies and tablets that stay within that range and carry the required label, 'NOT FOR MEDICINAL USE', fall within the permitted schedule.
The complication is combinations. A report in the Free Press Journal in April 2026 noted that some melatonin fixed-dose combinations were among the combinations on CDSCO's banned list. We do not name any specific combination here, because the research behind this page does not. Our own list of banned drugs is at /medicines/banned.
So the answer depends on what is in the pack. Melatonin alone, at 2 to 10 mg a day, is within FSSAI's schedule. Melatonin mixed with other active ingredients is a drug question first, and regulation 3(4) says a health supplement shall not include a drug as defined in the Drugs and Cosmetics Act. As of 10 Oct 2026 the 2022 regulations still work through FSSAI directions; no final gazette notification was found in 2025 or 2026.
What this means for you
Check the dose per serving
FSSAI's schedule permits 2 to 10 mg a day. A gummy or tablet is within the schedule only if the daily dose on the label falls in that range.
Single ingredient or combination
The ban list concerns fixed-dose combinations, not melatonin on its own. If a product pairs melatonin with other active ingredients, look it up on CDSCO's list and on our banned drugs list at /medicines/banned.
This is a record of official orders, not medical advice. Do not stop a prescribed medicine without asking your doctor or pharmacist.
Common questions
Are melatonin gummies legal in India?
Yes, within the permitted range of 2 to 10 mg a day and with the required label, 'NOT FOR MEDICINAL USE'.
Is melatonin on CDSCO's banned list?
Some melatonin fixed-dose combinations appear on CDSCO's list of banned combinations, as reported in April 2026. Melatonin as a single nutraceutical ingredient is permitted within the limit.
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
- Sleep gummies are exploding in India, but at what costNewsFree Press Journal
- FSSAI direction: re-operationalisation of the FSS (Nutraceutical) Regulations 2022 from 1 Apr 2023RegulatorFSSAI · 1 April 2023