Fact-check
Is modafinil legal in India?
Last checked 10 October 2026
Modafinil is a Schedule H prescription drug in India, not a supplement, and nootropics with no drug approval are not permitted as supplements under regulation 3(4) of FSSAI's 2022 regulations.
- Classification
- Restricted (Food Safety and Standards Act, 2006)
- Decided by
- Drugs and Cosmetics Rules (Schedule H); FSSAI (regulation 3(4))
- Reference
- Drugs and Cosmetics Rules, Schedule H; FSS supplement regulations 2022, regulation 3(4)
- Latest action
- 30 March 2022
- 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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Modafinil
- Schedule H prescription drug
- As a supplement
- Not permitted: a health supplement shall not include a drug (regulation 3(4))
- Nootropics generally
- Those with no drug approval are not permitted as supplements
Where the claim comes from
Searches ask whether modafinil is banned and whether nootropics are legal. The answer depends on whether the product is a drug.
Modafinil is not banned in India, but it is not a supplement either. It is a Schedule H prescription drug. That means it is for sale only against a doctor's prescription.
The 'nootropic' label does not change that. 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)). Nootropics that have no drug approval are therefore not permitted as supplements. A product sold as a nootropic supplement is lawful only if its ingredients are in FSSAI's permitted schedules.
This page does not address importing modafinil. 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
Prescription only
Modafinil is a Schedule H drug. It is for sale against a doctor's prescription, not as a supplement.
'Nootropic' is not a category in the schedules
A product sold as a nootropic is lawful as a supplement only if its ingredients are in FSSAI's permitted schedules. A drug cannot be sold as a supplement.
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 modafinil banned in India?
No, it is not banned, but it is a Schedule H prescription drug and cannot be sold as a supplement.
Are nootropics legal in India?
Only if they are lawful supplement ingredients in FSSAI's schedules. Nootropics with no drug approval are not permitted as supplements under regulation 3(4).