No Indian rule we could find is written for shilajit alone. A shilajit product is regulated by the route its maker chooses: as a food such as a health supplement or nutraceutical, licensed under FSSAI, or as an Ayurvedic medicine, made under a drug licence issued by a state licensing authority under the Drugs and Cosmetics Act. The label tells you which. Neither licence tells you whether shilajit suits you, so if you are pregnant, take medicine or have a health condition, follow your doctor's advice first.
This guide works from official documents we opened: FSSAI's nutraceutical and labelling regulations, and the Drugs and Cosmetics Act and Rules. It says nothing about any brand.
At a glance
- FSSAI's 2022 nutraceutical regulations exclude anything that is a drug under the Drugs and Cosmetics Act, so one product cannot sit in both routes.
- The regulation text and schedules FSSAI issued in October 2022 do not name shilajit; an unlisted ingredient needs FSSAI's prior approval.
- FSSAI's Labelling and Display Regulations 2020 require the FSSAI logo and licence number on a food pack, plus a batch number and dates.
- Rule 161 of the Drugs and Cosmetics Rules requires an Ayurvedic drug label to show "Ayurvedic medicine" and its manufacturing licence number.
- Under Rule 152 of the Drugs and Cosmetics Rules, Ayurvedic drug manufacturing licences come from licensing authorities appointed by each state government.
How is shilajit regulated in India?
Through one of two laws, depending on how the product is made and presented. As a food, it falls under the Food Safety and Standards Act and FSSAI's nutraceutical rules. As an Ayurvedic medicine, it falls under the Drugs and Cosmetics Act of 1940. We found no rule written for shilajit by name in either.
Shilajit is an established Ayurvedic ingredient. A 2011 review counted it in twenty classical (Sastric) formulations and twenty-four proprietary drugs (Wilson and colleagues, 2011).
The two do not overlap. FSSAI's 2022 nutraceutical regulations say the products they cover "shall not include a drug as defined in clauses (a), (b) and (h) of section 3 of the Drugs and Cosmetics Act". Clause (a) is the Ayurvedic drug, and clause (h) is the patent or proprietary medicine.
What makes shilajit an Ayurvedic drug under the law?
Its intended use and its formula. The Act defines an Ayurvedic drug as a medicine meant for the diagnosis, treatment, mitigation or prevention of disease or disorder, made exclusively to formulae in the authoritative Ayurvedic books listed in its First Schedule. A product built from those ingredients to a new formula is a patent or proprietary medicine.
The First Schedule is a list of classical texts, including the Charaka Samhita, Sushruta Samhita, Ashtanga Hridaya and Bhaishajya Ratnavali. Section 3(h) defines a patent or proprietary Ayurvedic medicine as a formulation containing only ingredients mentioned in the formulae of those books, but not itself a formulation included in them.
Section 33EEC bars the manufacture of an Ayurvedic drug for sale except under a licence, and section 33EEB requires manufacture to the standards prescribed for that drug, if any. Rule 152 says each state government appoints the licensing authorities, and Rule 153 sets out the application for a manufacturing licence.
We could not open an official copy of the Ayurvedic Pharmacopoeia of India, so this article does not describe what it says about shilajit (shilajatu), or whether it sets a standard for it.
Can shilajit be sold as an FSSAI health supplement?
It can be sold in that category only on FSSAI's terms. The 2022 regulations allow ingredients listed in their schedules, and the version FSSAI issued with its October 2022 direction does not name shilajit. An unlisted ingredient needs FSSAI's prior approval, on a history of safe use or under its rules for non-specified foods.
The schedules cover nutrients, more than four hundred plants and botanicals, other extracts and isolates, and prebiotics and probiotics. Schedule III includes non-plant items such as selenium yeast and shark cartilage, but we found no entry for shilajit, mumijo, asphaltum or mineral pitch in any of them.
For ingredients the regulations do not provide for, there are two routes:
- History of safe use. Ingredients with a documented, incident-free history of safe use of at least thirty years in their country of origin, or fifteen years in India, may be allowed with FSSAI's prior approval.
- Non-specified food approval. Any other new ingredient needs approval under the Food Safety and Standards (Approval of Non-Specified Food and Food Ingredients) Regulations, 2017.
We found no FSSAI approval for shilajit in the documents we opened, and cannot say whether one exists. FSSAI's direction also notes that the 2022 regulations were still awaiting final notification and were operational by direction from 1 October 2022, so check FSSAI's site for later changes.
Where FSSAI has not set purity criteria for an ingredient, a maker may adopt those of recognised pharmacopoeias, including the Ayurvedic Pharmacopoeia of India. Products for children aged two to five may be given only on the advice of a doctor, dietician or nutritionist.
What must a shilajit label show on each route?
On the food route, the FSSAI logo and licence number, the word "HEALTH SUPPLEMENT" or "NUTRACEUTICAL" on the front, and "NOT FOR MEDICINAL USE". On the drug route, the words "Ayurvedic medicine", a manufacturing licence number, a full ingredient list with quantities, and an expiry date where the rules set a shelf life. Both need a batch number and a date of manufacture or packing.
| Route | Regulator | What the label must show | Source |
|---|---|---|---|
| Health supplement or nutraceutical (food) | FSSAI, under the Food Safety and Standards Act, 2006 | FSSAI logo and licence number; "HEALTH SUPPLEMENT" or "NUTRACEUTICAL" near the product name; "NOT FOR MEDICINAL USE"; recommended usage level; "Not to exceed the recommended daily usage"; known side effects and interactions where applicable; batch number; date of manufacture or packing; expiry or use-by date | FSSAI nutraceutical regulations 2022, reg. 5(12); Labelling and Display Regulations 2020, reg. 5(7), 5(9), 5(10) |
| Classical Ayurvedic medicine (made to a formula in a First Schedule book) | State-appointed licensing authority, under the Drugs and Cosmetics Act, 1940 | Name as given in the authoritative book; "Ayurvedic medicine"; ingredients with quantities and a reference to the text; maker's name and address; "Mfg. Lic. No." or "M.L." with the number; batch number; date of manufacture; expiry date, except for medicine groups Rule 161B lists with no expiry | Drugs and Cosmetics Act s. 3(a); Rules 152, 161 and 161B |
| Patent or proprietary Ayurvedic medicine (new formula from classical ingredients) | State-appointed licensing authority, under the Drugs and Cosmetics Act, 1940 | Same particulars, with a true list of all ingredients and their quantities | Drugs and Cosmetics Act s. 3(h); Rule 161 |
FSSAI's labelling rules say the brand owner's FSSAI logo and licence number must appear, plus the manufacturer's or packer's licence number if different. On the drug side, Rule 161 adds that a medicine for internal use made from a substance in Schedule E(1) must carry "Caution: To be taken under medical supervision" in English and Hindi.
Our guide to how to identify pure shilajit covers the checks you can make at home.
How can you check a shilajit label before you buy?
Work out which route the product claims, then check the label against it. A food pack should have an FSSAI licence number you can look up; a medicine should say "Ayurvedic medicine" and carry a manufacturing licence number. A pack making claims its route forbids deserves questions.
- Find the route. Look for "HEALTH SUPPLEMENT" or "NUTRACEUTICAL" with "NOT FOR MEDICINAL USE", or for "Ayurvedic medicine" with "Mfg. Lic. No.".
- Look up an FSSAI number. FSSAI's FoSCoS portal has an FBO Search that takes a licence or registration number or a company name. Finding the business there still tells you nothing about what is in the jar.
- Check the claims against the route. FSSAI's 2022 rules say supplements must not claim to treat, cure, mitigate or prevent any specific disease, disorder or condition unless the Food Authority specifically permits it. "NOT FOR MEDICINAL USE" beside a cure claim is a contradiction.
- Read the ingredient list. A drug label must list every ingredient with its quantity. A supplement must declare, on the pack or a leaflet, the amount of the substances with a nutritional or physiological effect.
- Match the batch and dates. Both routes require a batch number and a date of manufacture or packing. Use the batch number to ask for that batch's test report.
What does a licence not tell you?
It does not tell you whether a product is safe for you, or what a particular batch contains. A licence shows which law a maker works under. A 2024 review of published analyses found reported heavy-metal levels in shilajit mostly below WHO and FDA limits, "except in few studies where exceeded levels were reported" (Hussain and Saeed, 2024). So the batch test matters more than the licence, and your doctor's advice matters more than either.
Neither label list in the table includes a heavy-metal result. Our article on shilajit heavy-metal testing explains what a report should cover. The shilajit safety guide covers the reported side effects and who should ask a doctor first.
The 2011 review also concluded that the bioactivity of shilajit "lacks substantial evidence". A licence on either route is not evidence that the product works.
The short version
India regulates shilajit by route, not by name. Sold as a food, it falls under FSSAI, whose 2022 nutraceutical rules do not list shilajit and require approval for unlisted ingredients; the pack must show the FSSAI logo and licence number and "NOT FOR MEDICINAL USE". Sold as an Ayurvedic medicine, it is made under a licence from a state-appointed licensing authority, and the label must say "Ayurvedic medicine" and give the manufacturing licence number. Neither licence proves purity or suitability, so ask for a batch report and follow your doctor's advice.
Sources
Further reading behind the figures above. Himdhara's own numbers — yields, batch results — come from our production records and the batch reports on the lab reports page.
- Food Safety and Standards Authority of India (2022). Direction regarding operationalisation of FSS (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose and Prebiotic and Probiotic Food) Regulations, 2022. FSSAI.
- Food Safety and Standards Authority of India (2025). Food Safety and Standards (Labelling and Display) Regulations, 2020, Version VIII. FSSAI.
- Ministry of Health and Family Welfare (2016). The Drugs and Cosmetics Act and Rules (as amended up to 31 December 2016). CDSCO.
- Wilson E, Rajamanickam GV, Dubey GP, et al. (2011). Review on shilajit used in traditional Indian medicine. Journal of Ethnopharmacology.