Who licenses what
Ayurvedic, siddha and unani (ASU) medicines are made under licences from State Licensing Authorities. The actions on record show how that works in practice. The Uttarakhand State Licensing Authority (Ayurveda and Unani) suspended the manufacturing licences of 14 products on 15 Apr 2024 under Rule 159(1) of the Drugs and Cosmetics Rules. Maharashtra FDA cancelled the licence of Inducare Pharma on 8 Aug 2026. Kerala's Deputy Drugs Controller (Ayurveda) banned the sale of six batches in Kerala in Jul 2026.
Homoeopathic medicines are drugs under the Drugs and Cosmetics Act. The Drugs Controller General of India can issue circulars to state drug controllers, as it did on 6 Jul 2026 for combinations containing phenolphthalein, which it said do not meet the definition of a homoeopathic medicine in Rule 2(dd). CDSCO's Ayush division page mostly carries lists of WHO-GMP certificates.
State labs and failed tests
State regulators draw samples from the market and test them in state laboratories. Maharashtra FDA publishes the failures in a table. As read on 9 Oct 2026 it had 190 rows, about 20 of them for ASU products. The reasons in the ayurvedic rows include fungus, microbial limit and description.
This site uses "not of standard quality" (NSQ) for a product that failed a government lab test, and "spurious" for a product found to contain a hidden drug or to be fake. Two points matter when reading either:
- A failed test is a finding on a tested sample. It is not a finding about every batch or every product of the brand.
- A failed test gives the state grounds to act on a licence. It does not ban the product by itself.
Some rows in the Maharashtra table are products sold as ayurvedic that contained drugs such as paracetamol, diclofenac, metformin or famotidine. Where the table prints the maker as unlabelled or purported, the product cannot be attributed to any licensed company.
Schedule T: good manufacturing practice
Schedule T sets the good manufacturing practice (GMP) requirements for ASU medicines. In 2026 Maharashtra FDA inspected 434 ayurvedic units, issued 135 show-cause notices and permanently cancelled 10 licences for Schedule T failures. A show-cause notice asks a firm to explain; it is not a finding.
Schedule E1 and Rule 161
Schedule E1 lists poisonous substances of the ASU systems. Rule 161 requires medicines containing them to be labelled "to be taken under medical supervision". It is a labelling rule, not a ban. The records on Schedule E1 and on heavy metals explain how it relates to the foreign alerts.
Advertising: the DMR Act, Rule 159(1) and Rule 170
The Drugs and Magic Remedies (Objectionable Advertisements) Act 1954 bars advertisements of drugs for procuring miscarriage or preventing conception, for improving sexual pleasure, for correcting menstrual disorder and for the 54 diseases in its Schedule, such as diabetes and cancer. Penalties under section 7 are up to six months for a first conviction and up to one year after that. A DMR Act seizure concerns advertising claims, not a lab test.
Rule 159(1) was the ground for the 2024 Uttarakhand suspensions, which were for repeated misleading advertising. Rule 170, which required state pre-approval of ASU advertisements, was omitted on 1 Jul 2024. The Supreme Court stayed the omission on 27 Aug 2024 and vacated the stay on 11 Aug 2025.
The Ayush Suraksha portal
The Ayush Suraksha portal (PvPI-ASU&H), launched on 30 May 2025, takes reports of adverse drug reactions and misleading advertisements. Complaints are forwarded to State Licensing Authorities. The Press Information Bureau reported on 2 Dec 2025 that 35 misleading advertisements had been reported by the public and 181 complaints resolved. The portal publishes no list of advertisements, products or actions.
Reading a notice
- Suspended or cancelled: a licence action against a firm or product.
- Banned: a sale or manufacture order, which may cover one state or named batches only.
- Seized: stock was taken, often under the DMR Act. It is not a ban.
- NSQ: a sample failed a government lab test.
- Foreign alert: a measure by another country's regulator, such as a US FDA import alert. It is not an Indian action.
The dated list of every action is on the notices page, and the failed-test records are linked from each notice.