Regulatory status record
Is Gatifloxacin banned in India?
Last checked 19 September 2026
Gatifloxacin for systemic (oral and injectable) use has been banned in India since GSR 218(E) of 16 Mar 2011 because of severe blood-sugar disturbances; gatifloxacin eye and ear drops remain legal.
- Classification
- Prohibited under Section 26A, Drugs and Cosmetics Act, 1940
- Decided by
- CDSCO / Ministry of Health and Family Welfare
- Reference
- GSR 218(E), 16 Mar 2011
- Latest action
- 16 March 2011
- Last checked
- 19 September 2026
Gatifloxacin eye-drop pack. Photo: GFLX-Gatifloxacin.jpg by メルビル (CC BY-SA 4.0). Brand names and logos belong to their owners and are used here to identify the product this entry is about. All photo credits.
CDSCO: Drugs banned in India (consumer section)
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Governing authority
- CDSCO, Ministry of Health and Family Welfare
- Notification
- GSR 218(E), 16 Mar 2011
- Reason
- Dysglycaemia, severe high and low blood sugar, especially in older and diabetic patients
- Still legal
- Gatifloxacin eye drops and ear drops
- Same period
- Tegaserod and other drugs banned in the same 2011 round
Gatifloxacin is a fluoroquinolone antibiotic that was withdrawn in most countries in the mid-2000s after reports of dangerous swings in blood sugar, both very high and very low, especially in older people and those with diabetes. India kept it on sale until 2011.
On 16 March 2011 the Health Ministry prohibited gatifloxacin formulations for systemic use under GSR 218(E), a notification issued under Section 26A of the Drugs and Cosmetics Act. The order covers tablets and injections. It does not cover topical preparations, so gatifloxacin eye drops, used after cataract surgery and for bacterial conjunctivitis, and ear drops remain legal and are widely prescribed. This split is the source of most confusion: someone who has just been given gatifloxacin eye drops finds "gatifloxacin banned in India" online and wonders whether the pharmacist has made a mistake.
No court has stayed the 2011 notification, and the drug is listed among the banned drugs in the CDSCO's consumer document. Manufacturers moved to levofloxacin and moxifloxacin, which remain available on prescription with the usual fluoroquinolone cautions about tendons and heart rhythm.
If you are prescribed gatifloxacin drops, use them as directed. If you are offered gatifloxacin tablets, they should not be on the market; ask your doctor for an alternative.
What this means for you
Eye drops are fine
Gatifloxacin ophthalmic solutions are widely used after eye surgery and for conjunctivitis and are not affected.
Tablets should not exist
If you are offered gatifloxacin tablets, they are illegal stock; other fluoroquinolones such as levofloxacin remain available on prescription.
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 gatifloxacin eye drops banned in India?
No. The 2011 ban applies to oral and injectable forms only.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Gatifloxacin Formulation for Systemic Use in Human by any Route Including Oral and Injectable | Banned | GSR 218(E) | 16 March 2011 | In force per CDSCO consumer list (1983-2017) |
Official sources and primary records
- News
- Regulator
- Regulator