Regulatory status record
Is pregabalin banned in India?
Last checked 3 November 2026
Pregabalin is not banned in India at 300 mg or any other strength; G.S.R. 377(E) of 13 May 2026 adds it to Schedule H1, with stricter prescription and record rules that come into force after the delay stated in the rules, and one pregabalin combination was halted in April 2025.
- Classification
- No ban or recall found in official records
- Decided by
- Ministry of Health and Family Welfare; CDSCO
- Reference
- G.S.R. 377(E), 13 May 2026, Drugs (Second Amendment) Rules, 2026 (published 20 May 2026); draft G.S.R. 54(E), 21 Jan 2026; CDSCO letter of 11 Apr 2025, Annexure Sr. 12
- Evidence
- Government document
- Latest action
- 20 May 2026
- Last checked
- 3 November 2026
Photo: Blister of tablets.jpg by unknown (CC BY-SA 4.0). All photo credits.
G.S.R. 377(E): Drugs (Second Amendment) Rules, 2026 (Gazette copy)
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 Always check the linked government document for the current position, and tell us if something is out of date.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
- Ban status
- Not banned. No order names pregabalin 300 mg or any single strength
- Schedule H1
- G.S.R. 377(E), 13 May 2026, inserts '51. Pregabalin' in Schedule H1 of the Drugs Rules, 1945; published in the Gazette on 20 May 2026
- When it applies
- The rules say they 'shall come into force after one eighty days' from publication; read as 180 days, that is in November 2026
- What Schedule H1 means
- Sale only on a prescription from a registered medical practitioner, a separate register of prescriptions and sales at the chemist, and a Schedule H1 warning on the pack
- Before the change
- Schedule H prescription drug (Deccan Herald, Indian Pharma Post)
- Halted combination
- Pregabalin SR 75 mg + nortriptyline 10 mg + vitamin D3 2000 IU + mecobalamin 1500 mcg tablet: CDSCO direction to states, 11 Apr 2025
Where the claim comes from
The May 2026 Schedule H1 notification was reported as a crackdown on pregabalin misuse, and the April 2025 halt of a pregabalin combination was listed among 'banned' drugs. Searchers read both as a ban, often naming the 300 mg strength.
Pregabalin, used for nerve pain, is not banned in India, at 300 mg or any other strength. What changed in 2026 is how tightly it is sold.
On 13 May 2026 the Health Ministry notified G.S.R. 377(E), the Drugs (Second Amendment) Rules, 2026, which inserts "51. Pregabalin" into Schedule H1 of the Drugs Rules, 1945. It was published in the Gazette on 20 May 2026 after a draft, G.S.R. 54(E), in January. Deccan Herald and Indian Pharma Post reported that the drug moves from Schedule H, and that it "can now be sold only against a valid prescription", with chemists keeping a separate register and makers printing a Schedule H1 warning. The Week reported that states had flagged misuse, particularly among young people.
The rules state that they "shall come into force after one eighty days" from publication. Read as 180 days, that falls in November 2026, so the Schedule H1 conditions may not yet apply on the date of this page. Pregabalin was already a prescription drug before the change.
Separately, on 11 April 2025 the CDSCO told state licensing authorities to halt a pregabalin SR 75 mg + nortriptyline + vitamin D3 + mecobalamin tablet, one of 35 combinations licensed without central approval. That is a direction to states about one product, not a ban on pregabalin.
What this means for you
It is still a legal medicine
Pregabalin can be prescribed and sold. No strength, including 300 mg, is banned.
Expect stricter checks at the chemist
Under Schedule H1 the chemist must see a prescription and record the sale in a separate register.
Combination packs need a check
A pregabalin tablet that adds nortriptyline, vitamin D3 and mecobalamin was halted in April 2025.
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 pregabalin 300 mg banned in India?
No. No order bans pregabalin at 300 mg or any strength; it is moving to Schedule H1 under G.S.R. 377(E) of 13 May 2026.
Is pregabalin a Schedule H1 drug?
G.S.R. 377(E) adds it to Schedule H1. The rules take effect after the delay they set, read as 180 days from 20 May 2026.
Is any pregabalin combination banned?
A pregabalin SR 75 mg + nortriptyline + vitamin D3 + mecobalamin tablet was halted by the CDSCO on 11 Apr 2025.
Entries on the banned drugs list
| Drug / combination | Action | Notification | Date | Status note |
|---|---|---|---|---|
| Pregabalin (SR) 75mg + Nortriptyline 10mg + Vitamin D3 2000IU + Mecobalamin 1500mcg Tablet | Halted | CDSCO F.No. 4-01/2023-DC (Misc. 3) dated 11.04.2025, Annexure Sr. 12 | 11 April 2025 | CDSCO direction to state licensing authorities, 11 Apr 2025, not a Section 26A gazette ban |
Ingredient records
Every banned combination and failed batch containing each ingredient.
Batches declared Not of Standard Quality
Batches of products containing Pregabalin flagged in CDSCO monthly alerts. An NSQ result concerns one batch, not the molecule or the brand.
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Pregabalin Sustained Release Tablets | Batch VGT261113Mfg Mar 2026 · Exp Feb 2028 | Vrindavan GlobalHimachal Pradesh | The Sample failed in Assay (i.e. Label Claim) of Pregabalin as mentioned under Standards 1940 and Rules for Patent there under.Assay | SDTL, Andhra PradeshState lab | Aug 2026 |
| Pregabalin IP 75mg, Nortripyline 10mg and Methylcobalamin IP 1500mcg, | Batch ADT252729AMfg Oct 2025 · Exp Sep 2027 | Astonea Labs Pvt. LtdHaryana | The content of Methylcobalamin found to be 668.61 mcg per tablet (44.574%) against labelled claim of 1500 mcg per tablet.Labelling | Govt Analyst PunjabState lab | Jul 2026 |
| Pregabalin Capsules IP 300mg | Batch DMC-260508AMfg May 2026 · Exp Apr 2028 | Divine Medicare | The Contents of Pregabali found to be 211.16mg/Capsule against the claim of 300.0mg/Capsule.Other | Govt Analyst PunjabState lab | Jul 2026 |
| Pregabalin capsules IP 300 mg | Batch SC2602602Mfg Feb 2026 · Exp Jan 2028 | Scout Lifescience Pvt. LtdHaryana | The sample received does not conform to the I.P. 2022 standard with respect to the test for Dissolution and DescriptionDissolution | CDTL, MumbaiCDSCO lab | May 2026 |
| Pregabalin & Nortriptyline Tablets | Batch ST25417CMfg Nov 2025 · Exp Oct 2027 | Sahika Pharmaceuticals Pvt. LtdHimachal Pradesh | The sample does not conform to Manufacturer's Specification with respect to Assay of PregabalinAssay | CDL, KolkataCDSCO lab | May 2026 |
| Pregabalin, L-Methyl folate Calcium, Pyridoxal 5 Phosphate, Alpha lipoic acid & Methylcobalamin Tablets | Batch MT-250016Mfg Jan 2025 · Exp Dec 2026 | Matins Healthcare Pvt. LtdUttarakhand | Test for DisintegrationDisintegration | DTL, Bengaluru, KarnatakaState lab | Mar 2026 |
| Pregabalin & Methylcobalamin Capsules IP | Batch PGC2508006CMfg Aug 2025 · Exp Jan 2027 | Asterisk Healthcare | DissolutionDissolution | SDTL, PunjabState lab | Mar 2026 |
| Pregabalin & Methylcobalamin Capsule IP | Batch 25DC015AMfg Aug 2025 · Exp Jan 2027 | Mas Kashmik Formulation Pvt. Ltd. Pf-13Gujarat | The content of MethylcobalminOther | FDAL, MumbaiState lab | Mar 2026 |
| Pregabalin capsules IP 300mg | Batch LPC25138Mfg Dec 2025 · Exp Nov 2027 | Levotic Pharma | The contents of Pregabalin found to be 345.40mg per Capsule (115.13%) against labeled claim of 300.0mg per capsule.Labelling | SDTL, PunjabState lab | Feb 2026 |
| Pregabalin & Nortriptyline Tablets | Batch PT-042515Mfg Apr 2025 · Exp Mar 2027 | Primus PharmaceuticalsHimachal Pradesh | The sample does not conform to the claim with respect to Assay in Nortriptyline.Assay | DTL JaipurState lab | Jan 2026 |
| Pregabaline & Nortriptyline Tablets (DGABA-N Tablets,) | Batch VGT242301BMfg Nov 2024 · Exp Oct 2026 | Vrindavan GlobalHimachal Pradesh | Misbranded.Misbranded | DCL TelanganaState lab | Dec 2025 |
| Pregabalin & Methlcobalamin Capsules IP (Neujan Capsules) | Batch MMC-1957Mfg Jan 2024 · Exp Dec 2025 | Mayoford PharmaHimachal Pradesh | Test for Uniformity of WeightUniformity of weight/content | DTL, Bengaluru, KarnatakaState lab | Oct 2025 |
| Baptar NM Tablet (Pregabalin Methylcobalamin & Nortriptyline Tablets) | Batch UGT-25134EMfg Jan 2025 · Exp Dec 2026 | Ultra Drugs Pvt. LtdHimachal Pradesh | AssayAssay | DTL Baddi H.PState lab | Oct 2025 |
| PREGABALIN AND METHYLCOBALA MIN CAPSULES (Amalin Plus) | Batch MDP- 774Mfg ? · Exp ? | Medinok Healthcare Pvt. LtdPuducherry | The sample received is labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES, however PREGABALIN AND METHYLCOBALAMIN CAPSULES is an official IP monograph (2022) hence should be labelled as PREGABALIN AND METHYLCOBALAMIN CAPSULES IP- MisbrandedMisbranded | PuducherryState lab | Feb 2025 |
| Pregabalin (SR) & Methylcobal amin Tablet (Mecoben ? PG) | Batch MP - 240724Mfg Oct 2024 · Exp Sep 2026 | Medistark Biotech Pvt. Ltd. R.S.No. 68/4 | The label of the container in the drug is mentioned as 'Approved colour used' but the common name of the permitted colour used in the formulation as prescribed under rule 127 (2) of the drug rule was not mentioned. - MisbrandedMisbranded | State Lab PuducherryState lab | Jan 2025 |
Sources
Government documents
- G.S.R. 377(E): Drugs (Second Amendment) Rules, 2026 (Gazette copy)GazetteGazette of India (MoHFW), copy hosted by TaxHeal · 20 May 2026
- CDSCO letter F.No. 4-01/2023-DC (Misc. 3), 11 Apr 2025: 35 FDCs to be haltedRegulatorCDSCO · 11 April 2025
News reports
- Health ministry classifies Pregabalin under Schedule H1 to curb misuseNewsIndian Pharma Post · 23 May 2026
- News
- Drug use or abuse? Here is why India tightened its regulations on PregabalinNewsThe Week · 22 May 2026