Ingredient record · Opioid used for pain and addiction treatment
Buprenorphine: bans, restrictions and failed batches in India
Last checked 20 September 2026. Sources: CDSCO banned-drugs notifications and monthly NSQ alerts, Jan 2019 to Jul 2026
No combination containing Buprenorphine is on India's banned-drugs list. 25 batches of medicines containing Buprenorphine failed a government lab test between May 2022 and July 2026, from 11 manufacturers. A failed batch concerns that batch only, not the medicine or every brand.
On the banned-drugs list
Buprenorphine on its own is not on CDSCO's banned list. The entries below are specific combinations that contain it. Status follows CDSCO's own notes on each entry.
No entry containing Buprenorphine is on the list compiled from CDSCO's Section 26A notifications (1983 to 2026). That is not a statement that every product containing it is safe.
Products that failed lab tests
Product names as printed by the testing labs, grouped. Open a product to see every batch number.
| Product | Batches | Makers | Latest |
|---|---|---|---|
| Buprenorphine | 14 | 5 | Jul 2026 |
| Buprenorphine Naloxone Sublingual | 9 | 5 | Jul 2026 |
| Buprenorphine Nalaxone | 1 | 1 | Oct 2025 |
| Lupigesic Buprenorphine | 1 | 1 | Sep 2025 |
Most recent failed batches
| Product | Batch | Manufacturer | Reason declared NSQ | Tested by | Alert |
|---|---|---|---|---|---|
| Buprenorphine Injection IP. 2ml | BUP324040Mfg 2024-12 · Exp 2026-07 | Indus Pharma Pvt. LtdRajasthan | The sample does not conform to I.P. with respect to tests of Particulate matter and Assay of Buprenorphine.Assay | CDL, KolkataCDSCO lab | Jul 2026 |
| Buprenorphine 2 mg and Naloxone 0.5 mg Sublingual Tablets IP | 25CT0314Mfg 2025-03 · Exp 2027-02 | Consern Pharna LtdPunjab | The sample is of not of standard quality for the reason stated under DescriptionDescription | RDTL,GuwahatiState lab | Jul 2026 |
| Buprenorphine 2 mg and Naloxone 0.5 mg Sublingual Tablets I.P. | 25CT0314Mfg 2025-03 · Exp 2027-02 | Consern Pharma LimitedPunjab | The sample is not of standard quality for the reason stated under Description of the tablets.Description | RDTL, GuwahatiCDSCO lab | Jul 2026 |
| Buprenorphine Injection IP 2ml | BUP325007Mfg 2025-09 · Exp 2027-08 | Indus Pharma Pvt. LtdRajasthan | The sample does not conform to I.P. with respect to the test of Particulate Matter and for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Apr 2026 |
| Buprenorphine Injection IP | ASG1590Mfg 2022-11 · Exp 2026-10 | SNG Pharmaceuticals (p) Ltd | The sample does not conform to I.P. with respect to tests of Sterility and Assay of Buprenorphine.Assay | CDL, KolkataCDSCO lab | Apr 2026 |
| Buprenorphine Injection IP 0.3ml | AMB25003Mfg 2025-08 · Exp 2027-07 | Farbe Firma Pvt. LtdGujarat | The sample does not conform to I.P. with respect to the Test of pHpH | CDL, KolkataCDSCO lab | Mar 2026 |
| Buprenorphine Injection IP 2ml | 1364 ASOMfg 2025-06 · Exp 2028-05 | SNG Pharmaceuticals (p) LtdGujarat | The sample does not conform to IP with respect to test for Sterility, Related Substances, Particulate matter, Assay of Buprenorphine Hydrochloride and Description.Assay | CDL, KolkataCDSCO lab | Jan 2026 |
| Buprenorphine Injection IP 2ml | 1364 ASOMfg 2024-05 · Exp 2026-04 | SNG Pharmaceuticals (p) Ltd | The sample does not conform to IP with respect to test for pH, Related Substance, Particulate matter and Assay of Buprenorphine Hydrochloride.Assay | CDL, KolkataCDSCO lab | Jan 2026 |
| Buprenorphine Injection IP 2ml | BUP325004Mfg 2025-04 · Exp 2027-03 | Indus Pharma Pvt. LtdRajasthan | The sample does not conform to I.P. with respect to the Tests of Extractable volume, Particulate matter and for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jan 2026 |
| Buprenorphine Injection IP 2ml | BUP325004Mfg 2025-04 · Exp 2027-03 | Indus Pharma Pvt. LtdRajasthan | The sample does not conform I.P. with respect to the Test of Particulate matter and for the reason stated under Description.Description | CDL, KolkataCDSCO lab | Jan 2026 |
| Buprenorphine Injection IP 2ml | BUP325005Mfg 2025-05 · Exp 2027-04 | Indus Pharma Pvt. LtdRajasthan | The sample does not conform to I.P. with respect to the Tests of Particulate matter, Extractable volume and Description.Description | CDL, KolkataCDSCO lab | Jan 2026 |
| Buprenorphine and Naloxone Sublingual Tablets IP (Adnomore-N) | ADN5001Mfg 2025-04 · Exp 2028-02 | Ethicare Pharmaceuticals (P) LtdGujarat | ContentOther | SDTL, PunjabState lab | Oct 2025 |
| Buprenorphine and Naloxone Sublingual Tablets IP (Adnomore-N) | ADL5001Mfg 2025-06 · Exp 2028-05 | Ethicare Pharmaceuticals (P) LtdGujarat | ContentOther | SDTL, PunjabState lab | Oct 2025 |
| Buprenorphine and Naloxone Sublingual Tablets IP | QP-250411Mfg 2025-05 · Exp 2027-04 | QUBIT Pharmaceuticals Pvt. Ltd | ContentOther | SDTL, PunjabState lab | Oct 2025 |
| Buprenorphine and Naloxone Sublingual Tablets IP | ATN5006Mfg 2025-07 · Exp 2028-06 | Ethicare Pharmaceuticals (P) LtdGujarat | ContentOther | SDTL, PunjabState lab | Oct 2025 |
Holding a strip or bottle? The batch number is printed after "B. No." Check it against every alert. If it matches, return it to the pharmacy. What the labels mean: status guide.