The Central Drugs Standard Control Organization (CDSCO) has released the “Not of Standard Quality” NSQ drugs alert for October 2024. This monthly update aims to inform stakeholders about pharmaceutical products that have failed to meet quality standards. It is an alert for the common public to avoid consumption of listed products.
What are NSQ Drugs?
NSQ drugs are those that fail to comply with the quality benchmarks specified under Section 16(1)(a) of the Drugs & Cosmetics Act, of 1940. This Act defines “standards of quality” as compliance with specifications outlined in the Second Schedule of the legislation.
Consolidated list of NSQ drugs alert for October 2024
- Absorbent Cotton Wool IP
- Batch: 2013
- Issue: Surface active substances, sulphated ash, fluorescence, water-soluble substances.
- Manufacturer: M/s Jind Surgicals, Haryana.
- Trypsin & Chymotrypsin Tablets (Lysoflam Forte)
- Batch: LFTF24002C
- Issue: Assay of Trypsin & Chymotrypsin.
- Manufacturer: M/s Cachet Pharmaceuticals, Himachal Pradesh.
- Chlorhexidine Gluconate Solution 4% w/v
- Batch: 012
- Issue: Assay.
- Manufacturer: M/s Overseas Chemicals, West Bengal.
- Diclofenac Sodium, Paracetamol & Chlorzoxazone Tablets
- Batch: DCPT3310
- Issue: Disintegration.
- Manufacturer: M/s Modern Laboratories, Madhya Pradesh.
- Hydroquinone, Tretinoin & Allantoin Cream (Lumadip)
- Batch: LD-18
- Issue: Description & pH.
- Manufacturer: M/s Tosc International Pvt. Ltd., Uttarakhand.
- Liposomal Amphotericin B Injection 50 mg (Ambilip)
- Batch: ALLC4A1
- Issue: Bacterial endotoxins, Assay of Amphotericin B.
- Manufacturer: M/s United Biotech Pvt. Ltd., Himachal Pradesh.
- Ornidazole & Ofloxacin Tablets IP
- Batch: HOOA07
- Issue: Description.
- Manufacturer: M/s Hindustan Antibiotics Ltd., Haryana.
- Amlodipine and Perindopril Tablets (Amtas PRP)
- Batch: K2201310
- Issue: Assay of Perindopril Erbumine.
- Manufacturer: M/s Intas Pharmaceuticals Ltd., Sikkim.
- Decitabine for Injection 50 mg/vial
- Batch: H230266
- Issue: Water content.
- Manufacturer: M/s Dr. Reddy’s Laboratories, Andhra Pradesh.
- Natamycin Ophthalmic Suspension IP (Nataprime Eye Drops)
- Batch: PE062308
- Issue: Sterility.
- Manufacturer: M/s Primus Pharmaceuticals, Himachal Pradesh.
- Iron Sucrose Injection USP 5 ml
- Batch: IRA12320, MA24B129
- Issue: Specific gravity, particulate matter, assay discrepancies.
- Manufacturers: M/s Nandani Medical Labs, M/s Martin & Brown Biosciences.
- Paclitaxel Injection IP
- Batch: OI220089A
- Issue: Description, particulate matter.
- Manufacturer: M/s Cosmas Research Lab Ltd., Punjab.
- Glucosamine Sulfate Potassium Chloride Tablets (Orcerin GM)
- Batch: KOO2207A
- Issue: Description.
- Manufacturer: M/s Macleods Pharmaceuticals, Sikkim.
- Buprenorphine Injection I.P. (Lupigesic)
- Batch: 1470 ASG
- Issue: Assay of Buprenorphine.
- Manufacturer: M/s SMG Pharmaceuticals, Gujarat.
- Telmisartan Tablets IP 40 mg (Telesky-40)
- Batch: Multiple batches.
- Issue: Dissolution issues.
- Manufacturer: M/s Life Max Cancer Laboratories, Uttarakhand.
- Amoxycillin and Potassium Clavulanate Tablets IP
- Batch: MBT23068
- Issue: Assay discrepancies.
- Manufacturer: M/s Mediwell Biotech, Himachal Pradesh.
- Pantoprazole Sodium & Domperidone Capsules (Penstal-DSR)
- Batch: C582
- Issue: Dissolution of Domperidone.
- Manufacturer: M/s Stallion Laboratories, Gujarat.
- Racecadotril & Ofloxacin Suspension (Combact-O)
- Batch: L23J003A
- Issue: Assay of ingredients.
- Manufacturer: M/s Bajaj Formulations, Uttarakhand.
- Metronidazole Tablets (Metagyl-400)
- Batch: B22-275
- Issue: Dissolution.
- Manufacturer: M/s Saint Michael Biotech, Uttarakhand.
- Aceclofenac & Paracetamol Tablets (Eldigesic-P)
- Batch: AGT305144
- Issue: Assay of Aceclofenac.
- Manufacturer: M/s Alventa Pharma, Himachal Pradesh.
- Rabeprazole Sodium & Domperidone SR Capsules (RABALKEM-DSR)
- Batch: RKBC22064S
- Issue: Assay of Rabeprazole.
- Manufacturer: M/s Shiva Biogenetic Laboratories Pvt. Ltd., Himachal Pradesh.
- Aceclofenac, Paracetamol, and Serratiopeptidase Tablets (Megaceclo SP)
- Batch: AMT2302037
- Issue: Description and Assay of Serratiopeptidase.
- Manufacturer: M/s Marine Medicare Pvt. Ltd., Himachal Pradesh.
- Enrofloxacin Injection IP (Vet.) (ENROXACIN Vet Injection)
- Batch: LV326
- Issue: pH.
- Manufacturer: M/s Lavista Ideal Pharmacy Pvt. Ltd., Himachal Pradesh.
- Rabeprazole Sodium & Domperidone Capsules (ZABIL-DSR)
- Batch: UD2C-23469E
- Issue: Dissolution of Rabeprazole & Domperidone; Assay of Domperidone.
- Manufacturer: M/s Ultra Drugs Pvt. Ltd., Himachal Pradesh.
- Calcium 500 mg with Vitamin D3 250 IU Tablets IP
- Batch: LMT240377
- Issue: Dissolution of Calcium; Assay of Vitamin D3.
- Manufacturer: M/s Life Max Cancer Laboratories, Uttarakhand.
- Glimepiride Tablets IP 2 mg
- Batch: LMT240333
- Issue: Dissolution.
- Manufacturer: M/s Life Max Cancer Laboratories, Uttarakhand.
- Adrenaline Injection IP 1.8 mg/ml (Adrenascot)
- Batch: GA3A020
- Issue: Appearance of Solution; Description.
- Manufacturer: M/s Scott-Edil Pharmacia Ltd., Himachal Pradesh.
- Buprenorphine Injection IP (LUPIGESIC)
- Batch: 1470 ASG
- Issue: Assay of Buprenorphine.
- Manufacturer: M/s SMG Pharmaceuticals, Gujarat.
- Telmisartan Tablets IP 40 mg (Telesky-40 Tablet)
- Batch: CMT23-1658
- Issue: Dissolution.
- Manufacturer: M/s Cortex Medical Inc., Himachal Pradesh.
- Telmisartan Tablets IP 40 mg
- Batch: LMT240611Issue:
- Description.
- Manufacturer: M/s Life Max Cancer Laboratories, Uttarakhand.
- Telmisartan Tablets IP 40 mg
- Batch: LMT240536
- Issue: Description.
- Manufacturer: M/s Life Max Cancer Laboratories, Uttarakhand.
- Buprenorphine Injection IP (LUPIGESIC)
- Batch: 1470 ASG
- Issue: Assay/Content of Buprenorphine.
- Manufacturer: M/s SMG Pharmaceuticals, Gujarat.
- Ciprofloxacin Tablets IP 250 mg
- Batch: CT23241818
- Issue: Dissolution of Ciprofloxacin.
- Manufacturer: M/s CMG Biotech Pvt. Ltd., Himachal Pradesh.
- Esomeprazole Tablets IP 40 mg (Essokynt-40)
- Batch: TT23-505
- Issue: Dissolution (Buffer Stage).
- Manufacturer: M/s Tanishka Pharmaceuticals, Himachal Pradesh.
- Fexofenadine Hydrochloride Tablets IP
- Batch: T-2403971
- Issue: Dissolution of Fexofenadine Hydrochloride.
- Manufacturer: M/s Oscar Remedies Pvt. Ltd., Haryana.
- Paracetamol Tablets IP 500 mg (Pararex-500)
- Batch: CT-7129
- Issue: Dissolution.
- Manufacturer: M/s Chemetac Pharmaceuticals, Uttar Pradesh.
- Ciprofloxacin Tablets USP 500 mg
- Batch: T-2401066
- Issue: Dissolution.
- Manufacturer: M/s Rivpra Formulation Pvt. Ltd., Uttarakhand.
- Metronidazole 400 mg Tablets (Metagyl-400)
- Batch: B22-275
- Issue: Dissolution of Metronidazole.
- Manufacturer: M/s Saint Michael Biotech, Uttarakhand.
- Aceclofenac & Paracetamol Tablets (Eldigesic-P)
- Batch: AGT305144
- Issue: Assay of Aceclofenac.
- Manufacturer: M/s Alventa Pharma, Himachal Pradesh.
- Sodium Fusidate Cream 2%
- Batch: 344
- Issue: Assay.
- Manufacturer: M/s Bharat Parenterals Limited, Gujarat.
- Enalapril Maleate Tablets IP 5 mg (Opioril-5)
- Batch: 23HT1771
- Issue: Dissolution and Assay of Enalapril Maleate.
- Manufacturer: M/s Orison Pharma International, Himachal Pradesh.
- Bupropion Hydrochloride Tablets USP 150 mg (Brudel SR-150)
- Batch: T23169
- Issue: Assay of Bupropion Hydrochloride.
- Manufacturer: M/s Rebase Lifescience Pvt. Ltd., Gujarat.
- Propylene Glycol USP/IP
- Batch: BT1205B25122023
- Issue: Water.
- Manufacturer: M/s Balaji Amines Limited, Maharashtra.
- Racecadotril & Ofloxacin Suspension (Combact-O Suspension)
- Batch: L23J003A
- Issue: Assay of Racecadotril & Ofloxacin.
- Manufacturer: M/s Bajaj Formulations, Uttarakhand.
- Pantoprazole Sodium and Domperidone Capsules (Penstal-DSR)
- Batch: C582
- Issue: Dissolution of Domperidone.
- Manufacturer: M/s Stalion Laboratories, Gujarat.
- Terbinafine Hydrochloride Tablets IP (TERBONATE-250)
- Batch: NT-7900
- Issue: Test for Dissolution.
- Manufacturer: M/s Neptune Life Sciences Pvt. Ltd., Himachal Pradesh.
- Ondansetron Injection IP 2mg/ml
- Batch: OT-5411
- Issue: Sterility.
- Manufacturer: M/s Alchemist Remedies Pvt. Ltd., Madhya Pradesh.
- Single-Use Syringe (EDGEX)
- Batch: 5DSB27
- Issue: Cleanliness and Design of Piston/Plunger Assembly.
- Manufacturer: M/s Noble Pharmacare Ltd., Odisha.
- Rabeprazole Sodium (EC) and Levosulpiride (SR) Capsules (RPL LS Capsules)
- Batch: CGC-24020
- Issue: Dissolution of Levosulpiride.
- Manufacturer: M/s Calrax Healthcare Pvt. Ltd., Himachal Pradesh.
- Amoxycillin and Potassium Clavulanate Tablets IP (Moxileb-CV 625)
- Batch: MBT23068
- Issue: Assay of Amoxycillin Trihydrate.
- Manufacturer: M/s Mediwell Biotech, Himachal Pradesh.
- Pantoprazole Tablets IP
- Batch: MT-23J13
- Issue: Dissolution (Buffer Stage).
- Manufacturer: M/s Martin & Brown Biosciences, Himachal Pradesh.
- Aciclovir Intravenous Infusion IP 250 mg (Acyclotech Injection)
- Batch: D0072406B
- Issue: Assay of Aciclovir.
- Manufacturer: M/s Protech Telelinks, Himachal Pradesh.
- Ceftriaxone and Sulbactam for Injection (Tykone-S Injection)
- Batch: UNI-240013
- Issue: Particulate Matter.
- Manufacturer: M/s Unital Formulations, Himachal Pradesh.
- Ampicillin Powder for Injection 1000 mg
- Batch: EXPN-24004
- Issue: Particulate matter and Assay of Ampicillin Sodium.
- Manufacturer: M/s Unital Formulations, Himachal Pradesh.
- Amoxycillin and Potassium Clavulanate Injection (Manclav 300 mg)
- Batch: HIAP23001A
- Issue: Particulate matter and Assay of Potassium Clavulanate.
- Manufacturer: M/s Health Biotech Ltd., Himachal Pradesh.
- Meropenem Injection IP (ZENEM 1 g Injection)
- Batch: B240720D
- Issue: Particulate matter and Content of Sodium.
- Manufacturer: M/s Oscar Remedies Pvt. Ltd., Haryana.
Motive of the NSQ List by CDSCO
The publication of the NSQ products list promotes transparency and ensures that stakeholders in the pharmaceutical supply chain—manufacturers, distributors, healthcare professionals, and consumers—remain vigilant about the drugs circulating in the market and avoid consuming them for various illness symptoms because they will not fulfill the intent for they were manufactured.
Impact on NSQ lists:
- Healthcare Providers: Reassess the safety and efficacy of prescribed medications.
- Manufacturers: Address the compliance gaps to ensure product quality and make them more vigilant towards product quality.
- Consumers: Verify product details to avoid using potentially harmful medications that may prove dangerous for their health.
References:
- Section 16 in The Drugs And Cosmetics Act, 1940-IndianKanoon(.org)
- Circular/Orders-CDSCO
