The Central Drugs Standard Control Organization (CDSCO), India’s top drug regulatory authority, has raised serious concerns after identifying 59 commonly used medications as substandard during tests conducted in August.
These drugs, produced by some of the most well-known manufacturers in the Indian pharmaceutical industry, fail to meet the required quality standards and are deemed ‘Not of Standard Quality’ (NSQ).
The list includes essential medications such as antibiotics, blood pressure medications, diabetes control pills, vitamins, calcium supplements, Pan-D, and painkillers like meftal, and paracetamol.
Following the alert, pharmaceutical companies responsible for manufacturing these drugs have been instructed to recall the affected products from the market immediately. The CDSCO’s findings have prompted urgent action to safeguard public health, as many of these medicines are widely prescribed and consumed across India.
Among the flagged medicines are essential health products such as Vitamin C and Vitamin D3 tablets, Vitamin B complex supplements, diabetes medications, and high blood pressure pills. The investigation revealed that these medicines do not meet the prescribed safety and quality benchmarks, making them unsuitable for patient use.
These drugs include:
| S.No | Product/Drug Name | Batch No. | Manufacturing Date | Expiry Date | Manufactured By | NSQ Result | Reported by CDSCO Laboratory |
|---|---|---|---|---|---|---|---|
| 1 | Amoxicillin And Potassium Clavulanate Tablets IP (Clavam 625) | 23443940 | 11/2023 | 04/2025 | M/s. Alkem Health Science, Unit-2, Samardung, Karek Block, P.O. Namthang, South Sikkim 737 137 | Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium Clavulanate | CDL, Kolkata |
| 2 | Amoxycillin & Potassium Clavulanate Tablets (Mexclav 625) | 7372 | 10/2023 | 09/2025 | M/s. Meg Lifesciences, Khasara No. 47/5, Palli Gaon, Distt-Sirmour- 173001 | Spurious Identification & Assay of Amoxycillin Trihydrate & Potassium Clavulanate | CDL, Kolkata |
| 3 | Calcium And Vitamin D3 Tablets IP Shelcal 500 (Shelcal) | GDXD0581 | 08/2023 | 07/2025 | M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, IIE, SIDCUL, Ranipur, Haridwar 249403, Uttarakhand | Description, Identification of Vitamin D3, Dissolution of Calcium, Assay of Calcium & Vitamin D3 | CDL, Kolkata |
| 4 | Metformin Hydrochloride Sustained-release Tablets IP (Glycimet-SR-500) | GT3J023 | 10/2023 | 09/2025 | M/s. Scott-Edil Pharmacia Ltd., 56, EPIP, Phase-1, Jharmajri, Baddi, Distt. Solan -173205 (HP), India | Dissolution of Metformin Hydrochloride | CDL, Kolkata |
| 5 | Vitamin B Complex with Vitamin C Softgels | 1423 | 09/2023 | 08/2025 | M/s. Asoj Soft Caps Pvt. Ltd., Asoj, Baroda-Halol Highway, Dist-Baroda- 391510, Gujarat | Assay of Calcium Pantothenate | CDL, Kolkata |
| 6 | Rifmin 550 (Rifaximin Tablets 550 mg) | TX-17798 | 02/2024 | 01/2026 | M/s. Legen Healthcare, Plot No. 20, Sector-5, Parwanoo, Distt. Solan (H.P.) 173220 | Dissolution & Water | CDL, Kolkata |
| 7 | Pantoprazole Gastro-Resistant and Domperidone Prolonged-Release Capsules IP (Pan – D) | 23444296 | 12/2023 | 11/2025 | M/s. Alkem Health Science, Unit-2, Samardung, Karek Block, P.O. Namthang, Dist. Namchi, Sikkim 737 137 | Spurious Identification, Assay, Dissolution & Related Substances | CDL, Kolkata |
| 8 | Paracetamol Tablets IP 500 mg | 2508323 | 02/2023 | 01/2026 | M/s. Karnataka Antibiotics and Pharmaceuticals Ltd., Plot No. 14, II Phase, Peenya, Bengaluru-560058 | Description | CDL, Kolkata |
| 9 | Montain LC Kid (Montelukast Sodium & Levocetirizne Hydrochloride Dispersible Tablets) | AFB23W73 | 09/2023 | 08/2025 | M/s. Pure & Cure Healthcare Pvt. Ltd., Plot No. 26A, 27-30, Sector-8A, IIE, Sidcul, Ranipur, Haridwar 249 403, Uttarakhand | Uniformity of Dispersion & Assay of Montelukast Sodium | CDL, Kolkata |
| 10 | Compound Sodium Lactate Injection I.P. (Ringer Lactate Solution for Injection) (RL 500 ml) | MP24050511 1 | 05/2024 | 04/2027 | M/s. Vision Parenteral Pvt. Ltd., A-2, 44,45, Sector-15, GIDA, Sahjanwa (U.P.) 273 209 | Assay of Calcium Chloride | CDL, Kolkata |
| 11 | Fexofenadine Hydrochloride Tablets IP 120 mg | MP9AA2303 | 07/2023 | 06/2026 | M/s. Maxtar Bio-Genics, Khasra No-705, Vill-Malku Majra, Nalagarh Road, Baddi, Distt-Solan- 173205 (HP), India | Dissolution | CDL, Kolkata |
| 12 | Fexofenadine Hydrochloride Tablets IP 120 mg | MP9AA2303 (Two different) | 07/2023 | 06/2026 | M/s. Maxtar Bio-Genics, Khasra No-705, Vill-Malku Majra, Nalagarh Road, Baddi, Distt-Solan- 173205 (HP), India | Dissolution | CDL, Kolkata |
Notably, several prominent pharmaceutical companies are involved in this issue, including Hetero Drugs, Alkem Laboratories, Vision Parenteral, Hindustan Antibiotics Limited, Karnataka Antibiotics and Pharmaceuticals Limited, Meg Lifesciences, and Pure and Cure Healthcare.
These firms now face the task of recalling their substandard products while also addressing regulatory scrutiny. The CDSCO issues regular alerts to ensure transparency and maintain drug quality in India.
Consumers and healthcare professionals are advised to remain vigilant and avoid using the affected products until further notice. This incident underlines the importance of stringent quality control measures in the pharmaceutical industry to protect patient safety and ensure the reliability of essential medicines in the market.
