8 Drug Batches from 3 Pharma Firms Banned in Punjab After ADR Reports
Amritsar: Following multiple reports of suspected Adverse Drug Reactions (ADRs) from district hospitals and other public health institutions, the Directorate of Health and Family Welfare, Punjab, has issued an urgent directive instructing all Civil Surgeons and Medical Superintendents at MKH Patiala and DH Jalandhar to immediately discontinue the use, issue, and procurement of specific drugs and intravenous (IV) fluids in government health facilities across the state.
The directive identifies eight products and batch numbers, primarily used for IV therapy and antibiotic administration, that have been linked to the reported adverse reactions.
The list includes Normal Saline (Sodium Chloride I.P. 0.9%) bearing batch numbers S1FBY463 and S1FBY467; Dextrose Injection IP 5% (Batch No. D1FBX109); Ciprofloxacin Injection 200 mg (Batch Nos. C1FAX17 and C1FAX23); D.N.S 0.9% (Batch Nos. 2235410 and 124356); N/2 plus Dextrose 5% IV (Batch No. 1248536); and Bupivacaine HCL with Dextrose Injection (Batch No. HIBU24014A).
The order follows multiple reports of suspected Adverse Drug Reactions (ADRs) from district hospitals and other public health institutions. According to the circular issued by the Directorate of Health and Family Welfare, Punjab, Chandigarh, the affected IV fluids belong to specific batches manufactured by Swaroop Pharmaceuticals, Otsuka Pharmaceutical India, and Health Biotech.
The circular stated,
"It has come to the notice of this office that suspected cases of Adverse Drug Reactions (ADRs) have been reported from certain health facilities following the use of specific drugs and IV fluids. As a precautionary measure, it has been decided to immediately discontinue the use of the following items until further orders."
Following is the list of drugs and intravenous (IV) fluids ordered for discontinuation:
| Sr. No. | Name of the item | Batch No. | Mfg Date | Exp Date | Mfg by |
|---|---|---|---|---|---|
| 1 | Normal Saline (Sodium Chloride I.P. 0.9%) | S1FBY463 | May-25 | Apr-28 | M/s Swaroop Pharmaceuticals Pvt. Ltd. |
| 2 | Normal Saline (Sodium Chloride I.P. 0.9%) | S1FBY467 | May-25 | Apr-28 | M/s Swaroop Pharmaceuticals Pvt. Ltd. |
| 3 | Dextrose Inj. IP 5% | D1FBX109 | Oct-24 | Sep-26 | M/s Swaroop Pharmaceuticals Pvt. Ltd. |
| 4 | Ciprofloxacin Inj. 200 mg | C1FAX17 | Nov-24 | Oct-26 | M/s Swaroop Pharmaceuticals Pvt. Ltd. |
| 5 | Ciprofloxacin Inj. 200 mg | C1FAX23 | Nov-24 | Oct-26 | M/s Swaroop Pharmaceuticals Pvt. Ltd. |
| 6 | D.N.S 0.9% | 2235410 | Dec-24 | Nov-27 | Ostuka Pharmaceutical India Pvt. Ltd. |
| 7 | N/2 plus Dextrose 5% IV | 1248536 | Dec-24 | Nov-27 | Ostuka Pharmaceutical India Pvt. Ltd. |
| 8 | Bupivacaine HCL with Dextrose Inj. | HIBU24014A | Dec-24 | Nov-26 | Health Biotech Ltd. |
Furthermore, with respect to the aforementioned medications and intravenous (IV) fluids that were ordered to be stopped, the Punjab Directorate of Health and Family Welfare specifically instructed:
"You are, therefore, directed to ensure the following actions are taken immediately:Stop the use, issue, and procurement of the above-mentioned drugs/fluids in all government health institutions under your jurisdiction."
To view the official order, click the link below:
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