CDSCO Panel Rejects Troikaa Pharma's High-Strength Paracetamol Injection
Ahmedabad-based pharma firm, Troikaa Pharmaceuticals Limited, has been refused approval by the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organization (CDSCO) for its proposed Paracetamol Injection 1000 mg/4 ml.
The decision was made during the committee’s 8th meeting held on September 17, 2025, at CDSCO headquarters in New Delhi, citing safety concerns.
Troikaa Pharmaceuticals Limited had appeared before the committee to provide clarifications on observations made during the SEC meeting dated June 24, 2025, regarding its earlier submission.
No further details on the rejection were provided.
Author summary: CDSCO rejects Troikaa Pharma's injection.