CDSCO Panel Rejects Troikaa Pharma's High-Strength Paracetamol Injection Citing Safety Concerns
New Delhi: 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.
The firm had appeared before the committee to provide clarifications on observations made during the SEC meeting dated June 24, 2025, regarding its earlier submission. Troikaa Pharmaceuticals proposed the Paracetamol Injection 1000 mg/4 ml as a new high-strength parenteral formulation intended to provide rapid pain and fever relief, positioning it as an alternative to the existing Paracetamol solution for infusion 10 mg/ml (1000 mg/100 ml).
After reviewing the company’s submission and clarifications, the SEC (Analgesic & Rheumatology), following detailed deliberation, opined that:
a) The applied indication can be appropriately addressed with the currently available Paracetamol solution for infusion 10 mg/ml (1000 mg/100 ml) formulation.
b) There is no superiority or additional therapeutic benefit with Paracetamol 1000 mg/4 ml injection over the existing Paracetamol infusion 10 mg/ml (1000 mg/100 ml) formulation.
c) As per the product information, if the diluted solution is not used within 8 minutes, crystallization may occur, posing an additional risk for patient safety.
d) The Paracetamol 1000 mg/4 ml injection demonstrated significantly higher Cmax and AUC (0–t/0–∞) compared to the Paracetamol intravenous infusion (10 mg/ml, 1000 mg/100 ml), which may lead to liver toxicity.
Based on these findings, the SEC did not recommend the grant of permission for the manufacture and marketing of Paracetamol Injection 1000 mg/4 ml, concluding that the proposed product offers no additional clinical advantage and poses potential safety risks.
Paracetamol (acetaminophen) is a commonly used analgesic and antipyretic drug prescribed for mild to moderate pain and fever. Troikaa Pharmaceuticals Limited specializes in developing advanced injectable drug delivery systems and has a strong portfolio in pain management formulations.
