Troikaa's Fast-Acting Paracetamol Shot Hits Regulatory Hurdle, CDSCO Panel Seeks More Data
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has asked Troikaa Pharmaceuticals Ltd. to submit additional data, literature, or study protocol for its proposed Paracetamol 1000 mg/4 ml intravenous bolus injection formulation, citing concerns about injection site pain, adverse events, clinical indications, and administration logistics.
This recommendation came during the SEC (Analgesic & Rheumatology) meeting held on 24th June 2025, where the company presented its Phase III clinical trial report for regulatory review.
Paracetamol, classified as a non-steroidal anti-inflammatory drug (NSAID), is widely used for the treatment of mild to moderate pain and fever. Troikaa’s formulation proposes a high-concentration intravenous bolus injection, intended to be administered over 2 minutes, compared to the standard 15-minute infusion of existing IV paracetamol formulations.
Following detailed deliberations, the committee made the following observations:
“Injection site pain observed in subjects treated with test product Paracetamol 1000 mg/4 ml injected as intravenous bolus over 2 minutes (fast administration rate) reported to be comparable with injection site pain with reference product paracetamol intravenous infusion 1% w/v (100 ml) infused over 15 minutes (slow administration rate), which is further required to be supported by additional study.”
Additionally, the committee flagged the absence of commonly expected intravenous paracetamol-related side effects in the trial:
“Adverse events like facial flushing, transient hypotension, arrhythmias, liver toxicity (toxicity by international normalized ratio) has not been observed and reported in the trial results... which are otherwise common side effects of paracetamol through I.V. route. Firm needs to clarify the same with relevant data and additional study.”
The SEC also stated that the indications proposed by the firm—including management of mild to moderate pain, moderate to severe pain with adjunctive opioid analgesics, and treatment of fever—were not supported by the presented clinical trial report, literature, or data.
Furthermore, the committee raised concerns regarding the practicality of administering the formulation:
“Firm needs to address concerns w.r.t. availability of 20 ml syringe for injecting the proposed formulation and its controlled flow rate administration etc.”
In light of these observations, the SEC concluded:
“Accordingly, committee recommended that firm should submit the additional data/ literature/ study protocol etc. to address above mentioned observations.”
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