SEC Flags Safety, Efficacy Gaps in Troikaa's Rapid IV Paracetamol Bolus Proposal, Seeks More Data
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has declined to approve Troikaa Pharmaceuticals' proposed Paracetamol 1000 mg/4 ml intravenous bolus injection, citing insufficient safety and efficacy data.
During its meeting on June 24, 2025, the committee raised concerns over lack of expected adverse event reporting, unsupported indications, and practical administration issues, and has directed the firm to submit additional data before reconsideration.
The formulation involves administering paracetamol 1000 mg/4 ml as a rapid intravenous bolus over 2 minutes, which the company proposed as an alternative to the existing paracetamol intravenous infusion (1% w/v, 100 ml) that is typically infused over 15 minutes.
Upon review of the Phase III trial results, the committee made the following observations:
Injection site pain, observed in subjects treated with the test product (Paracetamol 1000 mg/4 ml IV bolus over 2 minutes), was reported to be comparable to that with the reference product (paracetamol 1% IV infusion over 15 minutes). However, this comparison was considered inconclusive, and the SEC stated that it requires support from additional studies.
Commonly expected adverse events such as facial flushing, transient hypotension, arrhythmias, and liver toxicity (measured via international normalized ratio) were not reported in the trial. Since these effects are known to occur with IV paracetamol, the committee noted that the firm must clarify the absence of these adverse events with relevant data and additional study evidence.
The indications applied for, including the management of mild to moderate pain, moderate to severe pain with adjunctive opioid analgesics, and treatment of fever, were considered not supported by the presented clinical trial data, published literature, or supplementary documentation.
Practical concerns were also raised regarding the availability of suitable 20 ml syringes for administering the proposed concentrated formulation and ensuring controlled flow rate during its rapid intravenous administration.
In conclusion, the committee advised Troikaa Pharmaceuticals to submit additional data, scientific literature, and study protocols to address the above observations. The proposal was not granted approval at this stage.
Paracetamol, a widely used antipyretic and analgesic, is commonly administered intravenously for acute pain and fever. While standard IV formulations require longer infusion times, this new concentrated bolus format proposes quicker administration but raises regulatory concerns regarding safety and practical use.
