India releases a domestic enoxaparin reference standard for laboratory bioassays
The authenticated material is intended to support more consistent assessment of the anticoagulant's biological activity.
The Indian Pharmacopoeia Commission has released an Indian Pharmacopoeia Reference Substance for enoxaparin sodium bioassays during a national conference in Bengaluru.
IPC says the authenticated material is intended to support accurate, consistent and comparable assessment of biological activity. The conference also covered analytical characterisation, comparability, immunogenicity, pharmacovigilance and regulatory expectations.
Why it matters
Reliable reference materials underpin laboratory comparability, quality control and regulatory confidence for complex biological medicines and anticoagulant testing.
SCULTRA point of view
Domestic reference infrastructure can improve consistency, but confidence depends on transparent characterisation, traceability, laboratory proficiency and alignment with recognised standards.
Limitations
The release announces the reference substance, not validation results, inter-laboratory performance, product approvals or evidence that any biosimilar is safe or equivalent.
Source: Press Information Bureau / Indian Pharmacopoeia Commission, 11 September 2026, 5:00 PM IST.