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Drug standards and pharmacopoeia
India's drug standards are written by the Indian Pharmacopoeia Commission, which publishes the Indian Pharmacopoeia and supplies the reference substances a laboratory measures a batch against. Its newest is for enoxaparin sodium, an anticoagulant whose strength can only be measured biologically. The same body keeps watch on medicines and devices once they are in use, work for which a World Health Organization regional network named it a centre of excellence in August 2026.
How a drug standard is set
- A pharmacopoeia is the official book of standards a medicine must meet for identity, purity and strength.
- An Indian Pharmacopoeia Reference Substance (IPRS) is the sample a laboratory measures a batch against, so a standard has a physical yardstick and not only a printed limit.
- Biological medicines such as heparins cannot be fully characterised chemically, so their strength is measured by bioassay rather than by chemical analysis.
The Commission
Works under
- Ministry of Health and Family Welfare
Publishes
- The Indian Pharmacopoeia, the official drug standards under the Drugs and Cosmetics Act, 1940
Runs
- Pharmacovigilance Programme of India
- Materiovigilance Programme of India
What has happened
11 Sep 2026
The Indian Pharmacopoeia Commission (IPC) released an Indian Pharmacopoeia Reference Substance for enoxaparin sodium bioassays.
- Enoxaparin sodium is a low molecular weight heparin, an anticoagulant used against thromboembolic disorders.
4 Aug 2026
The World Health Organization (WHO) South-East Asia Regulatory Network (SEARN) named the IPC its Regional Centre of Excellence in Pharmacovigilance.
- The IPC is also the network's Technical Centre in Quality of Medicines.
- The WHO South-East Asia Regional Office set up SEARN in 2016.