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The Indian Pharmacopoeia Commission (IPC) launched seven Indian Pharmacopoeia Nitrosamine Impurities Reference Standards on 25 August 2026 - the first such standards it has issued.
The launch took place at the IPC's first-ever interactive meeting at the Central Drugs Laboratory and Central Cosmetics Laboratory, Kolkata.
The seven standards cover NDMA, NDEA, NEIPA, NDBA, NMPA, NDIPA and NMBA.
Nitrosamines are genotoxic and carcinogenic compounds that can form unintentionally during the manufacturing, packaging or storage of medicines.
Controlling them matters most for chronic-use medicines for hypertension, gastric disorders, diabetes and tuberculosis.
A reference standard is a highly characterised sample of a known substance against which a laboratory compares an unknown one. Without it, a testing lab can detect that 'something' is present in a drug sample but cannot say what it is or how much of it there is. Issuing nitrosamine reference standards therefore lets Indian regulatory and industry laboratories identify and quantify these specific impurities domestically, instead of depending on imported standards. Pharmacopoeial standards more broadly define the identity, purity, strength and quality of a medicine, and are used in regulatory testing and in drafting official drug monographs.
Simple Analogy: It is the calibrated weight kept beside a balance: you cannot state how heavy something is until you have a known weight to measure it against.
Autonomous national body that sets drug standards and publishes the Indian Pharmacopoeia
Central government drug-testing laboratory; venue of the launch
Administrative ministry for the IPC
Recognises the Indian Pharmacopoeia as the official book of drug standards for medicines marketed in India.
GS Paper II > Health; GS Paper III > Science and Technology
General Awareness > Organisations and Science
General Awareness > Government Bodies
General Awareness > Science and Institutions
A class of genotoxic and carcinogenic compounds that can form unintentionally in medicines during manufacture, packaging or storage.
A highly characterised sample of a known substance used by laboratories to identify and quantify that substance in test samples.
The official book of standards for drugs in India, published by the IPC and recognised under the Drugs and Cosmetics Act, 1940.
Capable of damaging genetic material, a property that can lead to cancer.